Clinical Trial

Self-applied taVNS for CIPN

Recruiting
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Summary
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.
Protocol Amendment History 6 changes
critical Trial status changed: Withheld → Recruiting 2026-06-27
critical Phase changed: not specified -> not applicable 2026-06-27
critical Primary endpoint(s) modified 2026-06-27
notable Enrollment changed: None -> 36 2026-06-27
notable Sponsor changed: [Redacted] -> University of Miami 2026-06-27
minor Trial arms changed: 0 -> 2 2026-06-27
Trial Details
NCT Number NCT07596030
Lead Sponsor University of Miami
Conditions Chemotherapy Induced Peripheral Neuropathy
Enrollment 36 participants
Start Date 2026-06-02
Primary Completion 2027-06 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-26