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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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.
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.
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.

Recruiting Locations

University of Miami, Plumer Building
Coral Gables, Florida 33146
Contact:
Richard L. Martinez, MSPH
305-284-2359
rxm1388@med.miami.edu

More Details

Status
Recruiting
Sponsor
University of Miami

Study Contact

Richard L Martinez, MSPH
3052842359
rxm1388@med.miami.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.