Noninvasive ear stimulation for HIV-related nerve pain
Official title: Mechanistic Modulation of HIV-Associated Peripheral Neuropathy in Older Adults Via Auricular Vagus Nerve Stimulation
Run by University of Miami · NCT07822932 · Data updated 2026-11-12
This study tests a non-invasive ear stimulation device to see if it can help nerve pain in people with HIV who have HIV-associated peripheral neuropathy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | University of Miami Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | November 2026 |
| Main results expected | August 30, 2028 |
| Study ends | September 30, 2028 |
| Registry record updated | October 6, 2026 |
| Trial ID | NCT07822932 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with established HIV infection and HIV-associated peripheral neuropathy with persistent symptoms for at least 3 months, and stable antiretroviral and pain therapy.
✕Probably not a fit
Patients with unstable cardiac conditions, implanted electronic devices, or other exclusions may not benefit and may be at risk.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study uses transcutaneous auricular vagus nerve stimulation to explore how the nervous system and heart respond in people with HIV-related neuropathy. Researchers aim to understand pain signaling and autonomic responses to guide future treatments for nerve pain in this population. The trial focuses on feasibility, safety, and preliminary signals of effectiveness in a controlled setting. Participants must have HIV infection with persistent neuropathic symptoms and stable care, without implanted devices or major cardiac risks. The study is conducted at a Miami site led by the University of Miami with support from NINDS.
Why it matters
Potential benefit: If successful, this approach could offer a non-drug option to reduce neuropathic pain in HIV and improve quality of life.
How similar studies have gone: Previous work in neuromodulation has shown promise in neuropathic pain, but this specific approach for HIV-associated neuropathy is exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Christine E Lynn Rehabilitation Center
Miami, Florida, United States Recruiting
Study contacts
- Principal investigator: Marlon L. Wong, PT, PhD — University of Miami
- Study coordinator: Marlon L Wong, PT, PhD
- Email: mwong2@miami.edu
- Phone: 3052842670
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.