[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"peripheral-nerve-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:peripheral-nerve-disorder":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,86],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100575427","early-phase-1-early-feasibility-of-the-nervonik-peripheral-nerve-stimulation-device-100575427",false,"NCT06772142","Early Feasibility of the Nervonik Peripheral Nerve Stimulation Device","Inclusion Criteria:\n\n1. Subject is between 18 to 80 years of age at the time of enrollment.\n2. Subject has been diagnosed with knee, arm, or shoulder chronic pain (NRS of at least 5 out of 10).\n3. Post-surgical\u002Fpost-traumatic peripheral neuralgia including but not limited to pain due to peripheral nerve injury, post-surgical scar formation, nerve entrapment; Mononeuropathy, specified or unspecified or in diseases classified elsewhere; Other neuralgia or neuropathic pain\n4. Subject is willing to cooperate with the study requirements including, compliance with the study procedures and completion of all study visits.\n5. Subject reported stable pain (non-escalating) for 60 days prior to signing informed consent.\n6. Subject is currently receiving CMM and has had stable pain medication use and dosage for 30 days prior to signing informed consent.\n7. Subject is psychologically qualified to receive a peripheral nerve stimulator as per the clinician's standard clinical practice and judgment and does not have clinically relevant psychological condition(s) that would interfere with their ability to accurately report outcomes or complete study procedures.\n8. Subject has demonstrated the ability to appropriately place the wearable in the location where the IPG is most likely to be implanted. Alternatively, subject is able to appropriately use the relief belt and\u002For limb cuff to keep the wearable in place.\n\nExclusion Criteria:\n\n1. Subject currently has an active implantable medical device such as a drug pump, spinal cord stimulator, peripheral nerve stimulator, sacral nerve stimulator, deep brain stimulator, and\u002For cardiac pacemaker.\n2. Subject has previously failed PNS or Spinal Cord Stimulation (SCS) or Dorsal Root Ganglion (DRG) therapy (trial or permanent implant). See note below.\n3. Pain is completely absent at rest.\n4. Patient has clinical evidence of complex regional pain syndrome (CRPS), peripheral neuralgia of metabolic origin, post-herpetic neuralgia, biochemical evidence of a metabolic or genetic neuropathy (e.g., Charcot'- Marie- Tooth Disease) or mixed motor\u002Fsensory polyneuropathy.\n5. Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.\n6. Subject has had a successful (≥ 50% pain relief) interventional procedure within the past 3 months to treat the same pain condition(s) being examined in this study including, nerve blocks.\n7. Uncontrolled depression or uncontrolled psychiatric disorders\n8. Subject is currently participating in another clinical investigation with an active treatment arm.\n9. Subject is allergic or sensitive to materials used in the device components including, skin adhesives or does not tolerate the wearable aspect of the device.\n10. Subject has pending or ongoing legal issues (including unresolved worker's compensation claims or equivalent) or other conflicting secondary gain issues related to their chronic pain condition.\n11. Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, or progressive peripheral vascular disease that has not been medically corrected.\n12. Subject has an active systemic infection.\n13. Subject is unable to read and\u002For write in Spanish or give informed consent.\n14. Subject has a life expectancy of less than 1 year\n15. Subject has an active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome.\n16. Subject with uncontrolled diabetes mellitus, showing signs of diabetic neuropathy, as evidenced by a neurological exam and a HbA1c test.\n17. Subject has evidence of an alcohol or drug dependency within the last 6 months prior to enrollment.\n18. Subject is pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 1 year post-menopausal).\n19. Subject is nursing\u002Fbreastfeeding.\n20. Subject is on ≥90 mg-morphine equivalents per 24 hours. Recommend 60.\n21. Subject has undergone an ablative treatment of the target peripheral nerve, or proximal nerve trunk giving rise to the target nerve, or dorsal roots (and DRGs) that ultimately make up the target nerve. No ablative procedures directed at the spinal cord, dorsal roots, or peripheral nerve(s) being treated in the study. To note, subjects who have undergone RF ablation of the dorsal rami, cool pulsed RF of the facet innervation may be considered for enrollment","ALL","18 Years","80 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","A multicenter, 30 patient prospective single arm evaluation of the Nervonik system in symptomatic patients with chronic severe knee, elbow or shoulder pain.\n\nCOHORT 1: The initial cohort of patients will receive the Nervonik neurostimulator for up to 8 hours. The patient will remain local to the care facility for implant stimulator program changes until the patient is satisfied with the degree of pain relief. The implant will be removed from the patient at the end of the evaluation.\n\nCOHORT 2: The second cohort of patients will include those patients from cohort 1 who have determined the Nervonik implant provides suitable pain relief and agree to have a permanent implant placed. In addition, the second cohort includes non-cohort one patients meeting the trial requirements and agreeing to participate in the trial.",[26],"Peripheral Nerve Disorder",[28,29,30],"peripheral","nerve","stimulation","RECRUITING","2026-04-08",{"date":34,"type":35},"2026-04-13","ACTUAL",{"date":37,"type":35},"2024-11-27",{"date":39,"type":20},"2028-12-31",{"name":41,"class":42},"Nervonik","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":15,"minAge":16,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":64,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":43},"100625239","turkish-adaptation-of-the-cts-6-evaluation-tool-a-validation-and-reliability-study-100625239","NCT07420049","Turkish Adaptation of the CTS-6 Evaluation Tool: A Validation and Reliability Study","1\\) INCLUSION CRITERIA:\n\nParticipants aged 18-60 years will be categorized into three groups:\n\n1. Healthy Control Group\n2. Group Presenting with CTS-like Symptoms\n3. Group Diagnosed with CTS Based on Defined Criteria\n\na) Healthy Control Group: Participants in this group will have no clinical symptoms consistent with CTS based on specified clinical criteria and will be considered normal according to the defined electrophysiological criteria.\n\nb) Group Presenting with CTS-like Symptoms: Participants in this group may exhibit symptoms similar to clinically defined CTS; however, electrophysiological evaluations will show normal findings according to the defined criteria.\n\nb.1) Clinical Findings \u002F Symptoms:\n\nb.1.1) Symptoms:\n\n(A) Sensory symptoms in any of the 1st, 2nd, 3rd, or the radial part of the 4th finger\n\n(B) Symptoms alleviated by shaking, squeezing, or other hand movements\n\n(C) Pain or paresthesia associated with gripping or hand use\n\n(D) Nocturnal paresthesia causing awakening from sleep\n\nb.1.2) Diagnostic Tests \u002F Signs:\n\n1. Tinel Sign\n2. Phalen Test\n3. Reverse Phalen Test\n4. Carpal Tunnel Compression Test\n5. Flick Sign\n\n   A clinical diagnosis of CTS will require symptoms persisting for at least three months, with at least one of the B, C, or D symptoms in addition to symptom A, plus at least one positive diagnostic test or sign.\n\n   b.2) Electrophysiological Evaluation:\n\n   b.2.1) Mild CTS:\n\n   Median-to-ulnar sensory distal latency difference ≥ 0.4 ms at the 4th finger\n\n   Median nerve sensory distal latency ≥ 2.8 ms at the 2nd finger\n\n   Median nerve conduction velocity \\\u003C 50 m\u002Fs\n\n   Sensory nerve action potential ≥ 12 µV\n\n   b.2.2) Moderate CTS:\n\n   Median nerve distal motor latency at Abductor Pollicis Brevis (APB) 4 ms ≤ x \\\u003C 6.5 ms\n\n   Median nerve conduction velocity \\\u003C 50 m\u002Fs\n\n   Compound Muscle Action Potential (CMAP) ≥ 5 mV\n\n   b.2.3) Severe CTS:\n\n   Median nerve distal motor latency at APB ≥ 6.5 ms\n\n   Median nerve conduction velocity \\\u003C 50 m\u002Fs and\u002For CMAP \\\u003C 5 mV\n\n   c) Group Diagnosed with CTS Based on Defined Criteria: Participants in this group meet the clinical diagnostic criteria for CTS and additionally fulfill electrophysiological evaluation criteria for mild, moderate, or severe CTS.\n\n2\\) EXCLUSION CRITERIA:\n\n2.a) Participants Diagnosed with CTS Based on Defined Criteria:\n\nHistory of cardiac pacemaker\n\nHistory of lymphedema in the affected extremity\n\nHistory of cervical radiculopathy\n\nPresence of ipsilateral upper extremity tenosynovitis\n\nPresence of another compressive neuropathy in the ipsilateral upper extremity\n\nHistory of peripheral polyneuropathy\n\nPresence of metabolic disease\n\nHistory of fracture in the hand, wrist, or forearm\n\nCurrent pregnancy\n\nOpen wound on the wrist\n\nUncontrolled medical conditions (including endocrinological, cardiovascular, pulmonary, hematological, hepatic, renal, active systemic inflammatory disease, and\u002For malignancy)\n\nHistory of inflammatory rheumatologic or autoimmune disease\n\nAge \\\u003C18 years or \\>60 years\n\nTrauma to the wrist or median nerve within the last 3 months\n\nReceived any injection in the wrist\n\nUndergone any surgical procedure on the wrist\n\nMental or cognitive incapacity preventing understanding or completion of questionnaires\n\n2.b) Participants Presenting with CTS-like Symptoms:\n\nMental or cognitive incapacity preventing understanding or completion of questionnaires\n\nAge \\\u003C18 years or \\>60 years\n\nCTS diagnosis confirmed based on clinical and electrophysiological criteria\n\n2.c) Healthy Control Group Participants:\n\nMental or cognitive incapacity preventing understanding or completion of questionnaires\n\nAge \\\u003C18 years or \\>60 years\n\nPresence of any clinical symptoms potentially related to CTS based on defined clinical criteria\n\nElectrophysiological findings consistent with CTS",true,"60 Years",{"count":53,"type":20},126,"OBSERVATIONAL","The purpose of this study is to develop the Turkish version of the CTS-6 Evaluation Tool and to comprehensively assess its validity and reliability in the Turkish population. The CTS-6 Evaluation Tool is a widely used and reliable instrument for the assessment of diagnosis and symptom severity in patients with carpal tunnel syndrome.\n\nIn this study, the CTS-6 will undergo translation and cultural adaptation to ensure linguistic and cultural appropriateness for the Turkish population. The goal is to produce a valid, reliable, and practical tool that can be used efficiently in clinical settings. The adapted version is intended to be applicable across multiple medical specialties involved in the diagnosis and management of carpal tunnel syndrome in Turkey. The results are expected to provide a trustworthy Turkish version of the CTS-6 suitable for both clinical practice and research purposes.",[57,58,59,26,60,61,62,63],"Carpal Tunnel Syndrome (CTS)","Median Nerve Entrapment","Peripheral Nerve Disease","Reliability and Validity","Cross-cultural Adaptation","TURKISH VALIDITY AND RELIABILITY STUDY OF CTS-6 EVALUATİON TOOL","Diagnostic Tool",[65,66,67,68,69,70,63,71,72,73,74],"CTS-6 Evaluation Tool","CTS-6","Cross-cultural adaptation","Carpal Tunnel Syndrome","median nerve entrapment","reliability and validity","Peripheral nerve disease","Peripheral nerve disorders","Turkish version","Turkish Validity and Reliability Study of CTS-6 Evaluation Tool","NOT_YET_RECRUITING","2026-02-12",{"date":78,"type":35},"2026-02-19",{"date":80,"type":20},"2026-03-01",{"date":82,"type":20},"2026-07-01",{"name":84,"class":85},"Istanbul University","OTHER",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":50,"sex":15,"minAge":16,"maxAge":93,"enrollmentInfo":94,"targetDuration":96,"studyType":54,"phases":4,"briefSummary":97,"conditions":98,"keywords":103,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":43},"100563396","our-study-aims-to-determine-if-nerve-alterations-in-acute-gbs-and-cidp-detectable-by-ultrasound-match-electrodiagnostic-findings-and-if-this-method-aids-early-diagnosis-predict-their-outcomes-and-differentiate-between-axonal-and-demyelinating-subtypes-100563396","NCT06615622","Our Study Aims to Determine if Nerve Alterations in Acute GBS and CIDP Detectable by Ultrasound Match Electrodiagnostic Findings and if This Method Aids Early Diagnosis, Predict Their Outcomes and Differentiate Between Axonal and Demyelinating Subtypes.","A Comparative Study of Peripheral Nerve Ultrasound Findings in Immune Mediated Peripheral Nerve Disorders; a Hospital-based Study","Inclusion Criteria:\n\n1. Diagnosis of patient group:\n\n   * GBS Patients: Diagnosed according to the criteria of the National Institute of Neurological Disorders and Stroke (NINDS) and the Brighton Collaboration (2011).\n   * CIDP Patients: Diagnosed according to the criteria of the European Federation of Neurological Societies\u002FPeripheral Nerve Society (EFNS\u002FPNS).\n2. Age: Participants aged 18 to 75 years.\n3. Onset:\n\n   * GBS Patients: Recent onset of GBS within the first 2 weeks of symptom onset.\n   * CIDP Patients: Either relapsing or progressive course consistent with CIDP diagnosis.\n4. Gender: Both male and female participants are eligible.\n5. Participation: Willingness to participate in the study, including undergoing disease-related examinations and assessments.\n6. Consent: Ability and willingness to provide informed consent\n\nExclusion Criteria:\n\n1. Patients unable or unwilling to provide informed consent.\n2. Patients with metabolic disorders or malignancies.\n3. Patients with other causes of peripheral neuropathy.\n4. Patients with other causes of acute flaccid paralysis.","75 Years",{"count":95,"type":20},90,"6 Months","Neuromuscular ultrasound (NMUS) is emerging as a valuable non-invasive diagnostic tool. In GBS, NMUS can detect proximal nerve enlargement early, before neurophysiological changes. Persistent nerve enlargement can be observed up to 15 years, though its correlation with disability varies. Research is needed to clarify NMUS findings in GBS and CIDP over time. Early detection of nerve root enlargement via NMUS could facilitate earlier diagnosis and intervention, improving patient outcomes and understanding of these conditions\\' pathophysiology.\n\nThis study aims to determine if nerve alterations in acute GBS and CIDP detectable by ultrasound match electrodiagnostic findings and if this method aids early diagnosis. The investigators will perform serial nerve ultrasounds and NCS to investigate nerve morphology, predict outcomes, and differentiate between axonal and demyelinating subtypes.",[99,100,26,101,102],"Guillain Barré Syndrome","Chronic Inflammatory Demyelinating Polyradiculoneuropathy","Peripheral Nerves US","Peripheral Neuropathy",[104,105,106,107],"Peripheral nerve ultrasound","immune mediated nerve disorders","Guillain-Barré syndrome","Chronic inflammatory demyelinating polyradiculoneuropathy","2025-10-01",{"date":110,"type":35},"2025-10-03",{"date":112,"type":35},"2024-09-01",{"date":114,"type":20},"2028-03-30",{"name":116,"class":85},"Assiut University"]