[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hydrocephalus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hydrocephalus":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,33,0,25,[9,42,70,91,123,147,175,223,267,292,322,348,369,395,426,452,474,499,518,540,568,588,619,642,663],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100053347","role-of-endoscopic-third-ventriculostomy-imanagement-of-hydrocephalus-in-pediatric-age-group-clinical-and-surgical-outcome-100053347",false,"NCT07694518","Role of Endoscopic Third Ventriculostomy Imanagement of Hydrocephalus in Pediatric Age Group; Clinical and Surgical Outcome","Role of Endoscopic Third Ventriculostomy in Management of Hydrocephalus in Pediatric Age Group; Clinical and Surgical Outcome","Inclusion Criteria:\n\n* cases hydrocephalus diagnosed by CT or MRI.in pediatric age group up to 18 years\n* Both sex (males and females) will be included.\n\nExclusion Criteria:\n\n* cases with hydrocephalus associated with csf infection or hemorrhage\n* Previously operated VP shunt or ETV .\n* Mult cystic hydrocephalus","ALL","6 Months","18 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"NA","Endoscopic third ventriculostomy in cases of hydrocephalus provide less invasive and safe technique than ventriculoperitoneal Shunt also decrease complications of ventriculoperitoneal Shunt",[28],"Hydrocephalus","NOT_YET_RECRUITING","2026-07-09",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":22},"2026-07-12",{"date":37,"type":22},"2026-12-24",{"name":39,"class":40},"Sohag University","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":41},"100645209","study-of-shunt-flow-under-different-valve-settings-using-a-wireless-sensor-100645209","NCT07679035","Study of Shunt Flow Under Different Valve Settings Using a Wireless Sensor","A Prospective Study Comparing CSF Shunt Flow Between \"Virtual Off\" and \"Flow-Permissive\" Shunt Valve Settings Using a Wireless, Noninvasive Shunt Flow Sensor","Inclusion Criteria:\n\nExisting ventricular cerebrospinal fluid (CSF) shunt. Region of intact skin overlying an unambiguously identifiable, palpable, chronically indwelling ventricular shunt crossing the clavicle and appropriate in size for application of the study device.\n\nWritten informed consent provided by the participant or, when applicable, by a parent, legal guardian, health care agent, or surrogate decision maker according to local regulations.\n\nFor participants with planned \"virtual off\" measurements:\n\nExisting ventricular CSF shunt with a programmable valve that has an available manufacturer-reported \"virtual off\" setting and can be programmed noninvasively.\n\nFor participants whose valve will be adjusted to the \"virtual off\" setting during the study:\n\nSubject-reported or documented history of successful shunt valve adjustment(s).\n\nExclusion Criteria:\n\nPresence of more than one distal shunt catheter in the study device measurement region.\n\nPresence of an open wound or edema in the study device measurement region that would interfere with device placement.\n\nShunt difficult to palpate or shunt depth greater than 5 mm from the skin surface at the measurement location as determined by ultrasound.\n\nSubject-reported or documented history of serious adverse skin reactions to silicone-based adhesives.\n\nNew or worsening symptoms suggestive of shunt malfunction within the previous 7 days.\n\nUse of the study device would interfere with standard patient care, emergency surgery cannot be delayed, or study participation would interfere with optimal medical care.\n\nParticipation in another investigational procedural, pharmaceutical, or device study that may affect data collected in this study.\n\nPrevious participation in a Rhaeos clinical study using the current-generation RH05-B1 study device.\n\nFor participants with planned \"valve normal\" measurements only:\n\nInvestigator judges the participant is likely to be shunt independent (e.g., does not require a functional shunt for management of hydrocephalus).\n\nThis format follows ClinicalTrials.gov conventions by separating general criteria from those that apply only to specific participant subgroups.",{"count":50,"type":22},85,[25],"Hydrocephalus is commonly treated with a cerebrospinal fluid (CSF) shunt, a device that drains excess fluid from the brain. However, shunts can stop working over time, and determining whether fluid is flowing through a shunt can be difficult. Current diagnostic methods may require imaging studies or invasive procedures, which can be time-consuming, costly, or uncomfortable for patients.\n\nThe purpose of this study is to evaluate the performance of the Rhaeos Shunt Monitoring System (RSMS), an investigational wireless, noninvasive device designed to detect flow in implanted CSF shunts. The study will compare RSMS directly with ShuntCheck III, an FDA-cleared noninvasive device that is also used to assess CSF shunt flow. Both devices are placed on the skin over the shunt and use thermal sensing technology to evaluate whether fluid is flowing through the shunt.\n\nApproximately 85 pediatric and adult participants with an existing ventricular CSF shunt will be enrolled. Participants must have a functioning shunt and no recent symptoms suggesting shunt malfunction. Some participants with programmable shunt valves will have their valve temporarily adjusted to a manufacturer-provided \"virtual off\" setting, which is intended to substantially restrict shunt flow. These participants may also undergo measurements at their normal valve setting. Other participants will only undergo measurements at their normal valve setting.\n\nDuring the study visit, participants will undergo shunt flow assessments with both RSMS and ShuntCheck III. The order in which the devices are used will be randomized. Device measurements are collected while participants are seated upright, and participants and their treating clinicians will remain blinded to the measurement results. The study devices will not be used to make treatment decisions, and participation will not alter standard medical care. Adverse events associated with device use or valve adjustments will be monitored and recorded.\n\nThe primary goal of the study is to compare the ability of RSMS and ShuntCheck III to correctly identify shunts with flow-permissive (\"valve normal\") and restricted-flow (\"virtual off\") settings. Results from this study may help support the future development of a noninvasive tool to aid neurosurgeons in assessing CSF shunt flow. Participants are not expected to receive a direct medical benefit from taking part in the study.",[28],[55,56,57,58,59],"shunt","csf","cerebrospinal fluid","rhaeos","VP shunt","2026-06-25",{"date":62,"type":33},"2026-07-01",{"date":64,"type":22},"2026-06-30",{"date":66,"type":22},"2026-12-31",{"name":68,"class":69},"Rhaeos, Inc.","INDUSTRY",{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":41},"100535594","ultrasound-us-guided-external-ventricular-catheter-placement-100535594","NCT06253858","Ultrasound (US) Guided External Ventricular Catheter Placement","Inclusion Criteria:\n\n* Decision made to perform the procedure by the primary consultant\n* Age 18 or older\n* Neuro ICU stay\n* Newly diagnosed hydrocephalus\n* Has a recent CT within the past 24 hrs\n* Normal platelets and coagulation profile\n* No active infection or currently on antibiotics\n* The targeted fluid compartment has more than 50 percent CSF vs blood by CT scan imaging\n\nExclusion Criteria:\n\n* Age \\\u003C18\n* Not in Neuro ICU setting\n* Previous placement of a ventricular catheter\n* More than 50 percent of the fluid compartment is filled with blood by CT scan\n* Time to include in the trial prohibited by clinical personnel",{"count":77,"type":22},10,[25],"To assess the accuracy the SOLOPASS® System US based in the placement of external ventricular drain into the cranial cavity. This study will aim at evaluating the proposed efficacy of the device in targeting the brain ventricles and decrease multiple brain passes, incorrect deployment and malfunctioning of the drain.",[28],"RECRUITING","2026-06-04",{"date":84,"type":33},"2026-06-05",{"date":86,"type":33},"2026-04-01",{"date":88,"type":22},"2026-12-01",{"name":90,"class":40},"Milton S. Hershey Medical Center",{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":23,"phases":100,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":117,"leadSponsor":119,"locationsCount":122},"100639121","strategies-for-weaning-from-external-ventricular-drainage-100639121","NCT07630051","Strategies for Weaning From External Ventricular Drainage","SEVDVE2","Inclusion Criteria:\n\n* Adult patient (≥18 years)\n* Admitted to critical care for non-traumatic subarachnoid hemorrhage for less than 3 days\n* First external ventricular drain inserted within the last 3 days for hydrocephalus and\u002For intracranial hypertension\n* Patient consent, or consent from a relative, or inclusion under emergency inclusion procedure\n* Patient affiliated to or beneficiary of a social security scheme\n\nExclusion Criteria:\n\n* Moribund patient or patient with established treatment limitation\u002Fwithdrawal decisions\n* Patient with a pre-existing ventriculoperitoneal or ventriculoatrial shunt\n* Patient with chronic hydrocephalus\n* Pregnant, lactating, or parturient woman\n* Person deprived of liberty by judicial or administrative decision\n* Person under involuntary psychiatric care\n* Person under a legal protection measure\n* Concurrent participation in another study involving external ventricular drainage management",{"count":99,"type":22},170,[25],"External ventricular drainage is frequently used in neurocritical care, particularly in patients admitted for non-traumatic subarachnoid hemorrhage who develop hydrocephalus and\u002For intracranial hypertension. While external ventricular drainage is often initially lifesaving, its prolonged maintenance is associated with complications, especially infections and prolonged hospital length of stay. There is currently no consensus on the optimal weaning strategy. Two approaches are used in routine practice: direct clamping (the external ventricular drain is closed as soon as weanability criteria are met) and gradual weaning (the external ventricular drain level is progressively raised before final clamping). No randomized controlled trial has yet demonstrated the superiority of one strategy over the other in patients with non-traumatic subarachnoid hemorrhage.\n\nThe investigators hypothesize that a direct clamping strategy, combined with daily screening of standardized weanability criteria, will reduce the duration of external ventricular drain maintenance compared with the conventional gradual weaning strategy. SEVDVE-2 is a multicenter, randomized, controlled, parallel-group, single-blind superiority trial that will compare these two weaning strategies in 170 adult patients admitted to critical care for non-traumatic subarachnoid hemorrhage with a first external ventricular drain inserted within the previous 3 days. Patients will be randomized 1:1, stratified on the presence of an intraventricular hematoma. The primary outcome is the number of external ventricular drain-free days alive at Day 28.",[103,28,104,105],"Subarachnoid Hemorrhage","Intracranial Hypertension","External Ventricular Drainage",[107,103,108,109,110,111,112,113],"External Ventricular Drain","Weaning; Hydrocephalus","Intracranial Pressure","Neurocritical Care","Direct Clamping","Gradual Weaning","Randomized Controlled Trial","2026-06-01",{"date":84,"type":33},{"date":62,"type":22},{"date":118,"type":22},"2031-10-01",{"name":120,"class":121},"University Hospital, Angers","OTHER_GOV",5,{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":23,"phases":132,"briefSummary":133,"conditions":134,"keywords":135,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":143,"leadSponsor":145,"locationsCount":41},"100639551","uvc-in-prevention-of-surgical-wound-infection-100639551","NCT07600463","UVC in Prevention of Surgical Wound Infection","UVCJAS","Inclusion Criteria:\n\n* 75 patients with idiopathic normal pressure hydrocephalus (iNPH) arriving for CSF shunt procedure\n* written informed consent\n\nExclusion Criteria:\n\n* immunosupressive medication\n* pregnancy\n* medication sensitizing for light exposure (e.g. doxycycline)",{"count":131,"type":22},75,[25],"The LF-PODD study investigates the use of UVC (270nm) light in the prevention of surgical wound infections. Three devices are used in the study, two of which are actively producing UVC light (265 and 275 nm) and one device does not produce UVC light at all. The devices are outwardly completely identical and the devices are drawn for the research participants. Volunteers for neurosurgical procedures are selected for the study. Everyone participating in the study will be informed about the research and written consent will be requested. In the study, UVC light is focused on the surgical area at the beginning of the neurosurgical operation, during the operation, the device automatically dispenses UVC light into the air of the surgical area every 20 minutes, and at the end of the surgical procedure, the device delivers a single dose of UVC light to the surgical wound after closing the surgical wound. Study participants are monitored according to the standard treatment protocol and, in particular, the inflammation of the surgical wound is monitored. The results of the study are recorded and analysed using statistical methods.",[28],[136,137,138],"Surgical infection","Prevention","UVC","2026-05-13",{"date":141,"type":33},"2026-05-20",{"date":82,"type":22},{"date":144,"type":22},"2029-12-31",{"name":146,"class":40},"Ville Leinonen",{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":154,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100509247","european-study-of-prodromal-inph-100509247","NCT05910944","European Study of Prodromal iNPH","STOP iNPH","Inclusion criteria - Group 1 - prodromal iNPH\n\n* Brain imaging with both:\n\n  * Evans index \\> 0.3\n  * Callosal angle ≤ 90 º or:\n  * Disproportionately enlarged subarachnoid space hydrocephalus (DESH) - defined as: enlarged ventricles, dilated sylvian fissures and tight sulci at the high convexity.\n* Absence of symptoms or too mild symptoms to motivate shunt surgery according to local routine, and all of the following:\n\n  * Normal gait pattern, or slight disturbance of the gait pattern that is not considered to be caused by a disease in the central nervous system (CNS).\n  * Gait velocity (maximum gait speed), men ≥ 1.4 m\u002Fs; women ≥ 1.25 m\u002Fs.\n  * Rombergs test with eyes open \\> 60 seconds\n  * Mini Mental State Examination (MMSE) ≥ 27 or Montreal Cognitive Assessment (MoCA) ≥ 23\n* Informed consent\n\nExclusion criteria - Group 1 - prodromal iNPH\n\n* Contraindication for MRI\n* Other serious disease with expected survival less than three years\n* Other type of hydrocephalus:\n\n  * non-communicating hydrocephalus\n  * secondary communicating hydrocephalus\n  * suspected congenital hydrocephalus (severely enlarged ventricles, narrow sylvian fissures and normal non-compressed sulci at the high convexity or morphological findings consistent with PaVM18)\n* Anticoagulants in a dose that hinders lumbar puncture\n\nInclusion criteria - Group 2 - healthy controls\n\n• Age \\> 65 years\n\nExclusion criteria - Group 2 - healthy controls:\n\n* Imaging findings meet inclusion criteria of Group 1\n* Previously known relevant neurological disease\n* Pathological gait pattern with unknown reason.\n* MMSE \\\u003C 27 or MoCA \\\u003C 26.\n* Anticoagulants in a dose that hinders lumbar puncture\n\nInclusion criteria Group 3 symptomatic iNPH\n\n* iNPH diagnosis according to international guidelines.19\n* Age matched with the individual in Group 1 (+\u002F- 3 years)\n\nExclusion criteria Group 3 symptomatic iNPH\n\n* Previous stroke (clinical stroke, not only radiologically verified)\n* Other serious disease with expected survival less than three years",true,{"count":156,"type":22},140,"OBSERVATIONAL","To investigate if progression from prodromal into symptomatic NPH can be predicted from advanced neuroimaging, biomarkers in cerebrospinal fluid (CSF) and plasma and investigate the unknown mechanisms causing deterioration by investigating longitudinal changes in the above-mentioned variables. Three different cohorts with both asymptomatic and symptomatic patients as well as healthy controls will be investigated over time, both without intervention and before and after shunt surgery.",[160,28],"Normal Pressure Hydrocephalus",[162,57,163,164],"natural history","biomarkers","long term follow-up","2026-04-29",{"date":167,"type":33},"2026-04-30",{"date":169,"type":33},"2023-11-01",{"date":171,"type":22},"2035-12-31",{"name":173,"class":40},"Johan Virhammar",7,{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":17,"minAge":181,"maxAge":19,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":186,"conditions":187,"keywords":197,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":41},"100635064","phase-4-efficacy-and-cost-effectiveness-of-topical-vancomycin-powder-in-preventing-pediatric-ventriculoperitoneal-shunt-infections-across-different-etiologies-100635064","NCT07547826","Efficacy and Cost-Effectiveness of Topical Vancomycin Powder in Preventing Pediatric Ventriculoperitoneal Shunt Infections Across Different Etiologies","Inclusion Criteria:\n\nPatients will be enrolled in the study if they meet all the following criteria:\n\n* Age Range: Paediatric patients from birth (neonates) up to 18 years of age.\n* Indication: Patients undergoing primary (first-time) Ventriculoperitoneal (VP) shunt insertion.\n* Aetiology: Hydrocephalus due to congenital causes, post-haemorrhagic, or post-inflammatory origins.\n* Consent: Written informed consent provided by the parents or legal guardians.\n\nExclusion Criteria:\n\nTo ensure that the infection rate is strictly related to the surgical procedure and not to external chronic factors, patients with the following will be excluded:\n\n* Tumor-related Hydrocephalus: Due to the impact of malignancy, chemotherapy-induced immunosuppression, or potential radiotherapy on wound integrity.\n* Co-morbidities: Patients with Diabetes Mellitus, chronic renal failure, or known immunodeficiency disorders (to isolate paediatric physiological response).\n* Active Infection: Clinical or laboratory evidence of systemic sepsis or meningitis at the time of surgery.\n* Hypersensitivity: Known history of allergy to Vancomycin.\n* Revision Surgery: Patients undergoing shunt revision or replacement due to previous infection within the last 3 months.\n* Local Skin Issues: Active dermatitis or infection at any of the planned incision sites.\n* Complex Hydrocephalus: Patients requiring additional concurrent neurosurgical procedures (e.g., tumor biopsy, Chiari decompression, or cyst fenestration) to avoid prolonged operative time as a confounding risk factor for infection.\"","1 Day",{"count":183,"type":22},164,[185],"PHASE4","Objectives\n\n* Primary:\n* To measure the reduction in VP shunt infection rates using topical vancomycin powder.\n* Secondary:\n* To compare efficacy across different Etiological Strata (Congenital, Post-hemorrhagic, post-inflammatory).\n* To analyze the microbiological profile of failed cases.\n* To compare the \"Time-to-Infection\" and shunt survival rates between the study and control groups using Kaplan-Meier analysis.\n* To evaluate the cost-effectiveness of TVP compared to the standard management and historical AIC data",[28,188,189,190,191,192,193,194,195,196],"Ventriculoperitoneal Shunt Infection","Surgical Site Infection (SSI)","Cerebrospinal Fluid Shunt Infection","Pediatric Hydrocephalus","Hydrocephalus in Children","Hydrocephalus in Infants","Postoperative Complications","Prosthesis-Related Infections","Bacterial Infections and Mycoses",[198,199,200,188,201,202,203,204,205,206,207,208,209,210,211,212,213],"Topical Vancomycin Powder","Vancomycin Crystalline Powder","Biofilm Prevention","Congenital Hydrocephalus","Post-Hemorrhagic Hydrocephalus","Post-Meningitic Hydrocephalus","Cost-Effectiveness","Resource-Limited Settings","Pediatric Neurosurgery","Antibiotic Stewardship","Surgical Site Infection","Antibiotic-Impregnated Catheters","Cerebrospinal Fluid Shunt","Surgical Wound Infection","VP Shunt Infection","AIC","2026-04-17",{"date":216,"type":33},"2026-04-23",{"date":218,"type":22},"2026-05",{"date":220,"type":22},"2027-12",{"name":222,"class":40},"Assiut University",{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":233,"conditions":234,"keywords":255,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":266},"100571728","neurosurgical-outcome-network-100571728","NCT06724029","Neurosurgical Outcome Network","Neurosurgical Outcome Network Per la Predizione Dell'Outcome in Neurochirurgia","NEON","Inclusion Criteria:\n\n* Neuro-oncological pathology: supratentorial and subtentorial tumors, intra and extra axial tumors excluding the skull base (anterior, middle and posterior fossa; sellar and parasellar region)\n* Basicranial pathology: tumors originating from the anterior cranial fossa, middle cranial fossa and posterior cranial fossa, sellar region with or without supratentorial\u002Fparasellar development.\n* Vascular pathology: aneurysms, AVMs, cavernomas, other pathologies (Moyamoya disease, dural fistulas, nontraumatic hematomas)\n* Traumatic pathology: diffuse damage (nonvisible diffuse damage, diffuse damage, diffuse damage with edema, diffuse damage with shift) and focal damage (acute\u002Fsubacute\u002Fchronic subdural hematoma, extradural hematoma, subarachnoid hemorrhage, intraparenchymal hematoma, fractures); hydrocephalus. The inclusion criterion for chronic subdural hematoma is recent bleeding for TBI with CT finding of chronic subdural hematoma candidate for evacuation surgery.\n* Spinal pathology: degenerative cervical (anterior\u002Fposterior), myelopathic, and trauma pathology; instrumented, uninstrumented thoracolumbar pathology (disc pathology, canal pathology), and trauma pathology; oncologic spinal pathology.\n* Functional pathology: Parkinson's disease, spasticity, trigeminal neuralgia, craniofacial pain\u002Falgia, neuropathic pain, tremor, dystonias, obsessive compulsive disorder, drug-resistant epilepsies, depression. Normotensive hydrocephalus.\n* Peripheral nervous system pathology: peripheral nerve compression syndromes, peripheral nerve and plexus tumors, brachial plexus and peripheral nerve trauma (contusion and section)\n* Malformative pathology: Chiari malformation type 1 and craniostenoses including both those framed in malformative syndromes and those not framed in malformative syndromes (monosutural craniostenoses: trigonocephaly, plagiocephaly, scaphocephaly; multisutural craniostenoses). Malformative hydrocephalus.\n* For cognitive and psychological assessment: age 18 years or older; adequate understanding of Italian language; diagnosis of glioma, meningioma, vascular pathology, spinal pathology\n\nExclusion Criteria:\n\n* For cognitive and psychological assessment: patients with psychiatric diseases in history and\u002For taking psychotropic drugs; presence of overt cognitive decline (not due to the injury) in history; patients younger than 18 years old.",{"count":232,"type":22},4500,"The evaluation of neurosurgical outcomes varies from center to center, and the predictive factors that determine these outcomes are not fully known or shared. This study aims to assess outcomes and their predictors using measures agreed upon by the participating centers. Standardizing the evaluation of outcomes and predictors improves the quality of research, allows for data comparison, and facilitates a \"common language\" in routine clinical practice. Most importantly, it influences therapeutic decisions in various neurosurgical conditions. Clinically, the identified predictors can also be used during preoperative assessments to provide more precise guidance to patients undergoing surgery.",[235,236,237,238,239,240,241,242,103,28,243,244,245,246,247,248,249,250,251,252,160,253,254],"Aneurysms","Arteriovenous Malformations","Cavernomas","Skull Base Tumors","Moyamoya Disease","Dural Fistulas","Subdural Hematoma","Extradural Hematoma","Parkinson&Amp;#39;s Disease","Spasticity","Trigeminal Neuralgia","Craniofacial Pain","Neuropathic Pain","Tremor","Dystonias","Obsessive-compulsive Disorder","Drug-resistant Epilepsy","Depression","Tumors of Peripheral Nerves","Chiari Malformation Type 1",[256],"Neurosurgery Outcome Artificial Intelligence predictors","2026-03-25",{"date":259,"type":33},"2026-03-30",{"date":261,"type":33},"2022-12-05",{"date":263,"type":22},"2027-06",{"name":265,"class":40},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta",27,{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":17,"minAge":275,"maxAge":276,"enrollmentInfo":277,"targetDuration":4,"studyType":23,"phases":279,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":41},"100481284","evd-drainage-data-and-intracranial-pressure-icp-measurements-100481284","NCT05546996","EVD Drainage Data and Intracranial Pressure (ICP) Measurements","The Correlation Between FlowSense Flow Rate Measurements and: EVD Drainage Data and Intracranial Pressure (ICP) Measurements","RHAEOS","Inclusion Criteria:\n\n* Patients with one or more existing external ventricular drains (EVDs).\n\nExclusion Criteria:\n\n* Patients with no external ventricular drains (EVDs).","1 Year","21 Years",{"count":278,"type":22},24,[25],"Rhaeos, Inc. is initially targeting hydrocephalus, a life threatening condition caused by an abnormal accumulation of cerebrospinal fluid (CSF). Implantable shunts, the gold standard treatment, often fail, leading to multiple trips to the emergency room and repeat surgeries. There is no technology available today that can easily assess CSF flow in shunts wirelessly, bedside, and without capital equipment until now.\n\nFlowSense, is a wireless, noninvasive thermal flow sensor that can be mounted on a patient's neck overlying the shunt to detect the presence and magnitude of CSF. Similar in size to a bandage, it is composed of soft, silicone with no hard edges. Data is wirelessly transmitted to a custom designed mobile app. With FlowSense, monitoring of shunt function can occur in clinics, in-patient settings, and emergency departments, thereby reducing unnecessary imaging, hospital length of stay, and readmission costs.",[28],[283,28],"EVD shunt","2026-03-23",{"date":257,"type":33},{"date":287,"type":33},"2023-07-11",{"date":289,"type":22},"2027-01-30",{"name":291,"class":40},"Baylor College of Medicine",{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":302,"conditions":303,"keywords":306,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":321},"100553501","shunt-dependency-after-asah---role-of-early-hyperglycaemia-in-csf-and-blood-100553501","NCT06486909","Shunt-dependency After aSAH - Role of Early Hyperglycaemia in CSF and Blood","Shunt-dependency After Aneurysmal Subarachnoid Haemorrhage - the Role of Early Hyperglycaemia in Cerebro-spinal Fluid and Blood","HCP-Glc","Inclusion Criteria:\n\n* 18 years old and older\n* Hospital admission due to an aneurysmal subarachnoid haemorrhage (radiological confirmation needed)\n\nExclusion Criteria:\n\n* Younger than 18 years old\n* Non-aneurysmal subarachnoid haemorrhage (eg. trauma, perimesencephalic subarachnoid haemorrhage, mycotic or flow-associated aneurysms)\n* Previous enrolment into the current study",{"count":301,"type":22},160,"The goal of this study is to confirm the association of early increased glucose levels in cerebro-spinal fluid (CSF) and ventriculo-peritoneal-shunt (VPS)-dependency also evaluating the influence of blood glucose on VPS dependency in patients suffering from an aneurysmal subarachnoid haemorrhage (aSAH). The main questions we aim to answer are:\n\n* Is there an association of glucose levels on VPS dependency in patients requiring extra-ventricular-drain (EVD) placement for aSAH?\n* In addition, if there is, what is the influence the course of glucose levels has on VPS dependency?\n\nGlucose levels in CSF and serum will be measured on admission, or in case of CSF, upon EVD placement. Glucose in CSF will then be measured every day until EVD removal together with serum glucose. Follow-up will be conducted in person after 3 and 6 months.",[304,305,28],"Aneurysm, Ruptured","Hyperglycemia",[307,308,309,310,311],"aneurysmal subarachnoid haemorrhage","hyperglycaemia","hydrocephalus","ventriculo-peritoneal shunt","extra-ventricular drain","2026-03-17",{"date":314,"type":33},"2026-03-18",{"date":316,"type":33},"2024-03-26",{"date":318,"type":22},"2028-09",{"name":320,"class":40},"Isabel Hostettler",3,{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":154,"sex":17,"minAge":329,"maxAge":330,"enrollmentInfo":331,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":333,"conditions":334,"keywords":338,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":321},"100255235","nirs-monitoring-in-premature-infants-100255235","NCT02601339","NIRS Monitoring in Premature Infants","Beside Monitor of Cerebral Metabolism in Premature Infants With Intraventricular Hemorrhage and Post-Hemorrhagic Hydrocephalus","1. GM-IVH group:\n\n   Inclusion criteria for GM-IVH group: born at gestational age (GA) 24-32 weeks; \\\u003C 3 months old corrected-GA (cGA) at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks post-menstrual age (PMA). Grade I-III IVH diagnosed by clinical cranial ultrasound or magnetic resonance imaging (MRI).\n\n   Exclusion criteria for GM-IVH group: chromosomal abnormalities known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; congenital hydrocephalus; brain lesions that affect cerebral brain metabolism, other than GMH-IVH; central nervous system (CNS) infection.\n2. PHH group:\n\n   Inclusion criteria for PHH group: born at gestational age (GA) 24-37 weeks \\\u003C 3 months old cGA at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks age (PMA). PHH diagnosed by clinical cranial ultrasound or MRI.\n\n   Exclusion criteria for PHH group: chromosomal abnormalities known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; congenital hydrocephalus; brain lesions that affect cerebral brain metabolism, other than IVH-PHH; CNS infection. Implanted devices or other devices that preclude the use of MRI.\n3. HC group:\n\n   Inclusion criteria for HC group: born at gestational age (GA) 24-32 weeks; \\\u003C 3 months old cGA at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks age (PMA); Apgar \\>7 at 5 min.\n\n   Exclusion criteria for HC group: any clinical indication of brain injury or congenital brain malformation; chromosomal abnormality known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; CNS infection.\n4. VC group:\n\nInclusion criteria for VC group: \\\u003C 12 months old cGA at first measure or eligible for measurement within 1 year after the infant reaches 40 weeks age (PMA). Symptomatic hydrocephalus of any etiology or at high risk of developing hydrocephalus of any etiology, except post-hemorrhagic etiology; characterized by abnormal rate of head growth and full anterior fontanelle. Ventricular enlargement diagnosed by ultrasonography or MRI; no signs of IVH.\n\nExclusion criteria for VC group: known or suspected metabolic disorder or neoplasm; critical congenital heart disease; CNS infection. Implanted devices or other devices that preclude the use of MRI.","0 Months","12 Months",{"count":332,"type":22},70,"This study uses frequency domain near-infrared spectroscopy coupled with diffuse correlation spectroscopy (FDNIRS-DCS) technology for monitoring cerebral blood flow (CBF) and cerebral oxygen metabolism (CMRO2) at the bedside for newborns with germinal matrix-intraventricular hemorrhage (GM-IVH) and\u002For post-hemorrhagic hydrocephalus (PHH) in comparison to newborns with hydrocephalus of a different etiology (VC) and healthy controls (HC). We hypothesize that baseline cerebral metabolic dysfunction is a better biomarker for GM-IVH and PHH severity and response to PHH treatment.\n\nThis is a Boston Children's Hospital (BCH)-institutional review board(IRB) approved, multi-site study that includes collaboration with Brigham and Women's Hospital (BWH) and Beth Israel Deaconess Medical Center (BIDMC). Pei-Yi Lin receives funding from The National Institute of Health (NIH) to support the study and is the overall principal Investigator (PI) overseeing the study.",[335,336,337,28],"Hemorrhage","Premature Infants","Newborn",[339],"spectroscopy, Near-Infrared","2026-03-16",{"date":314,"type":33},{"date":343,"type":33},"2015-04",{"date":345,"type":22},"2026-12",{"name":347,"class":40},"Boston Children's Hospital",{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":23,"phases":357,"briefSummary":358,"conditions":359,"keywords":360,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":368,"locationsCount":41},"100629765","flow-detection-in-open-and-closed-shunt-valve-periods-100629765","NCT07478926","Flow Detection in Open and Closed Shunt Valve Periods","Detection of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Flow Detection Device During Open and Closed Shunt Periods","Inclusion Criteria:\n\nInclusion and Exclusion Criteria for Roll-In Subjects Inclusion criteria\n\n* Existing ventricular CSF shunt with an available \"virtual off\" setting which can be programmed noninvasively\n* Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device\n* Signed informed consent by subject or a parent or legal guardian, health care agent, or surrogate decision maker (according to local statutes)\n* Subject-reported or documented history of successful valve adjustment(s)\n\nInclusion and Exclusion Criteria for Main Study Subjects\n\nInclusion criteria\n\n* Existing ventricular CSF shunt\n* Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device\n* Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)\n\nSubjects with planned \"virtual off\" measurement:\n\n-Existing ventricular CSF shunt with an available \"virtual off\" setting which can be programmed noninvasively\n\nSubjects with planned adjustment to the \"virtual off\" setting only:\n\n-Subject-reported or documented history of successful valve adjustment(s)\n\nExclusion Criteria:\n\nExclusion criteria\n\n* Presence of more than one distal shunt catheter in the study device measurement region\n* Presence of an interfering open wound or edema in the study device measurement region\n* Shunt is difficult to palpate, or the shunt depth at the device measurement location is deeper than 5 mm from the skin surface via ultrasound measurement\n* Shunt valve is set to an opening pressure of \\>= 300 mm H2O, or the shunt system is otherwise set to substantially prevent shunt flow (e.g. Certas Plus valve programmed to a setting of 8 or a ligated shunt)\n* Investigator judges that the subject is likely to be shunt independent (e.g. does not require a functional shunt for management of hydrocephalus)\n* Subject has more than one intact and presumed functional distal catheter\n* Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives\n* Subject-reported new or worsening symptoms of a possible shunt malfunction in the prior 7 days\n* Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject\n* Prior enrollment in this study\n* Participation in any other investigational procedural, pharmaceutical, and\u002For device study that may influence the collection of valid data under this study\n\nExclusion Criteria for Main Study Subjects Exclusion criteria\n\n* Presence of more than one distal shunt catheter in the study device measurement region\n* Presence of an interfering open wound or edema in the study device measurement region\n* Shunt is difficult to palpate, or the shunt depth at the device measurement location is deeper than 5 mm from the skin surface via ultrasound measurement\n* Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives\n* Subject-reported new or worsening symptoms of a possible shunt malfunction in the prior 7 days\n* Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject\n* Prior enrollment in this study\n* Participation in any other investigational procedural, pharmaceutical, and\u002For device study that may influence the collection of valid data under this study\n* Previous participation in a Rhaeos clinical study in which the study device (current generation) was used to acquire measurement data\n\nSubjects with planned \"valve normal\" measurements:\n\n* Shunt system is set to substantially prevent shunt flow (e.g. ligated shunt)\n* Investigator judges that the subject is likely to be shunt independent (e.g. does not require a functional shunt for management of hydrocephalus)\n* Subject has more than one intact and presumed functional distal catheter",{"count":356,"type":22},55,[25],"This study is evaluating a new, noninvasive device designed to detect whether cerebrospinal fluid (CSF) is flowing through a surgically implanted shunt. CSF shunts are commonly used to treat hydrocephalus, but it can be difficult to tell whether a shunt is working properly without invasive testing or imaging that does not directly measure flow.\n\nThe study device is a small, wireless sensor placed on the skin over the shunt tubing, typically near the collarbone. It uses gentle, controlled warmth to measure temperature changes that indicate whether fluid is flowing inside the shunt. The device does not break the skin and does not change a participant's medical care.\n\nThis study will enroll children and adults who already have a CSF shunt and who do not have new or worsening symptoms of shunt malfunction. All participants will have a measurement taken while their shunt valve is at its usual prescribed setting. Some participants with programmable shunt valves will also have a second measurement taken after their valve is temporarily adjusted to a setting intended to stop or greatly reduce flow (\"virtual off\"). After this measurement, the valve will be returned to its prescribed setting.\n\nThe study device results will not be shown to participants or their medical providers and will not be used to make treatment decisions. The goal of the study is to determine how well the device can distinguish between shunts that are allowing flow and those that are not.\n\nParticipants will be monitored for a short period after device use and, if applicable, after any valve adjustment. The main risks of participation are mild skin irritation from the adhesive or temporary symptoms related to valve adjustment. Participants are not expected to receive a direct medical benefit, but the information gained may help improve future diagnosis of shunt function.",[28],[309,361,55,362],"wearable","valve","2026-03-12",{"date":314,"type":33},{"date":366,"type":33},"2026-01-27",{"date":66,"type":22},{"name":68,"class":69},{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":377,"conditions":378,"keywords":379,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":41},"100626999","crystallization-of-la-and-adjuvant-mixtures-in-cerebrospinal-fluid-100626999","NCT07442929","Crystallization of LA and Adjuvant Mixtures in Cerebrospinal Fluid","Crystallization of Local Anesthetic and Adjuvant Mixtures in Cerebrospinal Fluid as a Model for Interstitial Space - a Semiquantitative in Vitro Trial","Inclusion Criteria:\n\n* Patients with normal pressure hydrocephalus scheduled for elective lumbar puncture.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years",{"count":77,"type":22},"Different mixtures of local anesthetics or local anesthetics with adjuvants that are known to precipitate in vitro are tested in human cerebrospinal fluid (CSF). CSF is gained from patients with normal pressure hydrocephalus scheduled for elective lumbar puncture. Patients signed an ICF for leftover samples.\n\nCSF will be assessed for pH values at different timepoints (t0-t3; 0 to 60 minutes).\n\nIn a second step six commonly used mixtures of LA with LA or LAs with adjuvants will be mixed using the following mixture ratios: ropivacaine 0.75% + lidocaine 2% (ratio 1:1), ropivacaine 0,75% + mepivacaine 2% (ratio 1:1), ropivacaine 0.75% + chloroprocaine 2% (ratio 1:1), lidocaine 2% + sodium bicarbonate 8.4% (ratio 1:0.1), ropivacaine 0.75% + lidocaine 2% + sodium bicarbonate 8.4% (ratio 1:1:0.1) and ropivacaine 0.75% + dexamethasone (1.5:1). The used mixture ratios are inspired by commonly mixtures described in the current literature and have been proven to precipitate in vitro. For every mixture, a Grade of Crystallisation will be determined at baseline without CSF and then at t0 (immediately) to t3 (60 minutes) every 15 minutes.",[28],[380,381,57,382,383,384,385],"local anesthetics;","local anesthetic mixtures","in vitro","crystallization","pH","adjuvants","2026-02-26",{"date":388,"type":33},"2026-03-02",{"date":390,"type":33},"2025-09-01",{"date":392,"type":22},"2026-09-01",{"name":394,"class":40},"Medical University Innsbruck",{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":405,"conditions":406,"keywords":414,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":425},"100544420","comind-early-feasibility-study-100544420","NCT06368648","CoMind Early Feasibility Study","An Early Feasibility Study for the Development of a Model to Non-Invasively Estimate Intracranial Pressure (ICP) and New Metrics of Cerebral Autoregulation (CAR) Using the CoMind One EFS Device","CoMind EFS","Inclusion Criteria:\n\n1. Male or female sex at birth, and aged 18 years or older on the date of enrollment.\n2. Receiving continuous invasive ICP monitoring (Bolt or EVD) as part of standard care.\n3. Invasive ICP monitor catheter penetrating the parenchyma or ventricles.\n4. Receiving continuous invasive ABP monitoring as part of standard care.\n\nExclusion Criteria:\n\n1. Presence of any implant (cosmetic or otherwise) in the frontal bone in such proximity to the CoMind One EFS Sensor that they might physically touch.\n2. Open wounds on the forehead such that CoMind One EFS Sensor cannot be safely placed over an area of intact skin\n3. Presenting with radiographic evidence of a non-intact skull at the recording site on admission.\n4. If patient is enrolled in an intervention\u002Fstudy that may interfere with SoC ICP measurements or the CoMind One EFS device measurement then the patient is ineligible.\n5. Patients with decompressive craniectomy will be excluded unless a CoMind One EFS recording can be made from intact skull.",{"count":404,"type":22},581,"The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around the brain from the outside (this pressure is called intracranial pressure or ICP). Monitoring and managing ICP is an important part of care for patients with conditions such as Traumatic Brain Injury (TBI). However, the current way of measuring ICP requires surgery to drill a hole into the skull, and therefore can introduce additional risks such as infections and pain.\n\nRecent research has shown it may be possible to measure ICP without needing surgery. This technology is in development, but large amounts of data is required to build these new devices.\n\nThrough collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head, the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP.",[109,407,408,409,410,411,28,412,413],"Intracranial Pressure Changes","Traumatic Brain Injury","Intracerebral Hemorrhage","Encephalitis","Encephalopathy","Stroke","Autoregulation",[109,408,415],"Cerebral Autoregulation","2026-02-12",{"date":418,"type":33},"2026-02-13",{"date":420,"type":33},"2024-11-27",{"date":422,"type":22},"2026-11",{"name":424,"class":69},"CoMind Technologies Limited",14,{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":433,"targetDuration":4,"studyType":23,"phases":435,"briefSummary":437,"conditions":438,"keywords":440,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":41},"100439396","phase-1-prophylactic-antibiotics-useful-with-antibiotic-impregnated-external-ventricular-drains-evds-100439396","NCT05001750","Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?","Are Long Term Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?","Inclusion Criteria:\n\n* patients over the age of 18 years\n* patients diagnosed with a subarachnoid hemorrhage, intracerebral hemorrhage, or acute ischemic stroke who require an EVD for management of their underlying condition. In certain cases (a small minority), an EVD must be replaced due to failure (i.e., blood clot interrupting flow). In such cases, patients will be re-dosed with antibiotics prior to catheter exchange in typical fashion and continue in their previously randomized treatment group\n\nExclusion Criteria:\n\n* patients who were on antibiotics within the week prior to admission\n* patients with leukopenia (\\\u003C5000) at baseline\n* patients with signs of meningitis, ventriculitis or any other infection at presentation\n* patients who are pregnant or prisoners\n* patients aged \\\u003C 18 years old",{"count":434,"type":22},84,[436],"PHASE1","The principal objective of this study is to compare the incidence of ventriculostomy related infections (VRIs) in patients who receive twenty-four hours of antibiotics, beginning no more than sixty minutes prior to EVD placement, to the incidence of VRIs in patients who also receive a pre-procedural dose of antibiotics with continued dosing of antibiotics for the duration of the external ventricular drain (EVD). At this time, the duration of prophylactic antibiotic use with antibiotic impregnated EVDs is unknown.",[103,409,439,28],"Ventriculitis, Cerebral",[441,409,442,28],"Subarachnoid hemorrhage","Ventriculitis","2026-01-29",{"date":445,"type":33},"2026-02-02",{"date":447,"type":33},"2021-06-14",{"date":449,"type":22},"2026-06",{"name":451,"class":40},"Montefiore Medical Center",{"id":453,"slug":454,"hasResults":12,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":458,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":460,"targetDuration":18,"studyType":157,"phases":4,"briefSummary":462,"conditions":463,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":41},"100622196","ventriculostomy-associated-infections-lactic-focus-on-csf-lactate-and-sampling-site-100622196","NCT07380477","VentricuLostomy AssoCiaTed InfeCtions (LACTIC): Focus on CSF Lactate and Sampling Site","CSF Lactate and Ventriculostomy Associated Infections in Patients With Acute Brain Injury - a Prospective, Observational Cohort Study.","LACTIC","Inclusion Criteria:\n\n* Age \\>18 years\n* EVD in situ\n* Admission to the neuro-ICU or neurosurgical step-down unit at Rigshospitalet, Denmark\n* Diagnosis of acute brain injury categorized as traumatic brain injury, subarachnoid haemorrhage, intracranial haemorrage, intraventricular haemorrhage\n\nExclusion Criteria:\n\n* Patient or closest relatives do not understand written and spoken Danish or English\n* Patients transferred to Rigshospitalet with an EVD\n* Patients with brain injury due to existing brain infection (e.g., meningitis, intracranial empyema or abscess, encephalitis)\n* Patients with existing ventriculoperitoneal or ventriculoatrial shunt at the time of admission\n* Patients with primary or secondary brain cancer\n* Patients died or in palliative care",{"count":461,"type":22},148,"This observational study involving patients with acute brain injury undergoing treatment with an external ventricular drain consists of three subprojects, aiming to:\n\n1. investigate various biomarkers, with a primary focus on the development of cerebrospinal fluid lactate in relation to ventriculostomy-associated infection;\n2. compare proximal and distal sample results obtained from an external ventricular drain;\n3. describe the natural progression of various biomarkers in blood and cerebrospinal fluid following acute brain injury.",[464,28,107,465],"Acute Brain Injury","External Ventricular Drainage Associated Infection","2026-01-28",{"date":445,"type":33},{"date":469,"type":33},"2025-01-15",{"date":471,"type":22},"2029-10-01",{"name":473,"class":40},"Rigshospitalet, Denmark",{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":481,"targetDuration":483,"studyType":157,"phases":4,"briefSummary":484,"conditions":485,"keywords":486,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":498},"100419814","safety-and-performance-of-the-polaris-24-adjustable-valve-system-in-hydrocephalus-patients-treatment-100419814","NCT04746625","Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment","SAPPHYRE","Inclusion Criteria:\n\n* Patient implanted with the Polaris® 24 adjustable valve system for the following reasons:\n\n  * Primo implant of a valve shunt-based derivation system, or as a\n  * Replacement of another valve -based shunt system, or\n  * Endoscopic ventriculostomy (EVT) failure\n* Patient having given his\u002Fher informed consent prior to inclusion in this study, as per local regulations\n\nExclusion Criteria:\n\n* Confirmed or suspected infections along the length of the shunt (meningitis, ventriculitis, peritonitis, septicemia or bacteremia) or any infection present in any part of the body\n* Patient on anticoagulant therapy, or presenting with bleeding diathesis, or with haemorrhagic CSF, as the presence of blood in the system could lead to an obstruction in the system\n* Ventriculo-atrial shunts in patient suffering from congenital cardiopathies or other malformations of the cardio-pulmonary system",{"count":482,"type":22},126,"5 Years","The SAPPHYRE study is an ambispective (retrospective and prospective) PMCF study with the objective to evaluate the safety and performance of the Polaris® 24 adjustable valve system in the treatment of 126 patients with hydrocephalus.",[28],[28,487,488,489],"Adjustable valve","Polaris 24","Cerebrospinal fluid","2026-01-23",{"date":366,"type":33},{"date":493,"type":33},"2021-06-04",{"date":495,"type":22},"2033-06",{"name":497,"class":69},"Sophysa",2,{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":505,"enrollmentInfo":4,"targetDuration":4,"studyType":506,"phases":4,"briefSummary":507,"conditions":508,"keywords":4,"overallStatus":513,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":516,"locationsCount":498},"100310906","expanded-access-protocol-umbilical-cord-blood-infusions-for-children-with-brain-injuries-100310906","NCT03327467","Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries","Under this protocol, participants may be eligible for infusion of autologous, sibling, and\u002For unrelated donor CB cells (Duke only). Some eligibility criteria vary based on CB source. For all participants, eligibility is predicated on the availability of a qualifying CB unit To be eligible, patients must:\n\nInclusion Criteria:\n\n1. Age at Consent:\n\n   1. Autologous: 0-26 years\n   2. Sibling: 6 months - 26 years\n   3. Unrelated Donor (Duke only): 6 months - 26 years\n2. Diagnosis\n\n   1. Autologous and Sibling: Cerebral palsy, Hypoxic brain injury, Stroke, Hydrocephalus, Apraxia (without autism), Other brain injury\n   2. Unrelated Donor (Duke only): Motor impairment secondary to: Hypoxic brain injury, Periventricular leukomalacia, Stroke\u002Fbleed, Congenital hydrocephalus\n3. Functional Status:\n\n   1. Autologous and Sibling: See exclusion criteria\n   2. Unrelated Donor (Duke only): GMFCS level I-IV (age ≥2)\n4. No clinically significant abnormalities in blood counts and basic chemistries for age.\n5. Absolute Lymphocyte Count:\n\n   * 1200 for African American participants\n   * 1500 for all other participants\n6. Availability of a qualified autologous or Sibling CB Unit\n\n   1. Autologous or Sibling: available\n   2. Unrelated Donor (Duke only): N\u002FA\n7. Written informed consent obtained from the parent or legal guardian.\n\nExclusion Criteria:\n\n1. Documented HIV or Hepatitis or other disease transmittable through the blood.\n2. A cord blood unit that fails to meet specifications\n3. Refusal of consent\n4. Uncontrolled seizure disorder\n5. Uncontrolled infection\n6. Diagnosed with a genetic or metabolic disorder related to the neurologic condition\n7. History of an immune deficiency\n8. History of treatment with chemo or immunosuppressive therapy\n9. History of previous allogeneic cell therapy outside of participation in a Duke clinical trial\n10. Need for mechanical ventilation or chronic O2 support\n11. Unstable airway\n12. Eligible for an active clinical trial of cellular therapy at Duke. If previously enrolled on another Duke cell therapy protocol the participant may still be considered for enrollment on this study after the follow-up period for the clinical trial is completed.\n13. Cerebral palsy secondary to infection, congenital or otherwise, without another known cause\n14. Pregnant or breastfeeding\n15. Treated with autologous cellular therapy through a non-intravenous route (ie. intrathecally) within one year prior to enrollment.\n\nUmbilical Cord Blood Criteria\n\nParticipant enrollment is dependent on the availability of a banked unit of autologous or sibling CB that has been stored at a private or public bank, or, if enrolling at Duke, availability of a publicly banked unrelated donor unit. Units must meet the following criteria:\n\nPrecryopreservation:\n\n1. TNCC ≥2x107\u002Fkg\n2. Sterility cultures performed and negative\n3. Viability ≥70%\n4. At least haploidentical HLA match for sibling units and at least a 4\u002F6 HLA match for unrelated donor units\n5. Donor screening testing performed and negative\n\nCBU Test sample\n\n1. Segment or test vial available\n2. Identity confirmed via HLA typing of test sample and donor\n3. Viability testing recommended, but not required","26 Years","EXPANDED_ACCESS","This protocol is designed to enable access to intravenous infusions of banked umbilical cord blood (CB), that is thawed and not more than minimally manipulated, for children with various brain disorders. Children with cerebral palsy, congenital hydrocephalus, apraxia, stroke, hypoxic brain injury and related conditions will be eligible if they have normal immune function and do not qualify for, have previously participated in, or are unable to participate in an active cell therapy clinical trial at Duke Medicine. For the purpose of this protocol the term children refers to patients less than 26 years of age. Cord blood is administered as a cellular infusion without prior treatment with chemotherapy or immunosuppression. The mechanism of action is through paracrine signaling of cord blood monocytes inducing endogenous cells to repair existing damage.",[509,28,510,511,512],"Cerebral Palsy","Apraxia of Speech","Hypoxia Ischemia, Cerebral","Drowning; Anoxia","AVAILABLE","2026-01-22",{"date":490,"type":33},{"name":517,"class":40},"Joanne Kurtzberg, MD",{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":154,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":525,"targetDuration":4,"studyType":23,"phases":527,"briefSummary":528,"conditions":529,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":41},"100370167","mr-evaluation-of-cerebrospinal-fluid-csf-dynamics-100370167","NCT04099823","MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics","MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics and Association of Intracranial CSF Flow With Brain Function","Inclusion Criteria:\n\n* A healthy control will be defined as an otherwise healthy person who does not have a medical condition that affects brain function or have problems with concentration, memory, balance, or coordination.\n* Patients who have a suspected diagnosis of altered CSF dynamics including but not limited to normal pressure hydrocephalus will be referred to Dr. Cogswell by their care team to be included in the study. Conditions of altered CSF dynamics include obstructive and non-obstructive hydrocephalus and may be associated with headaches and\u002For decreased cognitive function.\n* Similarly, patients with impaired cognitive function including but not limited to Alzheimer's disease will be referred to Dr. Cogswell by their care team to be included in the study.\n\nExclusion Criteria:\n\n* Subjects with non-MRI compatible devices\n* required sedation\n* women who may be pregnant will be excluded.\n* The first 10 subjects with normal pressure hydrocephalus will not have previously been shunted.",{"count":526,"type":22},50,[25],"The Researchers are trying to test a MR imaging method for detection of Cerebral Spinal Fluid (CSF) flow in the brain to help diagnosis and better understand diseases that affect brain function.",[28,530],"Alzheimer Disease","2026-01-02",{"date":533,"type":33},"2026-01-06",{"date":535,"type":33},"2019-10-31",{"date":537,"type":22},"2027-01",{"name":539,"class":40},"Mayo Clinic",{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":17,"minAge":547,"maxAge":548,"enrollmentInfo":549,"targetDuration":4,"studyType":23,"phases":550,"briefSummary":551,"conditions":552,"keywords":554,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":498},"100577355","light-therapy-device-for-neonatal-intraventricular-hemorrhage-grade-3-and-4-100577355","NCT06797219","Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4","EFIL","Inclusion Criteria:\n\n* neonates with intraventricular hemorrhage grade 3 or 4 less than 1 month old.\n\nExclusion Criteria:\n\n* neonates without IVH grade 3\u002F4 or older than 1 month.","0 Days","1 Month",{"count":278,"type":22},[25],"The primary purpose of this study is to serve as a pilot study of the EFIL device treatment feasibility of IVH grades 3,4 to guide development of a larger trial. Primary outcomes will assess the following: safety of intervention, recruitment and consent process, acceptability of intervention by parents, retention rates, selection of most appropriate outcome measures, provide sample size estimates for a larger trial, increase the researchers\\' experience with the study intervention. A complete list of objectives and aims are listed under \"Objectives\". This study hopes to treat 12-24 neonates using 650nm light of irradiance 10mW\u002Fcm2 for 5 minutes twice a day each day for 12 days. We will also call the parents at 6 months and 12 months to track developmental milestones.",[553,28],"Intraventricular Hemorrhage of Prematurity",[555,556,557,558],"low level laser therapy","neonate","developmental milestones","intraventricular hemorrhage","2025-07-16",{"date":561,"type":33},"2025-07-22",{"date":563,"type":33},"2025-02-25",{"date":565,"type":22},"2028-07-31",{"name":567,"class":40},"Rutgers, The State University of New Jersey",{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":17,"minAge":483,"maxAge":276,"enrollmentInfo":575,"targetDuration":4,"studyType":23,"phases":577,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":41},"100596834","assessment-of-csf-shunt-flow-during-activities-of-daily-living-and-sleep-with-a-thermal-measurement-device-100596834","NCT07050628","Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device","Long-Term Tracking of Fluid Dynamics in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device During Activities of Daily Living Including Sleep","Inclusion Criteria:\n\n1. Existing ventricular CSF shunt\n2. (Cohort A) A history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure\n3. (Cohort B) A shunt revision in the previous 7 days and the investigator judges that the patient will likely be discharged within 4 days of the enrollment date\n4. Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device\n5. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)\n6. Subject is at least 5 years old but \\\u003C 22 years old\n\nExclusion Criteria:\n\n1. Shunt is not palpable or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation\n2. Presence of an interfering open wound or edema in the study device measurement region\n3. Subject-reported history of serious adverse skin reactions to silicone-based adhesives\n4. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable\n5. Investigator judges that the subject is unlikely to successfully take reliable measurements at home\n6. Investigator judges that the subject\u002Fsubject's caretaker would not be able to successfully place the device without assistance\n7. Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject\n8. Prior enrollment in this study\n9. Participation in any other investigational procedural, pharmaceutical, and\u002For device study that may influence the collection of valid data under this study",{"count":576,"type":22},20,[25],"This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during activities of daily living and sleep",[28],"2025-06-25",{"date":582,"type":33},"2025-07-03",{"date":584,"type":22},"2025-07",{"date":586,"type":22},"2025-12",{"name":68,"class":69},{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":594,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":17,"minAge":181,"maxAge":596,"enrollmentInfo":597,"targetDuration":4,"studyType":23,"phases":599,"briefSummary":601,"conditions":602,"keywords":603,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":618},"100376161","phase-3-hcrn-endoscopic-versus-shunt-treatment-of-hydrocephalus-in-infants-100376161","NCT04177914","HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants","Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants","ESTHI","Inclusion Criteria:\n\n1. Corrected age \\\u003C104 weeks and 0 days,\n\n   AND\n2. Child is ≥ 37 weeks post menstrual age,\n\n   AND\n3. Child must have symptomatic hydrocephalus, defined as:\n\n   Ventriculomegaly on MRI (frontal-occipital horn ratio (FOR) \\>0.45, which approximates \"moderate ventriculomegaly\"), and at least one of the following:\n   * Head circumference \\>98th percentile for corrected age with either bulging fontanelle or splayed sutures\n   * Upgaze paresis\u002Fpalsy (sundowning)\n   * CSF leak\n   * Papilledema\n   * Tense pseudomeningocele or tense fluid along a track\n   * Vomiting or irritability, with no other attributable cause\n   * Bradycardias or apneas, with no other attributable cause\n   * Intracranial pressure (ICP) monitoring showing persistent elevation of pressure with or without plateau waves\n\n   AND\n4. No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and\u002For external ventricular drains permissible)\n\nExclusion Criteria:\n\n1. Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR\n2. Anatomy not suitable for ETV+CPC or anteriorly placed ventriculoperitoneal shunt defined as:\n\n   * Moderate to severe prepontine adhesions on steady state free precession (SSFP) or T2 weighted fast (turbo) spin echo (FSE\u002FTSE) MRI, which includes the following sequences: FIESTA, FIESTA-C, TrueFISP, CISS, Balanced FFE (bFFE), CUBE, SPACE, VISTA, IsoFSE, and 3D MVOX\n   * Closure of one or both foramina of Monro\n   * Thick floor of third ventricle (≥ 3mm)\n   * Narrow third ventricle (\\\u003C5mm)\n   * Presence of scalp, bone, or ventricular lesions that make placement of an anterior shunt impracticable; OR\n3. Underlying condition with a high chance of mortality within 12 months; OR\n4. Hydrocephalus with loculated CSF compartments; OR\n5. Peritoneal cavity not suitable for distal shunt placement; OR\n6. Active CSF infection; OR\n7. Hydranencephaly; OR\n8. Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to the initial first-time permanent procedure for the treatment of hydrocephalus.","104 Weeks",{"count":598,"type":22},176,[600],"PHASE3","Hydrocephalus is a potentially debilitating neurological condition that primarily affects babies under a year of age and has traditionally been treated by inserting a shunt between the brain and the abdomen. A newer endoscopic procedure offers hope of shunt- free treatment that may reduce complications over a child's life, but it is not clear if the endoscopic procedure results in similar intellectual outcome as shunt. Therefore, the investigators propose a randomized trial to compare intellectual outcome and brain structural integrity between these two treatments, to help families make the best treatment decision for their baby.",[28],[28,604,605,606,607,608],"Infants","Ventriculoperitoneal Shunt","ETV+CPC","endoscopic third ventriculostomy","choroid plexus cauterization","2025-06-05",{"date":611,"type":33},"2025-06-11",{"date":613,"type":33},"2020-07-21",{"date":615,"type":22},"2027-08-31",{"name":617,"class":40},"University of Utah",21,{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":17,"minAge":626,"maxAge":627,"enrollmentInfo":628,"targetDuration":629,"studyType":157,"phases":4,"briefSummary":630,"conditions":631,"keywords":632,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":4},"100593185","relationship-between-hydrocephalus-and-endolymphatic-hydrops-100593185","NCT07003152","Relationship Between Hydrocephalus and Endolymphatic Hydrops","Prevalence of Endolymphatic Hydrops Among Patients With Hydrocephalus","Inclusion Criteria: Patients will be diagnosed with hydrocephalus through the neurosurgery department of the same hospital,\n\nExclusion criteria:\n\n* History of ear diseases\n* History of DM or Hypertension\n* History of Ototoxic drug intake.\n* Congenital anomalies of the auricle or external auditory meatus.\n* History of hereditary hearing loss in the family\n* History of noise exposure\n* Other neurological problems apart from hydrocephalus\n\nExclusion Criteria:\n\n\\-","20 Years","60 Years",{"count":576,"type":22},"3 Months","The goal of this observational study is to assess the prevalence of endolymphatic hydrops in patients with hydrocephalus and assess the auditory functions in patients with hydrocephalus including male and female with 20-60 year age groups. it aims to assess the prevalence of endolymphatic hydrops in patients with hydrocephalus and to assess the auditory functions in patients with hydrocephalus",[28],[633],"Hydrocephalus, endolymphatic hydrops","2025-06-03",{"date":636,"type":33},"2025-06-04",{"date":638,"type":22},"2025-07-01",{"date":640,"type":22},"2026-02-01",{"name":39,"class":40},{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":4,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":17,"minAge":649,"maxAge":650,"enrollmentInfo":651,"targetDuration":4,"studyType":23,"phases":653,"briefSummary":654,"conditions":655,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":662,"locationsCount":41},"100592682","assessment-of-csf-shunt-flow-and-headaches-with-a-thermal-measurement-device-100592682","NCT06996600","Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device","Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in People With Chronic Headaches","Inclusion Criteria:\n\n1. Existing ventriculoperitoneal CSF shunt\n2. Subject experiencing ongoing headaches including at least 15 headache days per month for the past 3 months\n3. Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device\n4. Available for remote and in-person follow-up during the 30-day measurement period\n5. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)\n6. Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English\n7. Subject is at least 6 years old but not more than 80 years old\n\nExclusion Criteria:\n\n1. Presence of more than one distal shunt catheter in the study device measurement region\n2. Shunt is not palpable due to depth or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation\n3. Presence of an interfering open wound or edema in the study device measurement region\n4. Subject-reported history of serious adverse skin reactions to silicone-based adhesives\n5. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable\n6. Investigator judges that the subject is unlikely to successfully take reliable measurements at home\n7. Investigator judges that the subject\u002Fsubject's caretaker would not be able to successfully place the device without assistance\n8. Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject\n9. Prior enrollment in this study\n10. Participation in any other investigational procedural, pharmaceutical, and\u002For device study that may influence the collection of valid data under this study","6 Years","80 Years",{"count":652,"type":22},29,[25],"This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during headache and non-headache periods.",[28],"2025-05-29",{"date":658,"type":33},"2025-05-30",{"date":660,"type":33},"2025-05-02",{"date":586,"type":22},{"name":68,"class":69},{"id":664,"slug":665,"hasResults":12,"nctId":666,"briefTitle":667,"officialTitle":667,"acronym":4,"eligibilityCriteria":668,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":669,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":671,"conditions":672,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":673,"lastUpdatePostDateStruct":674,"startDateStruct":676,"completionDateStruct":677,"leadSponsor":678,"locationsCount":41},"100547539","assessment-of-flow-in-cerebrospinal-fluid-shunts-with-a-second-generation-wireless-thermal-anisotropy-measurement-device-100547539","NCT06409286","Assessment of Flow in Cerebrospinal Fluid Shunts With a Second Generation Wireless Thermal Anisotropy Measurement Device","Inclusion Criteria:\n\n1. Existing ventriculoperitoneal CSF shunt on which the subject is dependent\n2. At least one symptom of shunt malfunction as determined by the investigator, such as but not limited to seizure, fever, headache, vision problems, dizziness, disorientation, confusion, vomiting, lethargy, irritability, difficulty waking or staying awake, swelling along shunt tract, enlargement of head, loss of balance, gait disturbance, and loss of sensory or motor function\n3. Exhibit shunt malfunction symptom(s) requiring surgical shunt revision per standard of care assessment without use of device data\n4. Region of intact skin overlying an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device\n5. Available for follow-up for up to seven days\n6. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as \"surrogates\" in this protocol)\n\nExclusion Criteria:\n\n1. Presence of more than one distal shunt catheter in the study device measurement region\n2. Presence of an interfering open wound or edema in the study device measurement area\n3. Subject-reported history of adverse skin reactions to adhesives\n4. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable\n5. Participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject\n6. Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired\n7. Participation in any other investigational procedural, pharmaceutical, and\u002For device study that may influence the collection of valid data under this study",{"count":670,"type":22},17,"This study evaluates the performance of a thermal anisotropy measurement device for non-invasively assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction who require shunt revision surgery will be evaluated with the study device to assess flow in CSF shunts as confirmed by surgical outcomes at 7 days. If successful, this study will show that the study device accurately distinguishes between functioning (flowing) and non-functioning (non-flowing) shunts.",[28],"2025-05-12",{"date":675,"type":33},"2025-05-15",{"date":584,"type":22},{"date":586,"type":22},{"name":68,"class":69}]