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RECRUITING
NCT07596030
NA

Self-applied taVNS for CIPN

Sponsor: University of Miami

View on ClinicalTrials.gov

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.

Official title: Feasibility of Self-Applied Vagus Nerve Stimulation for Chemotherapy Induced Peripheral Neuropathy

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-06-02

Completion Date

2027-07

Last Updated

2026-06-26

Healthy Volunteers

No

Interventions

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.

Locations (1)

University of Miami, Plumer Building

Coral Gables, Florida, United States