Auricular Vagus Nerve Stimulation Mechanisms for HIV-Associated Peripheral Neuropathy

Conditions

• HIV Associated Polyneuropathy

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Transcutaneous Auricular Vagus Nerve Stimulation (AVNS) — DEVICE
  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.

Study Details

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.

Key Dates

First listed

Sep 16, 2026

Start date

Nov 1, 2026

Status verified

Sep 2026

Primary completion

Aug 30, 2028

Completion

Sep 30, 2028

Study Design

Enrollment

70 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

Change in Short Interval intraCortical Inhibition (SICI) [ Time Frame: Baseline (Day 0), Post-trial (Day 14) ]

Central Contacts

• Marlon L Wong, PT, PhD
  3052842670
  [email protected]
• Richard Martinez, MS
  305-284-2359
  [email protected]

Locations (1)

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