Paired VNS For TBI Rehabilitation (VNS for TBI)
This study is evaluating whether pairing vagus nerve stimulation (VNS) with structured upper limb rehabilitation therapy can improve arm and hand function in individuals with moderate to severe traumatic brain injury (TBI).
Many people who survive a TBI experience long-term weakness, poor coordination, and difficulty using one arm or hand. These motor impairments can significantly affect independence and quality of life. Traditional rehabilitation can help, but recovery is often incomplete.
Vagus nerve stimulation (VNS) is an FDA-approved therapy for certain neurological conditions and involves a small device implanted under the skin in the chest with a lead connected to the vagus nerve in the neck. The device delivers mild electrical pulses to the nerve. In this study, VNS will be paired with goal-directed upper limb rehabilitation exercises. The stimulation is delivered during specific movements in therapy sessions. This "paired stimulation" approach is designed to enhance neuroplasticity - the brain's ability to reorganize and form new connections - which may improve motor recovery.
The VNS device used in this study is FDA-approved for other conditions. However, its use paired with rehabilitation for upper limb recovery after traumatic brain injury is investigational.
Participants in this study will:
Undergo surgical implantation of the VNS device.
Participate in structured upper limb rehabilitation therapy sessions where stimulation is paired with specific movements.
Complete follow-up visits and assessments to measure changes in arm and hand function, strength, dexterity, and overall recovery.
The main goal of the study is to determine whether paired VNS and rehabilitation improves upper limb motor function compared to rehabilitation alone. Safety will also be closely monitored, including surgical outcomes and any device-related effects.
This study may help determine whether VNS paired with rehabilitation is a safe and effective way to enhance motor recovery after traumatic brain injury. Findings from this research could contribute to improved treatment strategies for individuals living with long-term motor impairments following TBI.
Participation is voluntary. All participants will be carefully evaluated to determine eligibility, and informed consent will be obtained before enrollment.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sima Mofakham, PhD
- Número de teléfono: 631-444-1278
- Correo electrónico: sima.mofakham@stonybrookmedicine.edu
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 22-80 years
- History of severe TBI (initial GCS ≤ 8)
- Regained consciousness with capacity to consent to the study
- At least six months since injury
- Full recovery of consciousness with command following (mGCS = 6)
- Ongoing motor impairment with dependence in activities of daily living (modified Rankin Scale, mRS = 3-4)
- Clinically stable for VNS implantation
Exclusion Criteria:
- No capacity to consent to the study
- History of stroke
- History of cognitive disorder or other neurodegenerative disorder
- History of epilepsy treated by VNS
- History of brain tumors (primary or metastatic)
- Requires diathermy
- Pregnant
- Previously implanted vagus nerve stimulator
- Extensive prior neck surgery preventing dissection of the vagus nerve
- History of severe spasticity, vagus nerve damage, or hearing loss
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: VNS Group
Group to be implanted with VNS devices
|
Group will be implanted with VNS device for chronic TBI
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With Device- or Procedure-Related Adverse Events
Periodo de tiempo: 6 Weeks
|
Adverse events related to VNS device implantation or stimulation will be recorded and graded using CTCAE v5.0.
|
6 Weeks
|
|
Change in Upper Limb Range of Motion as Assessed by SeeMe Movement Analysis
Periodo de tiempo: 6 Weeks
|
Video-based kinematic analysis of upper limb range of motion, comparing baseline (pre-surgery) to post-training (6 weeks after VNS-paired rehabilitation).
|
6 Weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Disability Rating Scale (DRS) Score
Periodo de tiempo: 1 Year
|
RS score (range 0 [no disability] to 29 [extreme vegetative state]; lower scores indicate better outcome).
Magnitude of change will be used to estimate effect size for power calculation in a future multicenter randomized trial.
|
1 Year
|
|
Change in Coma Recovery Scale-Revised (CRS-R) Score
Periodo de tiempo: 6 Weeks
|
CRS-R total score (range 0-23; higher scores indicate better neurobehavioral function), comparing baseline to post-training.
|
6 Weeks
|
|
Change in Wolf Motor Function Test (WMFT) Performance Time
Periodo de tiempo: 6 Weeks
|
Time (seconds) to complete standardized WMFT tasks; lower time indicates better function.
Comparing baseline to post-training.
|
6 Weeks
|
|
Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE) Score
Periodo de tiempo: 6 Weeks
|
FMA-UE score (range 0-66; higher scores indicate better motor function), comparing baseline to post-training.
|
6 Weeks
|
|
Change in Motor Activity Log (MAL) Score
Periodo de tiempo: 1 Year
|
MAL Amount of Use and Quality of Movement subscales (range 0-5 each; higher scores indicate better real-world arm use).
|
1 Year
|
|
Change in EQ-5D-5L Index Score
Periodo de tiempo: 1 Year
|
EQ-5D-5L index score (range 0 [death] to 1 [full health]; higher scores indicate better quality of life).
|
1 Year
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Q251552
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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Ensayos clínicos sobre VNS for TBI group
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Boston Children's HospitalTerminadoEstrés Psicológico | Problema de aculturaciónEstados Unidos
-
Florida State UniversityUniversity of North Carolina, Chapel Hill; University of GeorgiaInscripción por invitaciónReducción del riesgo de enfermedades cardiovascularesEstados Unidos