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Self-applied taVNS for CIPN

RecruitingNAAges 18 Years - 80 YearsAllUniversity of Miami
NCT07596030 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 re

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📋 Eligibility rules (as published)
Inclusion Criteria: Chemotherapy-induced peripheral neuropathy (CIPN) group: * Age 18-80 years * Prior exposure to platinum or taxane chemotherapy * Glove/stocking dysesthesias ≥3 months that began after neurotoxic chemotherapy * Worst CIPN-related pain ≥4/10 over the last week Registry Cohort: * Age 18-80 years * Prior exposure to platinum or taxane chemotherapy * Denis any current neuropathic symptoms as described above. Exclusion Criteria: All participants: * Unstable cardiac disease/ Known arrhythmias * Head or neck cancer or metastases * Recent ear trauma or active dermatologic disease at the stimulation site * \<2 months since completion of cancer treatment or surgery * Metal implants in the head or neck (e.g., cochlear implant) * Implanted electronic devices (e.g., pacemaker) * Known allergy to tape/adhesives * History of seizure/epilepsy, intracranial pathology, or skull defect * Pregnancy
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What it tests

  • Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
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Where

1 site
University of Miami, Plumer Building
Coral Gables, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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