[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600323":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":34,"locations":40,"responsibleParty":69,"collaborators":73,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":38,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":38,"enrollmentInfo":84,"targetDuration":38,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":42,"whyStopped":38,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"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",[41,58],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-71.05977,42.35843,{"lat":52,"lon":51},[55,57],{"name":29,"role":36,"phone":37,"phoneExt":38,"email":56},"kho5@bidmc.harvard.edu",{"name":29,"role":30,"phone":38,"phoneExt":38,"email":38},{"facility":33,"status":59,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},"NOT_YET_RECRUITING",{"type":49,"coordinates":61},[51,52],{"lat":52,"lon":51},[64,68],{"name":65,"role":36,"phone":66,"phoneExt":38,"email":67},"Tamar Berger, MD, PhD","617-632-6140","Tamar_berger@dfci.harvard.edu",{"name":65,"role":30,"phone":38,"phoneExt":38,"email":38},{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"SPONSOR_INVESTIGATOR","Ka-Wai Ho","Sponsor-Investigator",[74],{"name":33,"class":6},"100600323","nerve-excitability-in-cisplatin-induced-peripheral-neuropathy-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":85,"type":86},60,"ESTIMATED","INTERVENTIONAL",[89],"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.",[92,93,94,95],"Peripheral Neuropathy Due to Chemotherapy","Peripheral Neuropathy","Neurotoxicity Syndromes","Neuropathy",[92,93,94,95],"2026-04-18",{"date":99,"type":100},"2026-04-22","ACTUAL",{"date":102,"type":100},"2026-01-31",{"date":104,"type":86},"2028-12-31",{"name":71,"class":6},2]