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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Rachel E Cowan, PhD
- Número de telefone: 2059345034
- E-mail: recowan@uabmc.edu
Estude backup de contato
- Nome: Christopher Williamson, MBA
- Número de telefone: 2059343776
- E-mail: cmwilliamson@uabmc.edu
Locais de estudo
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- University of Alabama at Birmingham
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Contato:
- Rachel E Cowan, PhD
- Número de telefone: 2059345034
- E-mail: recowan@uabmc.edu
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Contato:
- Rachel
- Número de telefone: 2059345034
- E-mail: recowan@uabmc.edu
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Phase 1 Hypotension Symptoms Immediately before taVNS is applied
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Phase 1 Blood Pressure Immediately before taVNS is applied
Prazo: 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
Prazo: 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
Prazo: Immediately after taVNS Phase 1 application is stopped
|
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
Prazo: 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
Prazo: 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
Prazo: 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
|
Immediately after discharge from rehabilitation
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rachel E Cowan, PhD, University of Alabama at Birmingham
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB-300015896
- UAB (Outro identificador: UAB)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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