RecruitingNot Applicable

Self-applied taVNS for CIPN

United States36 participantsStarted 2026-06-02

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Retention Rate (taVNS Intervention Cohort)

Timeframe: Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3)

Retention Rate (Prospective Registry Cohort)

Timeframe: Baseline (Day 0 (T0) and Day 14 (T2)

Recruitment Rate (taVNS Intervention Cohort)

Timeframe: Baseline (Day 0 (T0), through end of enrollment period (anticipated within 6 months)

Acceptability (taVNS Intervention Cohort)

Timeframe: Baseline (Day 0 (T0) through Day 28 follow-up (T3) (approximately 6 weeks after baseline (T0)

Treatment Adherence (taVNS Intervention Cohort)

Timeframe: 14 days of intervention

Trial details

NCT IDNCT07596030

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Richard L Martinez, MSPH

3052842359 rxm1388@med.miami.edu

View on ClinicalTrials.gov More Chemotherapy Induced Peripheral Neuropathy trials