Self-applied taVNS for CIPN
NCT07596030 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2026-06-26
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.
Conditions
- Chemotherapy Induced Peripheral Neuropathy
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.
Sponsors & Collaborators
-
University of Miami
lead OTHER
Principal Investigators
-
Marlon L Marlon, PT, PhD · University of Miami
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-02
- Primary Completion
- 2027-06-30
- Completion
- 2027-07-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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