[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600323":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":34,"locations":40,"responsibleParty":68,"collaborators":72,"id":74,"slug":38,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":38,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":38,"enrollmentInfo":82,"targetDuration":38,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":42,"whyStopped":38,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Beth Israel Deaconess Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A: Participants Without Cisplatin-Induced Peripheral Neuropathy","EXPERIMENTAL","30 participants with no baseline neuropathy symptoms will be enrolled prior to starting cisplatin-based chemotherapy and will complete the following:\n\n* Baseline visit with neurological exams and conduction studies\n* Standard of care chemotherapy infusion (duration may vary depending on the chemotherapy regimen received)\n* Post-Infusion study visits via phone call (number of visits may vary depending on the chemotherapy regimen received)\n* In-clinic visit with neurological exams and conduction studies if participants develop cis-PN symptoms\n\n  --If participants do not develop cis-PN symptoms, participants will be reevaluated 1 month post end of cisplatin treatment\n* 7-day end of treatment visit via phone call\n* 1-month post-treatment visit with neurological exams and conduction studies",[13],"Diagnostic Test: Threshold Tracking Nerve Conduction Studies",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort B: Participants with Cisplatin-Induced Peripheral Neuropathy","30 participants with cis-PN symptoms will be enrolled and will complete the following:\n\n-One-time visit with neurological exams and conduction studies",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","Threshold Tracking Nerve Conduction Studies","Measurement of nerve excitability parameters, including response to sub-threshold pre-pulses and other stimuli. The DS5 0 Isolated Bipolar Constant Current Stimulator is a non-invasive, non-therapeutic device that provides controlled electrical stimuli for detailed function assessment of the superficial radial, superficial peroneal, ulnar, and sural nerves.",[9,15],[25,26],"TTNC","TTNCS",[28,31],{"name":29,"affiliation":5,"role":30},"Ka-Wai Ho, MD","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":33,"role":30},"Tamar Berger, MD PhD","Dana-Farber Cancer Institute",[35],{"name":29,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","617-667-1665",null,"Kho5@bidmc.harvard.edu",[41,57],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Boston","Massachusetts","02215","United States",{"type":48,"coordinates":49},"Point",[50,51],-71.05977,42.35843,{"lat":51,"lon":50},[54,56],{"name":29,"role":36,"phone":37,"phoneExt":38,"email":55},"kho5@bidmc.harvard.edu",{"name":29,"role":30,"phone":38,"phoneExt":38,"email":38},{"facility":33,"status":58,"city":43,"state":44,"zip":45,"country":46,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"NOT_YET_RECRUITING",{"type":48,"coordinates":60},[50,51],{"lat":51,"lon":50},[63,67],{"name":64,"role":36,"phone":65,"phoneExt":38,"email":66},"Tamar Berger, MD, PhD","617-632-6140","Tamar_berger@dfci.harvard.edu",{"name":64,"role":30,"phone":38,"phoneExt":38,"email":38},{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"SPONSOR_INVESTIGATOR","Ka-Wai Ho","Sponsor-Investigator",[73],{"name":33,"class":6},"100600323",false,"NCT07095998","Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy","Evaluation of Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy","Inclusion Criteria Cohort A:\n\n* Adults age ≥ 18 who will begin cisplatin-based chemotherapy either alone or in combination with other agents that are not known to cause neuropathy.\n* Participants must have adequate hematologic parameters to allow chemotherapy.\n\nExclusion Criteria Cohort A:\n\n* Pre-existing peripheral neuropathy;\n* Family history of a genetic\u002Ffamilial neuropathy;\n* Any contraindication for treatment with cisplatin as determined by their primary oncologist;\n* Chemotherapy regimen combining cisplatin with another known chemotherapy agent that may cause peripheral neuropathy;\n* Patients with cardiac or spinal stimulating devices;\n* Women who are pregnant or breastfeeding;\n* Adults with impaired consent capacity as patients must be able to fill out questionnaires regarding their neuropathy symptoms;\n* Other medical conditions that in the opinion of the treating physician would make the protocol unreasonably hazardous for the patient;\n* Patients not considered to be able to comply with the protocol.\n\nInclusion Criteria Cohort B:\n\n* Adults age ≥ 18 with a diagnosis of cis-PN.\n* The last dose of cisplatin must be ≥ 3 months prior to study enrollment. Patients who may have been previously enrolled in Cohort A of this study are eligible to participate in Cohort B if they continue to have cis-PN symptoms 3 months after completion of cisplatin therapy.\n\nExclusion Criteria Cohort B:\n\n* Pre-existing peripheral neuropathy;\n* Family history of a genetic\u002Ffamiliar neuropathy;\n* History of cisplatin-based regimen combining cisplatin with another known chemotherapy agent that may cause peripheral neuropathy;\n* Patients with cardiac or spinal stimulating devices;\n* Women who are pregnant or breastfeeding;\n* Adults with impaired consent capacity as patients must be able to fill out questionnaires regarding their neuropathy symptoms;\n* Other medical conditions that in the opinion of the treating physician would make the protocol unreasonably hazardous for the patient;\n* Patients not considered to be able to comply with the protocol.","ALL","18 Years",{"count":83,"type":84},60,"ESTIMATED","INTERVENTIONAL",[87],"NA","This study aims to evaluate nerve excitability in participants with cisplatin-induced peripheral neuropathy (cis-PN) using threshold tracking nerve conduction studies (TTNCS). By assessing changes in nerve excitability parameters, the study seeks to enhance understanding of the pathophysiology of cis-PN and identify early markers of neurotoxicity in participants undergoing cisplatin-based chemotherapy.",[90,91,92,93],"Peripheral Neuropathy Due to Chemotherapy","Peripheral Neuropathy","Neurotoxicity Syndromes","Neuropathy",[90,91,92,93],"2026-04-18",{"date":97,"type":98},"2026-04-22","ACTUAL",{"date":100,"type":98},"2026-01-31",{"date":102,"type":84},"2028-12-31",{"name":70,"class":6},2]