Self-applied ear vagus nerve stimulation for chemotherapy-induced neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests the feasibility of a portable, at-home taVNS device that delivers mild electrical stimulation to the vagus nerve via the ear. Participants with CIPN will use the device daily for two weeks, while a separate registry group will undergo the same assessments without receiving the stimulation. The trial includes adults 18-80 who previously received platinum or taxane chemotherapy and have persistent CIPN or no current neuropathy, with safety and physiological measures collected at baseline and during the study. Outcomes focus on feasibility, tolerability, and physiological responses, alongside symptom reporting. The study is conducted at the University of Miami and aims to inform future larger trials.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Miami, Plumer Building
  Coral Gables, Florida, United States Recruiting

Study contacts

• Principal investigator: Marlon L Marlon, PT, PhD — University of Miami
• Study coordinator: Richard L Martinez, MSPH
• Email: rxm1388@med.miami.edu
• Phone: 3052842359

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Blood extracellular vesicles to detect chemotherapy-related nerve damage.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.