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- Ensaio Clínico NCT02148887
Plasticity of Grey and White Matter in Response to Motor Skill Training in Healthy Individuals and Those With Spinal Cord Injury
Visão geral do estudo
Status
Descrição detalhada
Functional recovery following human spinal cord injury (SCI) remains frustratingly limited and the majority of patients are left with severe impairments. While rehabilitative training has been shown to improve clinical outcome following SCI and has a major effect on patients' quality of life, the neuronal mechanisms underpinning neurological and functional recovery are not well understood.
Until recently, degenerative changes in components of the CNS remote to a SCI were thought to occur slowly (over years) and correlate with the degree of disability. Using longitudinal MRI protocols we have shown that these structural changes in fact occur early and progress both at the cord and brain level according to a specific spatial and temporal pattern (Freund et al 2013). It is thought that these trauma-induced structural changes progress retrogradely along central motor nerve fibres of the myelinated corticospinal tract (CST) and this is accompanied over time by shrinkage of corticospinal projecting neuronal bodies. Crucially, patients with less atrophy throughout the CST were those with better clinical recovery at twelve months. Despite this significant recovery advantage in some patients, all participants showed irreversible tissue loss, potentially hindering further recovery. Using the neuroimaging biomarkers established in the previous study cited above, we now aim to assess whether specific and intensive motor learning through tasks for the upper and lower limb might slow or reverse the atrophy seen in the sensorimotor system.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Zurich, Suíça, 8008
- Universitätsklinik Balgrist
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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:
Patients:
- Injury to the spinal cord which leads to any neurological deficits
- able to provide Informed consent
Controls:
- able to provide informed consent
Exclusion Criteria:
- Pregnancy
- MRI incompatible
- Neurologic or physiatric disorders
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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SCI patients with upper limb impairment - Upper limb training
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SCI patients with lower limb impairment - Lower limb training
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Healthy controls - Upper limb training
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Healthy controls - Lower limb training
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Healthy controls - No intervention
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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MRI parameters: tensor based morphometry, longitudinal relaxation rate, magnetisation transfer and diffusion index changes in the cervical and cranial corticospinal tract, basal ganglia, motor, premotor and parietal cortex.
Prazo: MRI scans at weekly intervals (day 0, 7, 14, 28 and 84 after commencement of training)
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MRI scans at weekly intervals (day 0, 7, 14, 28 and 84 after commencement of training)
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Raw performance data in the upper and lower limb training task, recorded at each training session.
Prazo: Training sessions 4x1hour per week for 4 weeks
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Training sessions 4x1hour per week for 4 weeks
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Overall activity levels as recorded by a worn accelerometer and clinical scoring tests repeated immediately following the first and final training scan sessions (Day 0 and 28) and the 84 day follow-up scan.
Prazo: Training sessions 4x1hour per week for 4 weeks; clinical assessments at day 0, 28, 84
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Training sessions 4x1hour per week for 4 weeks; clinical assessments at day 0, 28, 84
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3D gait analysis will be performed on certain patients and control subjects at the first and final training scan sessions (Day 28) and the 84 day follow-up scan
Prazo: 3D gait analysis at day 0, 28, 84
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3D gait analysis at day 0, 28, 84
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Colaboradores e Investigadores
Patrocinador
Colaboradores
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 (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KEK-ZH-2013-0559/PB_2016-00624
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