[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroinflammation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroinflammation":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,84,117,160],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100613658","phase-2-vitamin-d3-for-moderate-to-mild-traumatic-brain-injury-a-randomized-trial-on-inflammation-and-recovery-vimot-100613658",false,"NCT07269457","Vitamin D3 for Moderate to Mild Traumatic Brain Injury: A Randomized Trial on Inflammation and Recovery (VIMOT)","VIMOT","Inclusion Criteria:\n\n* Adults aged 18 to 65 years\n* Diagnosed with mild-to-moderate TBI defined by GCS 9-15\n* Presenting within 24 hours of head injury\n* Willing and able to provide informed consent or have a legal representative provide consent\n* Confirmed vitamin D-deficient status (\\\u003C30 ng\u002FmL) for randomization into treatment arms OR Vitamin D-sufficient (≥30 ng\u002FmL) to be eligible for inclusion in the observational control arm.\n\nExclusion Criteria:\n\n* Severe TBI (GCS ≤8)\n* Prior use of vitamin D supplements within the past month\n* History of hypercalcemia or hyperparathyroidism\n* Pregnancy or lactation\n* Use of immunosuppressive agents (e.g., corticosteroids, cytotoxic drugs)\n* Chronic liver disease\n* End-stage renal disease\n* Any terminal illness or comorbidity with expected survival \\\u003C3 months","ALL","18 Years","65 Years",{"count":20,"type":21},240,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is a Phase II, randomized, quadruple-blinded, placebo-controlled clinical trial designed to test whether vitamin D₃ supplementation can improve recovery after mild-to-moderate traumatic brain injury (TBI) in adults.\n\nTraumatic brain injury often leads to inflammation and poor neurological outcomes, and many patients are vitamin D-deficient. Vitamin D₃ is a safe, widely available supplement that may reduce inflammation and support brain recovery.\n\nA total of 240 adults (18-65 years) with mild-to-moderate TBI will be enrolled at Lagos State University Teaching Hospital, Nigeria. Participants will be assigned to one of four groups:\n\nGroup A (Deficient + High-Dose D₃): 40,000 IU loading dose, then 4,000 IU daily for 3 weeks Group B (Deficient + Standard-Dose D₃): 2,000 IU daily for 3 weeks Group C (Sufficient + Standard-Dose D₃): 2,000 IU daily for 3 weeks Group D (Sufficient + Placebo): placebo daily for 3 weeks All groups will be followed for 24 weeks. Blood tests at baseline, week 1, week 2, and week 4 will measure inflammation. Neurological recovery will be assessed at weeks 4, 12, and 24 using the Glasgow Outcome Scale-Extended (GOS-E) and Modified Rankin Scale (mRS).\n\nThe main outcomes are changes in inflammatory markers. Secondary outcomes include mortality, functional recovery, hospital stay, safety, and cost-effectiveness.\n\nThe results may identify a low-cost, scalable treatment to improve outcomes after TBI, especially in low-resource settings.",[27,28],"Traumatic Brain Injury (TBI) Patients","Neuroinflammation",[30,28,31,32,33,34],"Traumatic Brain Injury (TBI)","Vitamin D3","Glasgow Outcome Scale - Extended (GOS-E)","Modified Rankin Scale (mRS)","Sub-Saharan Africa","RECRUITING","2026-05-08",{"date":38,"type":39},"2026-05-13","ACTUAL",{"date":41,"type":39},"2026-03-02",{"date":43,"type":21},"2028-12-30",{"name":45,"class":46},"Lagos State University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":47},"100571299","tinnitus-and-treatment-with-umpea-lut-100571299","NCT06718452","Tinnitus and Treatment With umPEA-LUT","Treatment of Tinnitus Targeting Neuroinflammation. umPEALUT as Possible Option","TiniPEA","Inclusion Criteria:\n\n\\- Patients with tinnitus not under treatment at least for 30 days\n\nExclusion Criteria:\n\n* Stroke in the last year\n* Uncontrolled diabetes,\n* Uncontrolled hypertension,\n* Severe psychiatric disorders,\n* Severe cognitive decline,\n* Previous surgery of the brain or audio-vestibular nerves",true,"70 Years",{"count":59,"type":21},100,[61],"NA","Tinnitus can have different causes. From a peripheral point of view, the sensation of hearing a not present sound can be indicative of damage in the cells of the cochlea. Damage at this level can arise from traumatic, vascular, toxic origins or be caused by systemic pathologies. However, all the previous causes have a common denominator, the presence of reactive oxygen species (ROS), in the cochlea which determines the damage and the consequent death of the hair cells into the ear. The sound (tinnitus) that the patient perceives is generated by the spontaneous movement of the cilia of the hair cells; this phenomenon arises when these cells begin to be damaged.\n\nTinnitus can be also caused by a retrocochlear disorder such as damage of the auditory nerve (inflammatory and tumor cause). In case of an inflammatory origin, the factors released during inflammation can locally damage the nerves and spread into the cochlea destroying the hair cells.\n\nTinnitus can also originate from damage in the central auditory pathway. In this case, the problem persistent. It is important to keep in mind that although initially the tinnitus may originate from a damage inside the cochlea, after 6 months of persistence chronicizes causing an activation (without stimulus) of the upper auditory areas. This zone of \"hypersensitivity\" is therefore responsible for chronic tinnitus.\n\nIn addition to the overmentioned medical causes, tinnitus can also be sign of psychiatric\u002Fpsychological disorders, in those cases in whom there is an involvement of the hypothalamus, as showed by neuropsychological studies. Tinnitus can be temporary and disappear spontaneously or, in the most of cases, be persistent and extremely annoying\u002Fstressful for the patient. At night in particular, in the absence of noise, the patient suffers more the presence of this ghost sound, which in some occasions prevents sleep. Insomnia negatively impacts on tinnitus increasing its duration and intensity, thus establishing a perpetual cycle of stress into the brain. The latter phenomenon worses and chronicizes the symptom .\n\nStress causes inflammation with ROS increase, which can affect both the peripheral and central auditory pathways. Recently, it has been shown that tinnitus can be a symptom of neuro-inflammatory pathologies such as, for example, Multiple Sclerosis.\n\nThe effects of inflammation on the hair cells are identifiable only through electrophysiological studies or from the temporal bone.\n\nKeeping on mind inflammation and neuro-inflammation and considering the exchange between cerebrospinal fluid and perilymph , we speculate that the use of a molecule capable of reducing inflammation and modulating the action of mast cells and microglia, could be an effective tool to resolve tinnitus; moreover, thanks to its powerful action at the level of neuro-inflammation, it could reduce the hyper-activity in the upper auditory tracts, thus reducing\u002Fabolishing noise.\n\numPeaLut combines palmitoylethanolamide, which modulates the activity of mast cells, macrophages and microglia and luteolin, a bioflanoid extracted from fruits with anti-oxidant properties, able to improve microcirculation. Because the alterations of the ear microcirculation can be an additional cause of tinnitus, we believe that luteolin content can be an ulterior benefit.\n\nAlthough various attempts have been made to use a mono-molecule, recent studies have shown that combination of several elements could reduce tinnitus ; PeaLut, in its ultra-micronized form with high bioavailability, could be the perfect solution.\n\nThis study aims at evaluating the efficacy of umPEALUT as a therapeutic treatment of tinnitus in a sample of adults.",[64,28],"Tinnitus",[64,28,66,67,68,69,70,71,72,73],"Palmitoyetanolamide","Luteolin","Ultramicronized","Vascular","Central","Peripheral","Auditory cortex","Inner ear","NOT_YET_RECRUITING","2026-02-03",{"date":77,"type":39},"2026-02-06",{"date":79,"type":21},"2026-04-20",{"date":81,"type":21},"2026-12-31",{"name":83,"class":46},"University of Campania Luigi Vanvitelli",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":56,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":91,"targetDuration":4,"studyType":93,"phases":4,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":4},"100622787","neuroinflammatory-biomarkers-after-general-anesthesia-a-comparison-study-100622787","NCT07388160","Neuroinflammatory Biomarkers After General Anesthesia: A Comparison Study","Evaluation of Preoperative and Postoperative Serum BDNF, IL-1β, and HMGB1 Levels and Cognitive Changes in Patients Undergoing General Anesthesia: Differences Between Patients With No Prior General Anesthesia and Those With Multiple Anesthesia Exposures","Inclusion Criteria:\n\n* Age 18-65 years\n* Scheduled for elective cholecystectomy surgery\n* Either no previous general anesthesia exposure OR at least one or more previous general anesthesia exposures\n* Ability to provide informed consent\n* American Society of Anesthesiologists (ASA) physical status I-II\n\nExclusion Criteria:\n\n* Chronic neurological diseases (Alzheimer's disease, Parkinson's disease, multiple sclerosis, etc.)\n* Psychiatric illness requiring medication\n* Metabolic syndrome (diabetes mellitus, hypertension, cardiac disease)\n* Chronic inflammatory diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)\n* Corticosteroid or immunosuppressive therapy within the last 6 months\n* Patients requiring intensive care admission\n* Pregnancy or breastfeeding\n* Known allergy to anesthetic agents\n* Inability to provide informed consent",{"count":92,"type":21},160,"OBSERVATIONAL","This prospective, observational study investigates the impact of repeated general anesthesia exposure on neuroinflammatory biomarkers and neurotrophic factors. The study will enroll 160 adult patients (aged 18-65 years) scheduled for elective cholecystectomy surgery, divided into two groups: patients with no previous general anesthesia exposure (n=80) and patients with at least one or more previous general anesthesia exposures (n=80).\n\nSerum levels of Brain-Derived Neurotrophic Factor (BDNF), Interleukin-1 beta (IL-1β), and High Mobility Group Box 1 (HMGB1) will be measured using ELISA method at two time points: preoperatively (baseline) and 24 hours postoperatively. Cognitive function will also be assessed at both time points.\n\nThe primary objective is to evaluate whether multiple exposures to general anesthesia lead to significant differences in serum BDNF, IL-1β, and HMGB1 levels, reflecting changes in neurotrophic balance and neuroinflammatory response. This study aims to provide insights into the potential biochemical mechanisms underlying anesthesia-related cognitive changes and contribute original clinical data to the current literature on general anesthesia safety and neurobiological effects.",[96,28,97],"Anesthesia","Cognitive Disorders",[99,100,101,28,102,103,104,105,106],"Brain Derived Neurotrophic Factor","Interleukin-1 beta","General Anesthesia","Cognitive Dysfunction","Biomarkers","Sevofluran","Inflammatory Cytokines","Anesthesia Neurotoxicity","2026-01-30",{"date":109,"type":39},"2026-02-04",{"date":111,"type":21},"2026-01-25",{"date":113,"type":21},"2026-09-25",{"name":115,"class":116},"University of Health Sciences Balikesir Hospital Eduation and Research","OTHER_GOV",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":56,"sex":16,"minAge":17,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":93,"phases":4,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":47},"100590931","studying-the-neurobiological-mechanisms-of-non-specific-chronic-low-back-pain-and-chronic-insomnia-a-four-group-cross-sectional-study-100590931","NCT06973837","Studying the Neurobiological Mechanisms of Non-specific Chronic Low Back Pain and Chronic Insomnia: a Four-group Cross-sectional Study","Unravelling the Neurobiological Mechanisms Underlying the Bidirectional Relationship Between Chronic Sleep Disturbances and Pain Sensitivity in People With Non-specific Chronic Low Back Pain and Chronic Insomnia","SY-NAPS-CS","General inclusion criteria (all groups):\n\n* 18-60 years old.\n* Ability to speak and understand the Dutch Language.\n* Body mass index \\\u003C30.\n* No smoking or nicotine use.\n* Low caffeine use (≤3 cups of coffee\u002Fday, ≤1 energy drink\u002Fday).\n* Low alcohol use (≤9 alcoholic units\u002Fweek).\n* No use of neuro- and\u002For psychopharmacological treatments and\u002For immunosuppressive agents (including NSAIDs) with a suspected influence on neuroinflammation unless terminated within a sufficient time frame before the start of the study, or unless falling under the Pharmacological exceptions criteria (see below).\n* Willing to (try to) adhere to the acute pre-test restrictions, including refraining from analgesics (unless stable use), caffeine, alcohol, and\u002For strenuous physical activity (\\>3 METs) in the 24 hours preceding the main test day.\n\nGeneral exclusion criteria (all groups):\n\n* Shift worker.\n* Use of blood thinners.\n* (History of) Substance dependence\u002Fabuse.\n* Chronic pain conditions (≥3 months) other than chronic low back pain.\n* Severe intrinsic sleep disorders (assessed during a one-night, laboratory-based polysomnography).\n* Restless leg syndrome\n* Central or peripheral neurological disorder\u002Fcondition (e.g., epilepsy, multiple sclerosis, peripheral neuropathy).\n* History of spinal surgery.\n* Major medical (e.g., cardiac disease, cancer) and\u002For psychiatric disorder\u002Fdisease (e.g., major depressive disorder, bipolar disorder).\n* Claustrophobia.\n* Contraindications for magnetic resonance imaging (e.g., metal\u002Fcochlear implants, pacemaker).\n* Pregnancy or being \\\u003C12 months post-natal.\n\nPharmacological exceptions criteria:\n\n\\- Participants with chronic low back pain and\u002For (comorbid) insomnia will be allowed to be on a stable low dose of weak pain and\u002For sleep agents (e.g., Tramadol, Zolpidem) if medically prescribed specifically for their low back pain and\u002For insomnia, and if approved by the national medicine register of Belgium (FAMHP, Federal Agency for Medicine and Health Products). These participants will also be allowed stable and\u002For occasional use of low-to-moderate doses of over-the-counter medications for pain and\u002For sleep that are suspected to have no or minimal impact on neuroinflammation (e.g., paracetamol, melatonin). Habitual use of medications according to the above-stated criteria should be maintained across the entire study period, with the only exception being analgesics taken on an occasional basis. Specifically, because of the extensive battery of pain tests that will be utilized in the study, all analgesics that are only taken occasionally should be refrained from during the 24 hours preceding the main test day (pre-test instructions).\n\nSpecific inclusion criteria for \"pain-free\" groups:\n\n* Currently pain free, defined as having no pain that affects daily living\u002Ffunctioning and\u002For which has led to a consultation with a healthcare practitioner.\n* No episode of low back pain that interfered with daily functioning\u002Fliving and\u002For which led to a consultation with a healthcare practitioner within 12 months from the time of inclusion.\n* No history of chronic low back pain.\n\nSpecific inclusion criteria for \"chronic low back pain\" groups:\n\n* Low back pain reported on most days (≥50%), every week, for more than 3 months.\n* Low back pain-related emotional disress OR functional disability rated as ≥3 out of 10.\n\nSpecific inclusion criteria for \"good sleeper\" groups:\n\n* Stable sleep phase within 10 PM and 10 AM (assessed using the Pittsburgh Sleep Quality Index).\n* Average habitual total sleep time between 7 and 9 hours (assessed using the Pittsburgh Sleep Quality Index).\n* A Pittsburgh Sleep Quality Index ≤5.\n* An Insomnia Severity Index ≤7.\n* An Epworth Sleepiness Scale ≤10.\n* Sleep efficiency ≥85% during a one-night, laboratory-based polysomnography screening.\n* No episode of sleep disturbances that interfered with daily functioning\u002Fliving and\u002For which led to a consultation with a healthcare practitioner within the preceding 12 months from the time of inclusion.\n* No history of chronic insomnia.\n\nSpecific inclusion criteria for \"chronic insomnia\" groups:\n\n* Chronic insomnia according to the ICSD-3-TR criteria (assessed using an ICSD-3-TR-adapted version of the Pittsburgh Sleep Quality Index).\n* An Insomnia Severity Index ≥15.","60 Years",{"count":127,"type":21},80,"This study is a part of a larger project aiming to evaluate the neurobiological mechanisms underlying the relationship between sleep and pain in people with non-specific chronic low back pain. Specifically, this study aims to evaluate the neurobiological mechanisms underlying the relationship between chronic sleep disturbances and pain sensitivity in people with non-specific chronic low back pain and chronic insomnia.",[130,131,28],"Chronic Low Back Pain (CLBP)","Chronic Insomnia",[133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150],"Pain","Chronic pain","Chronic low back pain","Sleep","Insomnia","Chronic insomnia","Magnetic resonance imaging","Functional magnetic resonance imaging","Magnetic resonance spectroscopy","Diffusion weighted imaging","Quantitative sensory testing","Temporal summation","Conditioned pain modulation","Experience sampling method","Ecological momentary assessment","Microbiota","Gut-Brain axis","Short-chain fatty acids","2025-12-06",{"date":153,"type":39},"2025-12-15",{"date":155,"type":39},"2025-10-03",{"date":157,"type":21},"2026-10",{"name":159,"class":46},"Vrije Universiteit Brussel",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":56,"sex":16,"minAge":17,"maxAge":166,"enrollmentInfo":167,"targetDuration":169,"studyType":93,"phases":4,"briefSummary":170,"conditions":171,"keywords":174,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":187},"100571858","translocator-protein-petct-in-various-tspo-related-disease-100571858","NCT06725719","Translocator Protein PET\u002FCT in Various TSPO-Related Disease","Inclusion Criteria:\n\n\\- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled TSPO PET\u002FCT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.\n\nExclusion Criteria:\n\n\\- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.","80 Years",{"count":168,"type":21},200,"7 Days","To evaluate the potential usefulness of 18F-DPA714\u002FFDPA positron emission tomography\u002Fcomputed tomography (PET\u002FCT) for the diagnosis of primary and metastatic lesions in various TSPO-related disease patients.",[28,172,173],"Stroke","Neurodegenerative Diseases",[175,176,177],"PET\u002FCT","MRI","TSPO","2025-02-07",{"date":180,"type":39},"2025-02-11",{"date":182,"type":39},"2018-11-01",{"date":184,"type":21},"2027-12-01",{"name":186,"class":46},"Tianjin Medical University",2]