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Closed-Loop Vagus Nerve Stimulation (CLV) for Recovery of Gait After Spinal Cord Injury (SCI)

23 de julio de 2026 actualizado por: Dr. Seth Hays, The University of Texas at Dallas

Early Feasibility Study of the ReWire System for Closed-Loop Vagus Nerve Stimulation (CLV) Paired With Rehabilitation After Spinal Cord Injury (SCI) - Lower Limb Study

The purpose of this study is to evaluate the safety, feasibility, and preliminary effectiveness of the ReWire system, which delivers vagus nerve stimulation (VNS) paired with lower limb rehabilitation to improve gait in individuals with mobility impairments resulting from chronic, incomplete spinal cord injury (SCI).

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

A randomized, multi-center, double-blinded sham-control early feasibility trial of participants implanted with the ReWire System for spinal cord injury (SCI) with and open label extension.

During the pre-therapy phase, participants will undergo informed consent, baseline assessment, pre-operative evaluation, surgical implantation of the ReWire system, post-surgical assessment, and randomization. Following post-surgical assessment, participants will be block randomized in a 1:1 ratio to either active CLV (Immediate start group) or sham stimulation (Delayed start group) for the double-blind phase.

In double-blind phase, participants will complete up to 18 sessions of lower limb rehabilitation paired with CLV (Immediate start group) or sham stimulation (Delayed start group). Participants will then undergo assessment after completion of all sessions.

In open-label phase, all participants will receive up to an additional 18 sessions of CLV, regardless of their assignment in the double-blind phase. Participants will then undergo assessment after completion of all sessions.

A final, follow-up assessment will be conducted approximately 4 weeks (a month) from the previous assessment and cessation of CLV.

Long-term assessment of safety will be performed twice annually for up to 2 years from the date of implantation, following the completion of final assessment.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

20

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

Ubicaciones de estudio

  • Estados Unidos
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02129
        • Spaulding Rehabilitation Hospital, Mass General Brigham
        • Investigador principal:
          • Chad Swank, PhD
        • Contacto:
          • Jenny Zhang
          • Número de teléfono: 617-952-6354
          • Correo electrónico: jzhang71@mgb.org
    • Texas
      • Dallas, Texas, Estados Unidos, 75246
        • Baylor University Medical Center (BUMC)
        • Contacto:
        • Investigador principal:
          • Rita Hamilton, DO
      • Dallas, Texas, Estados Unidos, 75204
        • Urgent Surgery Associates, PA
        • Investigador principal:
          • Michael Foreman, MD
        • Contacto:
      • Richardson, Texas, Estados Unidos, 75080
        • Texas Biomedical Device Center
        • Contacto:
        • Investigador principal:
          • Robert Rennaker, PhD
        • Investigador principal:
          • Jane Wigginton, MD
        • 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

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Ability to provide signed and dated informed consent.
  2. Willingness and ability to comply with all study procedures and protocol requirements for the duration of the study.
  3. Age 18 to 64 years.
  4. Chronic, non-penetrating, motor incomplete spinal cord injury [Association Impairment Scale (AIS) grade C or D] occurring ≥12 months prior to enrollment, resulting in impairment in lower limb function.
  5. Ambulatory with residual gait impairment attributable to spinal cord injury.
  6. Self-selected gait speed of < 0.8 m/s as measured by the 10 meter walk test.
  7. Score of 2 or less on at least 4 measures on the Ambulation subsection of the SCI-Functional Independence scale (SCI-FIS).
  8. In otherwise good general health as determined by medical history and physical examination.
  9. Meets all clinical criteria for VNS implantation as determined by the Site PI and clinical care team.

Exclusion Criteria:

  1. Any history of spinal cord injuries by penetrating traumatic, non-traumatic or congenital causes.
  2. Evidence of right-sided recurrent laryngeal nerve injury on pre-operative laryngoscopy, if required (Note: Participants with a history of right-sided anterior cervical surgery must undergo laryngoscopy prior to surgical scheduling. A finding of right-sided recurrent laryngeal nerve injury results in exclusion).
  3. Excessive scar tissue on intraoperative assessment that precludes safe implantation (Note: Participants with a history of left-sided anterior cervical surgery will undergo intraoperative assessment of scar tissue. If excessive scar tissue is deemed to preclude safe implantation, the procedure will be abandoned and the participant excluded for safety reasons. A history of left-sided anterior cervical surgery or prior recurrent laryngeal nerve injury alone does not result in exclusion).
  4. Concomitant clinically significant brain injuries.
  5. Deficits in language or attention that interfere with study participation.
  6. Presence of any other implanted electrical stimulation device.
  7. Prior injury to the vagus nerve.
  8. Presence of any other implanted investigational device.
  9. Neck circumference of > 18.5 inches or significant overlying tissue and/or scarring that may hinder device communication.
  10. Psychiatric, psychosocial, and/or cognitive disorder or impairment that could interfere with study participation as assessed by medical evaluation.

  11. Current or past: (a) medical (psychiatric, non-psychiatric) condition, disease, disorder, injury, or disability*; or (b) non-medical situation or circumstance that, in the opinion of the Site PI, study participation:

    1. may pose a significant or undue risk to the person;
    2. make it unlikely the person will complete all the study requirements per protocol; or
    3. may adversely impact the integrity of the data or the validity of the study results.

    [*Examples include, but are not limited to, the following types of conditions, diseases or disorders: renal insufficiency or failure, vascular disease, unstable or concerning cardiac disease, endocrinologic concerns (e.g., poorly controlled diabetes), immunosuppression, respiratory issues, psychiatric (e.g., schizophrenia), neurologic (e.g., cognitive, seizure), sickle cell disease, lupus, clotting disorders, active neoplastic disease (excluding basal or squamous cell carcinoma of the skin with intent for curative excision), recent documented history (within the last 3 months) of dysphagia or aspiration difficulty]

  12. Is female and lactating, pregnant, or plans to become pregnant during the study. Participants of child-bearing potential that are sexually active must use a reliable form of birth control. Acceptable birth control methods: (a) sterilization surgery for women, (b) surgical sterilization implant for women, (c) sterilization surgery for men (including all male partners), (d) Long-acting reversible contraceptives (LARC)-implantable rod and Intrauterine Device (IUD), (e) contraceptive shots/injection every 3 months, (f) oral contraceptives (pills), (g) contraceptive patch, (h) vaginal contraceptive ring, and (i) complete abstinence.
  13. Abusive use of alcohol or drugs that could interfere with participation, as determined by the Site PI.
  14. Concurrently participating in another interventional clinical study.
  15. Requires or plans the use of diathermy, transcranial magnetic stimulation, or electroconvulsive therapy (ECT) during the course of the study.
  16. Is known to be under incarceration or legal detention as determined by the Site PI.
  17. Non-English speaking, unless the enrolling site has an IRB-approved translated consent and qualified medical interpreter resources available in the participant's language to support all study visits and procedures.

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 cruzada
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: CLV (Immediate start group)
The participants in this arm will be implanted with the device and will receive CLV in double-blind and open-label phases of the study.
Dispositivo: CLV
The participants in this group will be implanted with the ReWire system and receive CLV in the double-blind phase
Comparador de placebos: Sham (Delayed start group)
The participants in this arm will be implanted with the device and will receive sham in double-blind phase and CLV in open-label phase of the study.
Dispositivo: Sham
The participants in this group will be implanted with the ReWire system and receive Sham in the double-blind phase

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
ReWire System Safety
Periodo de tiempo: From device implantation to up to 2 years following implantation.
Safety of the ReWire system will be assessed by documenting the nature, frequency, severity, and relatedness of adverse events associated with the device, including those attributable to device implantation, stimulation delivery, and rehabilitation procedures.
From device implantation to up to 2 years following implantation.
ReWire System Feasibility
Periodo de tiempo: All visits after implantation, up to approximately 26 weeks post-enrollment.
Feasibility of the ReWire system will be assessed by the proportion of successful stimulation triggering events recorded in the ReWire System log during therapy sessions. The system will be considered feasible if >50% of valid trigger attempts result in successful stimulation delivery.
All visits after implantation, up to approximately 26 weeks post-enrollment.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
6 Meter Walk Test (6MWT)
Periodo de tiempo: At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
This measure assesses gait endurance by measuring the distance walked in 6 minutes along a hallway. Determine whether CLV improves six-minute walking test (6MWT) score compared to baseline. This measure is not a scale. Higher distance covered is better.
At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
10 Meter Walk Test (10MWT)
Periodo de tiempo: At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
This measure assesses walking speed (meter/second) over a short distance. Determine whether CLV improves 10-Meter Walk Test (10-MWT) score compared to baseline. This measure is not a scale. Lower time to complete is better.
At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
Timed Up-and Go (TUG)Test
Periodo de tiempo: At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
This measure assesses the functional mobility and fall risk by timing participants as they stand from a seated position, walk to a set point, and return to sit. Determine whether CLV improves Timed Up-and Go (TUG)Test score compared to baseline. This measure is not a scale. Lower time to complete is better.
At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
Walking Index for Spinal Cord Injury II (WISCI II)
Periodo de tiempo: At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
This measure assesses the type and amount of assistance required for walking. Determine whether CLV improves Walking Index for Spinal Cord Injury II (WISCI II) score compared to baseline. This scale is from 0-20. Higher scores indicate better walking performance.
At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
Lower Extremity Motor Score (LEMS)
Periodo de tiempo: At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
This measure quantifies the strength of five key muscle groups in each lower extremity. Determine whether CLV improves Lower Extremity Motor Score (LEMS) compared to baseline. This scale is from 0 to 50. Higher scores are better.
At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
SCI-Functional Independence Scale - Ambulation Subsection (SCI-FIS)
Periodo de tiempo: At baseline (screening), after implantation, week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).
This measure assesses self-perceived limitations with walking and basic mobility. This scale is from 0-24. Higher scores indicate better function.
At baseline (screening), after implantation, week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).
SCI Independence Measure (SCIM) III
Periodo de tiempo: At baseline (screening), after implantation, week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).
This measure assesses the functional independence (ability to safely perform daily activities without physical or cognitive assistance). This scale is from 0-100. Higher scores indicate greater independence.
At baseline (screening), after implantation, week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).
International SCI Pain Basic Data Set
Periodo de tiempo: At baseline (screening), after implantation, week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).
This measure is not a scale. It is a questionnaire consisting of items regarding overall pain and items regarding each of the three worst pain problems (assesses pain intensity and classification for each specific pain) in SCI patients.
At baseline (screening), after implantation, week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).
Observed Functional Change Assessment (OFCA)
Periodo de tiempo: At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
This measure is not a scale. It captures participants' reports/observations of positive functional changes (captures emergent functional gains-such as the appearance of new voluntary activation or task initiation-that may not yet be reflected in the numerical thresholds of standardized, performance-based scales).
At baseline (screening) and all visits after implantation, up to approximately 26 weeks post-enrollment.
Participant Satisfaction Survey
Periodo de tiempo: At week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).
This measure collects participant-reported feedback regarding usability, tolerability, and overall experience with CLV therapy.
At week 14 (double-blind phase), week 22 (Open-label phase) and week 26 (1 month follow-up).
Participant Blinding Questionnaire
Periodo de tiempo: At week 14 (double-blind phase).
This measure is not a scale. It assesses effectiveness of blinding from the participant perspective.
At week 14 (double-blind phase).
Therapist Blinding Questionnaire
Periodo de tiempo: At week 14 (double-blind phase).
This measure is not a scale. It assesses effectiveness of blinding from the treating therapist perspective.
At week 14 (double-blind phase).

Colaboradores e Investigadores

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

Patrocinador

The University of Texas at Dallas

Colaboradores

National Institute of Neurological Disorders and Stroke (NINDS)

Investigadores

  • Investigador principal: Jane Wigginton, MD, The University of Texas at Dallas
  • Investigador principal: Robert Rennaker, PhD, The University of Texas at Dallas
  • Investigador principal: Seth Hays, PhD, The University of Texas at Dallas
  • Investigador principal: Rita Hamilton, DO, Baylor University Medical Center (BUMC)
  • Investigador principal: Chad Swank, PhD, Spaulding Rehabilitation Hospital, Mass General Brigham
  • Investigador principal: Michael Foreman, MD, Urgent Surgery Associates, PA

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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)

30 de septiembre de 2026

Finalización primaria (Estimado)

1 de diciembre de 2028

Finalización del estudio (Estimado)

1 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

17 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de junio de 2026

Publicado por primera vez (Actual)

8 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de julio de 2026

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

23 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IRB-26-521
  • 5UG3NS131971-02 (Subvención/contrato del NIH de EE. UU.)
  • BSW 026-341 (Otro identificador: Baylor Scott & White Research Institute)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Demographic level data and outcomes.

Marco de tiempo para compartir IPD

Upon publication of main study findings.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • CIF

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.

Sí

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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