Pilot Testing of Vagus Nerve Stimulation for Early Spinal Cord Injury Recovery (PIVOTS-Rehab)
Pilot Investigation of Transauricular Vagal Nerve Stimulation Safety and Feasibility in Acute Incomplete Spinal Cord Injury Rehabilitation
This study looks at a treatment called transcutaneous auricular vagus nerve stimulation, or taVNS. taVNS uses a small device worn on the ear to gently stimulate a nerve. Researchers want to find out if this treatment is safe and well-tolerated for people who recently had a spinal cord injury (SCI).
This study will also help researchers learn whether taVNS can be safely added to standard mobility therapy, and whether it might help improve mobility.
This study has two main goals:
- To find out whether taVNS is safe and comfortable for people with a recent spinal cord injury.
- To get information on whether taVNS may help improve mobility when compared to people who completed rehabilitation before this study started.
This study has two parts.
In the first part, participants will wear the taVNS device once for a short period of time. During this part investigators will measure how participant's heart rate and blood pressure may change before, during, and after the stimulation. Investigators will also ask about how the stimulation made participants feel.
In the second part, participants will wear the taVNS device for a short time right before a mobility therapy session. During this part investigators will measure how participants heart rate and blood pressure may change before, during, and after the stimulation and during and after the walking therapy. Investigators will also ask about how the stimulation made participants feel.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Rachel E Cowan, PhD
- Número de teléfono: 2059345034
- Correo electrónico: recowan@uabmc.edu
Copia de seguridad de contactos de estudio
- Nombre: Christopher Williamson, MBA
- Número de teléfono: 2059343776
- Correo electrónico: cmwilliamson@uabmc.edu
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- University of Alabama at Birmingham
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Contacto:
- Rachel E Cowan, PhD
- Número de teléfono: 2059345034
- Correo electrónico: recowan@uabmc.edu
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Contacto:
- Rachel
- Número de teléfono: 2059345034
- Correo electrónico: recowan@uabmc.edu
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Phase 1 Age 18 years older SCI (traumatic or non traumatic) undergoing initial inpatient rehabilitation for the SCI Any AIS severity level (A, B, C, D)
- Phase 2 Completed phase I Participant willing to complete phase II Study physician approves participation in phase II Receives intensive gait training as a part of the care plan
Exclusion Criteria:
- Phase 1 Age >89 years Pregnant Implanted medical device (e.g. pacemaker, cochlear implant) epilepsy Parkinson's Disease Multiple Sclerosis cerebral shunts documented arrhythmia Ear skin irritation or damage at the electrode contact location intracranial metal implants
- Phase 2 no exclusion criteria for those who meet inclusion criteria
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 |
|---|---|
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Experimental: taVNS application
This is a single arm study with two Phases. In Phase 1 taVNS will be applied bilaterally for a brief period while the individual is in inpatient rehabilitation In Phase 2 taVNS will be applied for a brief period immediately before each mobility therapy session while the period is in inpatient rehabilitation. The mobility therapy sessions are routine care. Frequency and intensity of these sessions are determined by the therapists. All individuals must complete Phase 1 before starting Phase 2. Not all individuals who complete Phase 1 will be eligible for Phase 2. Please see eligibility criteria for more details. |
bilateral transauricular vagal nerve stimulation
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Phase 1 Hypotension Symptoms Immediately before taVNS is applied
Periodo de tiempo: Immediately before Phase 1 taVNS application
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Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
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Immediately before Phase 1 taVNS application
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Phase 1 Hypotension Symptoms during taVNS spplication
Periodo de tiempo: During application of Phase 1 taVNS
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Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
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During application of Phase 1 taVNS
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Phase 1 Hypotension Symptoms Immediately after taVNS is stopped
Periodo de tiempo: Immediately after Phase 1 taVNS is stopped
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Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
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Immediately after Phase 1 taVNS is stopped
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Phase 1 Hypotension Symptoms 5 minutes after taVNS is stopped
Periodo de tiempo: 5 minutes after Phase 1 taVNS is stopped
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Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
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5 minutes after Phase 1 taVNS is stopped
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Phase 1 taVNS Tolerability survey
Periodo de tiempo: Within 48 hours of competing Phase 1 taVNS
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10 question survey addressing perceived sensation, tolerability, side effects, and open text response
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Within 48 hours of competing Phase 1 taVNS
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Phase 2 taVNS Tolerability survey
Periodo de tiempo: Within 48 hours of completing Phase 2 taVNS
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10 question survey addressing perceived sensation, tolerability, side effects, and open text response
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Within 48 hours of completing Phase 2 taVNS
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Phase 1 Blood Pressure Immediately before taVNS is applied
Periodo de tiempo: Immediately before taVNS Phase 1 application is applied
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Systolic and Diastolic Blood Pressure (mmHg)
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Immediately before taVNS Phase 1 application is applied
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Phase 1 Blood Pressure during taVNS application
Periodo de tiempo: During taVNS Phase 1 application
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Systolic and Diastolic Blood Pressure (mmHg)
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During taVNS Phase 1 application
|
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Phase 1 Blood Pressure Immediately after taVNS is stopped
Periodo de tiempo: Immediately after taVNS Phase 1 application is stopped
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Systolic and Diastolic Blood Pressure (mmHg)
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Immediately after taVNS Phase 1 application is stopped
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Phase 1 Blood Pressure 5 minutes after taVNS is stopped
Periodo de tiempo: 5 minutes after taVNS Phase 1 application is stopped
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Systolic and Diastolic Blood Pressure (mmHg)
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5 minutes after taVNS Phase 1 application is stopped
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Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Admission
Periodo de tiempo: Admission to rehabilitation
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Total score on the IRF-PAI Section GG mobility.
Scores range from 15 to 90.
Extracted from the medical record
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Admission to rehabilitation
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Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Discharge
Periodo de tiempo: Immediately after discharge from rehabilitation
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Total score on the IRF-PAI Section GG mobility.
Scores range from 15 to 90.
Extracted from the medical record
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Immediately after discharge from rehabilitation
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rachel E Cowan, PhD, University of Alabama at Birmingham
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
- IRB-300015896
- UAB (Otro identificador: UAB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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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