- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00970736
Stability of Motor Output in Aging Adults
Corticobulbar Motor Output in Aging Adults
Visão geral do estudo
Status
Condições
Descrição detalhada
A large number of our nation's veterans develop dysphagia due to the myriad of potential etiological sources of swallowing disorders, including stroke and head and neck cancer. The Veteran's Health Administration has recently identified dysphagia as a major clinical focus for the VA system (Sullivan & Dennis, 2006). In order to accurately assess adaptations in motor cortex, it is first necessary to have a reliable tool for measuring organizational representation in the motor cortex. Transcranial magnetic stimulation (TMS) is a desirable choice for such measurement because of the ability to identify causative relationships between an area of motor cortex stimulated and muscle response. Therefore, the specific research objectives of this proposal are:
- To demonstrate the reproducibility of TMS mapping of the submental muscle group in healthy older adults between 60 and 80 years of age
- To determine the neural representation of submental musculature in the motor cortex of healthy older adults between 60 and 80 years of age.
Twenty healthy adults, 10 men and 10 women, between the ages of 60 and 80 years will serve as research participants. TMS will be used to establish motor maps of the submental muscles. Subjects will undergo two testing sessions, on day 1 and day 14. The results from each session will be compared to assess excitability and representation within the motor cortex, and to assess stability and reliability of measurement.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Florida
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Gainesville, Florida, Estados Unidos, 32608
- North Florida/South Georgia Veterans Health System
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Between 60 and 80 years of age
Exclusion Criteria:
- History of dysphagia
- History of neurologic disease
- History of head or neck cancer
- History of stroke
- Untreated hypertension
- History of a heart condition or heart disease
- Currently pregnant
Contraindication to TMS including:
- Metallic hardware on the scalp in the area where TMS will be applied
- Cardiac pacemaker
- Implanted medication pumps or an intracardiac line
- Prior diagnosis of seizure or epilepsy in the subject (childhood history of benign febrile seizure will not be a contraindication)
- Poorly controlled migraine headaches
- Previous brain neurosurgery
- Medications that can lower seizure threshold (Appendix B)
- Unstable medical conditions
- Lowest motor thresholds above 80% on TMS
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
---|
1
20 healthy participants between 60 and 80 years of age.
Ten men and 10 women.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Mean Motor Evoked Potential Amplitude for Submental Cortical Representation
Prazo: 2 weeks
|
Cortical sites are stimulated sequentially from the SOLMT in the anterior direction.
At each site, 5 pulses of 110% of the MEP threshold obtained at the SOLMT are delivered and recorded.
If a site produces no MEP in 3/5 pulses it is considered non-submental.
This process is continued until the entire submental representation is surrounded by non-submental responsive sites.
The number of sites is used to calculate the area of submental representation.
The mean sEMG amplitudes of the submental muscles for each of these sites is then calculated for the mean MEP measure.
|
2 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Motor Map Center of Gravity
Prazo: 2 weeks
|
Position on the TMS motor map with highest amplitude response to stimulation in the muscles of interest (submental muscles).
|
2 weeks
|
Area of Submental Representation
Prazo: 2 weeks
|
Cortical sites are stimulated sequentially from the SOLMT in the anterior direction.
At each site, 5 pulses of 110% of the MEP threshold obtained at the SOLMT are delivered and recorded.
If a site produces no MEP in 3/5 pulses it is considered non-submental.
This process is continued until the entire submental representation is surrounded by non-submental responsive sites.
The number of sites is used to calculate the area of submental representation.
|
2 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Karen Hegland, PhD, North Florida/South Georgia Veterans Health System
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- C6697-M
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