Self-applied taVNS for CIPN

NCT07596030 | Recruiting DMC FDA Device

• 1 other identifier: 20260068
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Retention Rate (taVNS Intervention Cohort)

  Retention rate will be calculated as the percentage (%) of enrolled participants who complete all required study assessments by the end of their respective follow-up periods. Retention will be considered successful if ≥ 85% of enrolled participants complete the study.

  Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3)

• Retention Rate (Prospective Registry Cohort)

  Retention rate will be calculated as the percentage (%) of enrolled participants who complete all required study assessments by the end of their respective follow-up periods. Retention will be considered successful if ≥ 85% of enrolled participants complete the study.

  Baseline (Day 0 (T0) and Day 14 (T2)

• Recruitment Rate (taVNS Intervention Cohort)

  Recruitment rate will be calculated as the percentage of eligible participants who consent to participate in the study.

  Baseline (Day 0 (T0), through end of enrollment period (anticipated within 6 months)

• Acceptability (taVNS Intervention Cohort)

  Acceptability will be measured as the percentage of participants reporting overall acceptable or satisfactory experiences with the intervention during exit interviews. Acceptability will be considered successful if ≥ 80% of participants provide favorable responses.

  Baseline (Day 0 (T0) through Day 28 follow-up (T3) (approximately 6 weeks after baseline (T0)

• Treatment Adherence (taVNS Intervention Cohort)

  Treatment adherence will be assessed using the unique device-generated code associated with each taVNS session. Adherence will be considered successful if participants complete ≥ 80% of planned sessions as documented by device-logged session codes. Adherence will be calculated as: Number of completed session codes ÷ Number of programmed session codes) × 100 over the 14-day treatment period.

  14 days of intervention

Secondary Outcomes (8)

• Change in CIPN Symptoms Severity (EORTC QLQ-CIPN20) (taVNS Intervention Cohort)

  Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3)

• Change in Neuropathic Pain Intensity (Numeric Pain Rating Scale) (taVNS Intervention Cohort)

  Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3)

• Change in Serum Neurofilament Light Chain (NfL)

  Baseline (Day 0 (T0), to Day 14 (T2)

• Change in Serum Interleukin-1 Beta (IL-1β)

  Baseline (Day 0 (T0) to Day 14 (T2)

• Change in Serum Tumor Necrosis Factor-Alpha (TNF-α)

  Baseline (Day 0 (T0) to Day 14 (T2)

Study Arms (2)

taVNS Intervention Cohort

EXPERIMENTAL

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.

Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

No intervention (Prospective Registry Cohort)

NO INTERVENTION

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) 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.

taVNS Intervention Cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami, Plumer Building

Coral Gables, Florida, 33146, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Marlon L Marlon, PT, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard L Martinez, MSPH

CONTACT

3052842359; rxm1388@med.miami.edu

Marlon L Wong, PT, PhD

CONTACT

3052842670; mwong2@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical

Model Details: This study utilizes a parallel-cohort design comprising two distinct components: Interventional Feasibility Cohort 1: (n=24): Feasibility interventional cohort of self-applied taVNS in cancer survivors with chronic CIPN. Prospective Registry Cohort 2: (n=12): An observational, non-interventional comparator cohort of cancer survivors with similar taxane/platinum exposure who did not develop chronic CIPN.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)