Clinical trial for HIV Associated Polyneuropathy
Official title Auricular Vagus Nerve Stimulation Mechanisms for HIV-Associated Peripheral Neuropathy
ClinicalTrials.gov ID: NCT07822932
What this study is testing
- What it's testing
- The study wants to see how the body and nervous system react to ear stimulation, looking at heart function and pain signals.
- Who it's for
- It is for adults who have HIV and are experiencing nerve pain (peripheral neuropathy).
- What's involved
- Participants will receive non‑invasive ear stimulation and will have tests to measure heart function and pain signals during the study.
- Time commitment
- The study lasts a few weeks and involves several visits for stimulation and testing.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Active or uncontrolled comorbidities that independently cause neuropathy (e.g., recent chemotherapy, uncontrolled diabetes with documented...
See the full eligibility 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
- 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...
- Pregnancy or actively breast feeding
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.