Recruiting

Ear Stimulation

Sponsor:

University of Miami

Code:

NCT07822932

Conditions

HIV Associated Polyneuropathy

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation (AVNS)

Study Details

Brief summary:

This study looks at a non-invasive ear stimulation treatment to better understand nerve pain in people living with HIV. The study aims to assess how the body and nervous system respond to this treatment, including changes in heart function and pain signals. The goal is to learn how future treatments for nerve pain may be improved.

Conditions

HIV Associated Polyneuropathy

Study ID

NCT07822932

Start date

Nov, 2026

Status verified date

Oct, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Aug 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Established HIV infection
  • Glove/stocking dysesthesias lasting for ≥3 months
  • HIV-associated peripheral neuropathy (HIV-PN) related symptoms ≥4 (on a scale of 0-10) within the last week
  • Stable medical care (i.e., no changes in Antiretroviral Therapy or pain medication within 2 months of enrollment)
  • Able to read the consent form, demonstrate understanding of study procedures and requirements, and independently provide written informed consent

Exclusion Criteria:

  • Unstable cardiac disease
  • Implanted electronic or magnetic devices (e.g., pacemaker, cochlear implants, medication pumps, and other implanted neurostimulation systems)
  • Head or neck cancer or metastases
  • Recent ear trauma or metal implants in the head
  • History of epilepsy, unprovoked seizure, stroke, brain tumor, significant traumatic brain injury, prior intracranial surgery, or other neurological condition associated with increased seizure risk
  • Active or uncontrolled comorbidities that independently cause neuropathy (e.g., recent chemotherapy, uncontrolled diabetes with documented neuropathic complications)
  • Clinical evidence of non-HIV neuropathy (e.g., neuropathic symptoms predating HIV diagnosis, uncontrolled diabetes)
  • Known allergy to tape/adhesive
  • Ferromagnetic or non-MRI-compatible metal in the head, neck, eye, or cranial region, including aneurysm clips, retained metal fragments, bullets, shrapnel, or other metallic implants not demonstrated to be TMS-compatible.
  • Pregnancy or actively breast feeding

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Auricular Vagus Nerve (AVNS) Group

Participants in this group will receive 6 sessions of transcutaneous auricular vagus nerve stimulation (AVNS) over 2 weeks. Each stimulation session will last approximately 90 minutes at monophasic pulses.

no intervention: Waitlist Control

Participants in this group will not receive an intervention. Participants will be placed on a waitlist to try the intervention and will be assessed pre and post the 2-week waiting period. No stimulation device is provided, and no active treatment or experimental procedure is administered during the 14-day waitlist period.

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation (AVNS)

Transcutaneous auricular vagus nerve stimulation (taVNS) will be administered at the cymba concha using hydrogel electrodes and a Digitimer DS8R biphasic constant-current stimulator. Participants will receive 90-minute stimulation sessions consisting of monophasic pulses (pulse width: 500 microseconds; frequency: 25 Hz; duty cycle: 50%). Stimulation intensity will be set at 200% of the participant's sensory perception threshold and may be adjusted up to 5 milliamperes (mA) while remaining below the pain threshold.

Primary outcome measure

  • Change in Short Interval intraCortical Inhibition (SICI) [ Time Frame: Baseline (Day 0), Post-trial (Day 14) ]
  • Change in Root Mean Square of Successive Differences (RMSSD) [ Time Frame: Baseline (Day 0), pre/post each intervention session (Days 1-13), and post-trial (Day 14) ]

Central Contacts and Locations

Central contacts

Marlon L Wong, PT, PhD

3052842670mwong2@miami.edu

Richard Martinez, MS

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

Locations

Christine E Lynn Rehabilitation Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Richard A Martinez, MS

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

Oct 6, 2026

Last verified

Oct, 2026

Keywords

  • HIV-Associated Peripheral Neuropathy
  • Neuropathic pain
  • Auricular Vagus Nerve Stimulation
  • Vagus Nerve Stimulation
  • Neuromodulation
  • Aging
  • Heart Rate Variability
  • Quantitative Sensory Testing
  • Neuroinflammation
  • Corticospinal Excitability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by University of Miami on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.