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Self-applied taVNS for CIPN

Self-applied taVNS for CIPN

Recruiting
18-80 years
All
Phase N/A

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Overview

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

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

Study details
    Chemotherapy Induced Peripheral Neuropathy

NCT07596030

University of Miami

27 June 2026

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