Self-applied taVNS for CIPN
Recruiting now · Not applicable
Conditions studied: Chemotherapy Induced Peripheral Neuropathy
In brief
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.
Key facts
- Study ID
- NCT07596030
- Run by
- University of Miami
- People needed
- 36
- Starts
- 2026-06-02
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-06-26
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- University of Miami, Plumer Building — Coral Gables, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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