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Auricular Vagus Nerve Stimulation Mechanisms for HIV-Associated Peripheral Neuropathy

10 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

70

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Marlon L Wong, PT, PhD
  • Número de teléfono: 3052842670
  • Correo electrónico: mwong2@miami.edu

Copia de seguridad de contactos de estudio

  • Nombre: Richard Martinez, MS
  • Número de teléfono: 305-284-2359
  • Correo electrónico: rxm1388@med.miami.edu

Ubicaciones de estudio

  • Estados Unidos
    • Florida
      • Miami, Florida, Estados Unidos, 33136
        • Christine E Lynn Rehabilitation Center
        • Contacto:
        • Investigador principal:
          • Marlon L. Wong, PT, PhD
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Dispositivo: 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.
Otros nombres:
  • Digitimer DS8R
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Short Interval intraCortical Inhibition (SICI)
Periodo de tiempo: 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)
Periodo de tiempo: (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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Neuropathic Pain Symptom Severity (NPSI)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Miami

Investigadores

  • Investigador principal: Marlon L. Wong, PT, PhD, University of Miami

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de noviembre de 2026

Finalización primaria (Estimado)

30 de agosto de 2028

Finalización del estudio (Estimado)

30 de septiembre de 2028

Fechas de registro del estudio

Enviado por primera vez

10 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

10 de septiembre de 2026

Publicado por primera vez (Actual)

16 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

10 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 20260653
  • 1R21NS149935-01 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Marco de tiempo para compartir IPD

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

Criterios de acceso compartido de IPD

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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • CÓDIGO_ANALÍTICO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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