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Recruiting NCT07596030

Self-applied taVNS for CIPN

No phase Interventional Chemotherapy Induced Peripheral Neuropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS).
Who it may be relevant to
Registry conditions: Chemotherapy Induced Peripheral Neuropathy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Feasibility of Self-Applied Vagus Nerve Stimulation for Chemotherapy Induced Peripheral Neuropathy

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.

Interventions

  • Device 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 measures

  • 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]
Secondary outcome measures (8)
  • Change in CIPN Symptoms Severity (EORTC QLQ-CIPN20) (taVNS Intervention Cohort) [Time frame: 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) [Time frame: Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3)]
  • Change in Serum Neurofilament Light Chain (NfL) [Time frame: Baseline (Day 0 (T0), to Day 14 (T2)]
  • Change in Serum Interleukin-1 Beta (IL-1β) [Time frame: Baseline (Day 0 (T0) to Day 14 (T2)]
  • Change in Serum Tumor Necrosis Factor-Alpha (TNF-α) [Time frame: Baseline (Day 0 (T0) to Day 14 (T2)]
  • Change in Serum Interleukin-6 (IL-6) [Time frame: Baseline (Day 0, (T0) to Day 14 (T2)]
  • Change in SICI (neurophysiological measure of corticospinal excitability) [Time frame: Baseline (Day 0 (T0) to Day 14 (T2)]
  • Change in Heart rate variability (HRV, surrogate measure of autonomic balance) [Time frame: Baseline (Day 0 (T0) to Day 14 (T2)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami, Plumer Building — Coral Gables

Identifiers

NCT: NCT07596030 · 20260068

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗