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- Ensayo clínico NCT01333579
Low-frequency Transcranial Magnetic Stimulation To Enhance Motor Recovery In The Subacute Phase After Stroke
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Stroke is a major cause of disability and worldwide. Hand motor impairment is frequent after stroke. Even mild impairments of the upper limb negatively impact disability and quality of life in these patients significantly contributes to disability. Therapeutic alternatives for hand motor rehabilitation are deeply needed.
Repetitive transcranial magnetic stimulation (rTMS) has emerged as a potential tool to improve hand motor performance after stroke. While high-frequency rTMS (HF-rTMS) often increases motor cortical excitability, LF-rTMS often has the opposite effect. Up-regulation of excitability in the affected hemisphere by HF-rTMS or down-regulation of the UH by LF-rTMS can restore the balance in inter-hemispheric inhibition and hence, facilitate movement of the paretic hand Both strategies, as well as the combination of both, have yielded encouraging results when applied in proof-of-principle, single-session studies to patients with mild hand motor impairment in the subacute and chronic stages after stroke. However, few rTMS studies included patients less than six months after stroke, and effects of LF-rTMS of the unaffected hemisphere in patients with severe motor impairment in the subacute phase have not been yet reported.
The investigators opted for a novel approach to enhance hand motor recovery, by examining feasibility, safety and preliminary efficacy of either active or sham LF-rTMS of the UH or sham rTMS as add-on therapies to outpatient customary rehabilitation, to patients with mild to severe hand paresis, within 5-45 days after unilateral ischemic stroke. The investigators hypothesize that, at this stage, LF-rTMS will be feasible even in patients with severe motor deficits, will have minimal adverse events and will enhance effects of customary rehabilitation on hand motor performance.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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SP
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São Paulo, SP, Brasil, 05403000
- Laboratório de Neuroestimulação, HC/FMUSP
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- First-ever ischemic stroke in the internal carotid artery territory confirmed by CT or MRI, 5-45 days before, leading to contralateral hand weakness
- Age, 18-80 years
Exclusion Criteria:
- Cardiac pacemaker
- Pregnancy
- Implantable medication pump
- Intracranial hypertension
- History of seizures
- Metal in the head
- Decompressive surgery
- Other neurological diseases
- Shoulder pain
- Joint deformity in the paretic upper limb
- Severe chronic disease such as end-stage cancer or end-stage renal failure
- Inability to provide informed consent due to severe language or cognitive impairment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Active rTMS
1Hz active rTMS delivered to the unaffected hemisphere
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Repetitive transcranial magnetic stimulation, frequency of 1Hz, once a day for ten days.
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Comparador de placebos: Placebo rTMS
1Hz placebo rTMS delivered to the vertex
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Repetitive transcranial magnetic stimulation, frequency of 1Hz, once a day for ten days.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Motor function of the paretic hand evaluated with the Jebsen-Taylor test
Periodo de tiempo: Baseline, two weeks, 1 month, 3 and six months after end of treatment
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Baseline, two weeks, 1 month, 3 and six months after end of treatment
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Periodo de tiempo: Baseline, two weeks, 1 month, 3 and six months after end of treatment
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Baseline, two weeks, 1 month, 3 and six months after end of treatment
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Number of patients able to comply with the protocol
Periodo de tiempo: Baseline, two weeks, 1 month, 3 and six months after end of treatment
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Baseline, two weeks, 1 month, 3 and six months after end of treatment
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Force of the paretic hand
Periodo de tiempo: Baseline, two weeks, 1 month, 3 and six months after end of treatment
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Baseline, two weeks, 1 month, 3 and six months after end of treatment
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Fugl-Meyer evaluation of motor performance (upper limb)
Periodo de tiempo: Baseline, two weeks, 1 month, 3 and six months after end of treatment
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Baseline, two weeks, 1 month, 3 and six months after end of treatment
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Disability evaluated with the modified Rankin scale
Periodo de tiempo: Baseline, two weeks, 1 month, 3 and six months after end of treatment
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Baseline, two weeks, 1 month, 3 and six months after end of treatment
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Functional Independence Measure
Periodo de tiempo: Baseline, two weeks, 1 month, 3 and six months after end of treatment
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Baseline, two weeks, 1 month, 3 and six months after end of treatment
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Neurological impairment evaluated with the NIH Stroke Scale
Periodo de tiempo: Baseline, two weeks, 1 month, 3 and six months after end of treatment
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Baseline, two weeks, 1 month, 3 and six months after end of treatment
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Measures of corticomotor excitability evaluated with transcranial magnetic stimulation
Periodo de tiempo: Baseline, two weeks, 1 month, 3 and six months after end of treatment
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Baseline, two weeks, 1 month, 3 and six months after end of treatment
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Adriana Conforto, MD, PhD, HC/FMUSP/Fundação Faculdade de Medicina
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- NCT2006/55504-0
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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