Recruiting

taVNS

Sponsor:

University of Miami

Code:

NCT07596030

Conditions

Chemotherapy Induced Peripheral Neuropathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Study Details

Brief 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.

Conditions

Chemotherapy Induced Peripheral Neuropathy

Study ID

NCT07596030

Start date

Jun 2, 2026

Status verified date

Jun, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not 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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

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.

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) ]
  • Retention Rate (Prospective Registry Cohort) [ Time Frame: Baseline (Day 0 (T0) and Day 14 (T2) ]
  • Recruitment Rate (taVNS Intervention Cohort) [ Time Frame: Baseline (Day 0 (T0), through end of enrollment period (anticipated within 6 months) ]
  • Acceptability (taVNS Intervention Cohort) [ Time Frame: Baseline (Day 0 (T0) through Day 28 follow-up (T3) (approximately 6 weeks after baseline (T0) ]
  • Treatment Adherence (taVNS Intervention Cohort) [ Time Frame: 14 days of intervention ]

Central Contacts and Locations

Central contacts

Richard L Martinez, MSPH

3052842359rxm1388@med.miami.edu

Marlon L Wong, PT, PhD

3052842670mwong2@miami.edu

Locations

University of Miami, Plumer Building

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Richard L. Martinez, MSPH

305-284-2359rxm1388@med.miami.edu

Marlon L Wong, PT, PhD

mwong2@miami.edu

Principal Investigator:

Marlon L. Wong, PT, PhD

More Information

Sponsor

University of Miami

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • vagus nerve stimulation
  • peripheral neuropathy
  • heart rate variability
  • transcranial magnetic stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-06-26.