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Self-applied taVNS for CIPN

RECRUITINGN/ASponsored by University of Miami
Actively Recruiting
PhaseN/A
SponsorUniversity of Miami
Started2026-06-02
Est. completion2027-06
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT07596030

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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

Conditions2

Chemotherapy-induced Peripheral NeuropathyHeart Disease

Locations1 site

University of Miami, Plumer Building
Coral Gables, Florida, 33146
Richard L. Martinez, MSPH305-284-2359rxm1388@med.miami.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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