๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Established HIV infection
* Glove/stocking dysesthesias lasting for โฅ3 months
* HIV-associated peripheral neuropathy (HIV-PN) related symptoms โฅ4 (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