Self-applied taVNS for CIPN

Conditions

• Chemotherapy Induced Peripheral Neuropathy

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) — DEVICE
  A portable taVNS Stimulator (Soterix Medical) will be used with flexible electrodes to administer taVNS near areas surrounding the ear. Each stimulation session will last approximately 60 minutes at monophasic pulses.

Study Details

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 Dates

Start date

Jun 2, 2026

Status verified

Jun 2026

Primary completion

Jun 30, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

36 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: taVNS Intervention Cohort
  Participants in this group will receive a 2-week course of daily self-applied transcutaneous auricular vagus nerve stimulation (taVNS) for chronic chemotherapy induced peripheral neuropathy (CIPN). Participants will use a portable taVNS device at home once daily for 14 consecutive days, applying stimulation to the auricular vagus nerve according to standardized instructions provided by the study team. Each stimulation session will last approximately 60 minutes at monophasic pulses. The treatment stimulation intensity can be increased up to 5mA, but this will be adjusted for each participant to ensure it is below the pain threshold.
• No Intervention: No intervention (Prospective Registry Cohort)
  Participants in this group will not receive an intervention. This group consists of a prospective registry cohort of cancer survivors with prior taxane or platinum exposure who did not develop chronic chemotherapy induced peripheral neuropathy (CIPN). Participants will be enrolled into the registry for classification and observational comparison purposes only. No stimulation device is provided, and no active treatment or experimental procedure is administered during the 14-day registry period.

Primary Outcome Measure

Retention Rate (taVNS Intervention Cohort) [ Time Frame: Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3) ]

Central Contacts

• Richard L Martinez, MSPH
  3052842359
  [email protected]
• Marlon L Wong, PT, PhD
  3052842670
  [email protected]

Locations (1)

Find similar trials in Coral Gables, FL

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