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Auricular Vagus Nerve Stimulation Mechanisms for HIV-Associated Peripheral Neuropathy

10. september 2026 opdateret af: Marlon Wong, University of Miami

Mechanistic Modulation of HIV-Associated Peripheral Neuropathy in Older Adults Via Auricular Vagus Nerve Stimulation

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Marlon L Wong, PT, PhD
  • Telefonnummer: 3052842670
  • E-mail: mwong2@miami.edu

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • Christine E Lynn Rehabilitation Center
        • Kontakt:
        • Ledende efterforsker:
          • Marlon L. Wong, PT, PhD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Andre navne:
  • Digitimer DS8R
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Short Interval intraCortical Inhibition (SICI)
Tidsramme: Baseline (Day 0), Post-trial (Day 14)
Short-interval intracortical inhibition (SICI) will be assessed using paired-pulse transcranial magnetic stimulation (TMS) with a MagPro X100 stimulator. Change in SICI will be calculated as the difference between post-intervention and pre-intervention measurements. Negative values indicate increased intracortical inhibition.
Baseline (Day 0), Post-trial (Day 14)
Change in Root Mean Square of Successive Differences (RMSSD)
Tidsramme: (Days 1-13), Post-trial (Day 14)
The root mean square of successive differences (RMSSD), will be assessed using a three-lead electrocardiogram (ECG). Change in RMSSD will be calculated as the difference between post-intervention and baseline measurements. Higher RMSSD values indicate greater parasympathetic (vagal) activity and heart rate variability.
(Days 1-13), Post-trial (Day 14)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Neuropathic Pain Symptom Severity (NPSI)
Tidsramme: Baseline (Day 0), post-trial (Day 14)
Neuropathic pain symptom severity will be assessed using the Neuropathic Pain Symptom Inventory (NPSI), a patient-reported questionnaire that evaluates 10 neuropathic pain symptoms on an 11-point numeric scale ranging from 0 (no symptom) to 10 (worst symptom severity imaginable). The NPSI also includes 2 items assessing the duration of ongoing pain and the frequency of pain attacks. Higher scores indicate greater neuropathic pain symptom severity.
Baseline (Day 0), post-trial (Day 14)
Change in Neuropathic Symptom Intensity (Numeric Rating Scale)
Tidsramme: Baseline (Day 0), pre/post each treatment session (Days 1-13), post-trial (Day 14), and at follow up (Day 45)
Neuropathic symptom intensity will be assessed using the 0-10 Numeric Rating Scale (NRS). Participants will rate the average severity of HIV-associated peripheral neuropathy symptoms from 0 (not bothersome) to 10 (worst imaginable). Higher scores indicate greater symptom intensity.
Baseline (Day 0), pre/post each treatment session (Days 1-13), post-trial (Day 14), and at follow up (Day 45)
Change in Serum Neurofilament Light Chain (NfL)
Tidsramme: Baseline (Day 0), Post-trial (Day 14)
Serum neurofilament light chain (NfL) will be measured from non-fasted venous blood samples. NfL concentrations (pg/mL) will be quantified using enzyme-linked immunosorbent assay (ELISA). Change in NfL will be calculated as the difference between post-intervention and baseline serum concentrations. Higher concentrations indicate greater neuroaxonal injury.
Baseline (Day 0), Post-trial (Day 14)
Change in Serum Interleukin-1 Beta (IL-1β)
Tidsramme: Baseline (Day 0), Post-trial (Day 14)
Serum interleukin-1 beta (IL-1β) will be measured from non-fasted venous blood samples. IL-1β concentrations (pg/mL) will be quantified using enzyme-linked immunosorbent assay (ELISA). Change in IL-1β will be calculated as the difference between post-intervention and baseline serum concentrations. Higher concentrations indicate greater systemic inflammation.
Baseline (Day 0), Post-trial (Day 14)
Change in Serum Tumor Necrosis Factor-Alpha (TNF-α)
Tidsramme: Baseline (Day 0), Post-trial (Day 14)
Serum Tumor Necrosis Factor-Alpha (TNF-α) will be measured from non-fasted venous blood samples. TNF-α concentrations (pg/mL) will be quantified using enzyme-linked immunosorbent assay (ELISA). Change in TNF-α will be calculated as the difference between post-intervention and baseline serum concentrations. Higher concentrations indicate greater systemic inflammation.
Baseline (Day 0), Post-trial (Day 14)
Change in Wind-Up Ratio (WUR)
Tidsramme: Baseline (Day 0), Pre/post each treatment session (Days 1-13), Post-trial (Day 14)
Wind-up ratio (WUR), will be assessed using responses to repeated pinprick stimuli. Change in WUR will be calculated as the difference between post-intervention and baseline measurements. Lower WUR values indicate reduced temporal summation and decreased central sensitization.
Baseline (Day 0), Pre/post each treatment session (Days 1-13), Post-trial (Day 14)
Change in Conditioned Pain Modulation (CPM)
Tidsramme: Baseline (Day 0), Post-trial (Day 14)
Conditioned pain modulation (CPM), will be assessed using a cold pressor conditioning stimulus (1 to 4°C for 60 seconds) and pressure pain threshold (PPT) testing on the forearm. The CPM effect will be calculated as the percent change in PPT from before to after the conditioning stimulus (%ΔPPT). Higher CPM values indicate greater endogenous pain inhibition.
Baseline (Day 0), Post-trial (Day 14)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Miami

Efterforskere

  • Ledende efterforsker: Marlon L. Wong, PT, PhD, University of Miami

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

30. august 2028

Studieafslutning (Anslået)

30. september 2028

Datoer for studieregistrering

Først indsendt

10. september 2026

Først indsendt, der opfyldte QC-kriterier

10. september 2026

Først opslået (Faktiske)

16. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20260653
  • 1R21NS149935-01 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified participant-level clinical, physiological, biomarker, and patient-reported outcome data underlying published study findings.

IPD-delingstidsramme

By publication of primary study findings or no later than the end of the award period

IPD-delingsadgangskriterier

The study protocol, statistical analysis plan, informed consent form template, and analytic code will be made available upon publication of the primary results or study completion, consistent with the approved NIH Data Management and Sharing Plan. Materials will be shared through appropriate repositories and/or institutional platforms in accordance with participant privacy protections and applicable policies.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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