[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638275":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":61,"collaborators":18,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":18,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":18,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Miami","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"taVNS Intervention Cohort","EXPERIMENTAL","Participants in this group will receive a 2-week course of daily self-applied transcutaneous auricular vagus nerve stimulation (taVNS) for chronic chemotherapy induced peripheral neuropathy (CIPN). Participants will use a portable taVNS device at home once daily for 14 consecutive days, applying stimulation to the auricular vagus nerve according to standardized instructions provided by the study team. Each stimulation session will last approximately 60 minutes at monophasic pulses. The treatment stimulation intensity can be increased up to 5mA, but this will be adjusted for each participant to ensure it is below the pain threshold.",[13],"Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)",{"label":15,"type":16,"description":17,"interventionNames":18},"No intervention (Prospective Registry Cohort)","NO_INTERVENTION","Participants in this group will not receive an intervention. This group consists of a prospective registry cohort of cancer survivors with prior taxane or platinum exposure who did not develop chronic chemotherapy induced peripheral neuropathy (CIPN). Participants will be enrolled into the registry for classification and observational comparison purposes only. No stimulation device is provided, and no active treatment or experimental procedure is administered during the 14-day registry period.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)","A portable taVNS Stimulator (Soterix Medical) will be used with flexible electrodes to administer taVNS near areas surrounding the ear. Each stimulation session will last approximately 60 minutes at monophasic pulses.",[9],[26],{"name":27,"affiliation":5,"role":28},"Marlon L Marlon, PT, PhD","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Richard L Martinez, MSPH","CONTACT","3052842359","rxm1388@med.miami.edu",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Marlon L Wong, PT, PhD","3052842670","mwong2@miami.edu",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University of Miami, Plumer Building","RECRUITING","Coral Gables","Florida","33146","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-80.26838,25.72149,{"lat":52,"lon":51},[55,58,59],{"name":56,"role":32,"phone":57,"phoneExt":18,"email":34},"Richard L. Martinez, MSPH","305-284-2359",{"name":36,"role":32,"phone":18,"phoneExt":18,"email":38},{"name":60,"role":28,"phone":18,"phoneExt":18,"email":18},"Marlon L. Wong, PT, PhD",{"type":28,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Marlon Wong","Associate Professor of Clinical","100638275","self-applied-tavns-for-cipn-100638275",false,"NCT07596030","Self-applied taVNS for CIPN","Feasibility of Self-Applied Vagus Nerve Stimulation for Chemotherapy Induced Peripheral Neuropathy","Inclusion Criteria:\n\nChemotherapy-induced peripheral neuropathy (CIPN) group:\n\n* Age 18-80 years\n* Prior exposure to platinum or taxane chemotherapy\n* Glove\u002Fstocking dysesthesias ≥3 months that began after neurotoxic chemotherapy\n* Worst CIPN-related pain ≥4\u002F10 over the last week\n\nRegistry Cohort:\n\n* Age 18-80 years\n* Prior exposure to platinum or taxane chemotherapy\n* Denis any current neuropathic symptoms as described above.\n\nExclusion Criteria:\n\nAll participants:\n\n* Unstable cardiac disease\u002F Known arrhythmias\n* Head or neck cancer or metastases\n* Recent ear trauma or active dermatologic disease at the stimulation site\n* \\\u003C2 months since completion of cancer treatment or surgery\n* Metal implants in the head or neck (e.g., cochlear implant)\n* Implanted electronic devices (e.g., pacemaker)\n* Known allergy to tape\u002Fadhesives\n* History of seizure\u002Fepilepsy, intracranial pathology, or skull defect\n* Pregnancy","ALL","18 Years","80 Years",{"count":75,"type":76},36,"ESTIMATED","INTERVENTIONAL",[79],"NA","The purpose of this study is to determine the feasibility of using a portable device at home to self-administer transcutaneous auricular vagus nerve stimulation (taVNS). This handheld device has two small electrodes that are placed on specific areas of the outer ear. This device delivers a mild electrical stimulation to the vagus nerve through the ear. This study will explore how taVNS may affect symptoms of chemotherapy-induced peripheral neuropathy (CIPN). Participants will be assigned to one of two cohorts based on the presence of chemotherapy-induced peripheral neuropathy (CIPN). Participants with CIPN will be placed in the intervention cohort (n=24) and will complete a 2-week trial of daily self-applied taVNS. Participants without CIPN will be placed in the registry cohort (n=12) and will complete study measurements without receiving the intervention. The registry cohort will not receive the taVNS intervention but will undergo identical physiological assessments at baseline and at a 2 week follow up to control for testing effects and biological variability.",[82],"Chemotherapy Induced Peripheral Neuropathy",[84,85,86,87],"vagus nerve stimulation","peripheral neuropathy","heart rate variability","transcranial magnetic stimulation","2026-06-25",{"date":90,"type":91},"2026-06-26","ACTUAL",{"date":93,"type":91},"2026-06-02",{"date":95,"type":76},"2027-07",{"name":5,"class":6},1]