NCT07596030NARecruiting

Self-applied taVNS for CIPN

University of Miami

Start Date

6/2/2026

Completion Date

7/1/2027

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.

Eligibility Criteria

Age Range: 18 years to 80 years

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

Interventions

DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Chemotherapy Induced Peripheral Neuropathy

Locations

University of Miami, Plumer Building

Coral Gables, Florida 33146

United States