Safety of Transcranial Direct Current Stimulation in the Subacute Phase After Stroke (NEUROSTIM)
Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke.
This study addresses this important issue, by evaluating, in the early phase post-stroke, effects of motor conventional physical therapy associated or not with transcranial direct current stimulation (tDCS).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The investigators main goal is to confirm the safety of transcranial direct current stimulation (tDCS) associated with conventional physical therapy, compared to conventional physical therapy associated with sham tDCS, for upper limb rehabilitation in an early phase (72 hours until 6 weeks) after stroke. Patients will be randomized to receive one of these two treatments, 3 times per week, for 2 weeks. Adverse effects will be monitored during each session. The working hypothesis is that conventional physical therapy associated with active tDCS in the subacute phase of ischemic stroke will be as safe as conventional therapy alone. The investigators will also preliminarily evaluate the efficacy of active tDCS associated with conventional therapy, compared to conventional therapy alone, in improvement of upper limb motor impairment. The investigators secondary goals are: 1) To compare effects of the above mentioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke ( subacute phase), immediately after treatment and 3 months later. The investigators hypothesis is that the association of conventional physical therapy and active tDCS will lead to better outcomes than conventional therapy alone. Patients will be assessed before the first session and after the last session of treatment, as well as 3 months after the last session of treatment.
Preliminary data about structural and functional connectivity will be collected in order to plan future studies related to mechanisms of tDCS in the subacute phase after stroke.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Sao Paulo, Brasil, 05652-901
- Danielle Boasquevisque
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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:
- Ischemic stroke confirmed by computed tomography or magnetic resonance imaging, with onset between 72 hours and 6 weeks before enrollment.
- Unilateral paresis of upper limb
- National Institute of Health Stroke Scale ( NIHSS) score of at least 1 point in items 5a or 5b .
- Ability to provide written informed consent (patient ou legal representative).
Exclusion Criteria:
- Lesions affecting the corticomotor pathway in the hemisphere contralateral to the stroke.
- Neurologic diseases except migraine.
- Modified Rankin Scale > 2 prior to stroke.
- Advanced systemic disease such as cancer or advanced chronic renal disease.
- Clinical instability such as uncontrolled cardiac arrhythmia or heart failure.
- Contraindication for physical therapy.
- Pregnancy.
- Absolute or relative contraindications to tDCS: metallic prosthesis in the head or neck; lesions on the scalp, history of neurosurgery, pacemaker.
- Comprehension aphasia
- Dementia
- Cerebellar stroke or ataxia caused by involvement of cerebellar pathways in the brainstem
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 tDCS+ Physical Therapy
Active tDCS (transcranial direct current stimulation) will be applied for 20 minutes.
After active session of tDCS, the patient will receive physical therapy for 60 minutes.
Number of treatment sessions: 6 (3 times a week, for 2 weeks)
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Active tDCS will be applied with the anode positioned over the ipsilesional primary motor cortex and the cathode over the contralateral supraorbital region for 20 minutes (1mA).
Physical therapy will be administered for 60 minutes
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Comparador falso: Sham tDCS+Physical Therapy
Sham tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After sham session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks) |
In sham tDCS, no current will be delivered through the tDCS device.
Physical therapy will be administered for 60 minutes
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Safety of the intervention as assessed by frequency of adverse events
Periodo de tiempo: 2 weeks
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frequency of adverse events in the active and sham arms
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2 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Improvement post treatment as measured by the Modified Rankin Scale
Periodo de tiempo: 2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Improvement post treatment as measured by the NIH Stroke Scale
Periodo de tiempo: 2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Improvement post treatment as measured by the Stroke Impact Scale
Periodo de tiempo: 2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Upper limb subscale of Fugl Meyer Assessment of Sensorimotor recovery after stroke
Periodo de tiempo: 2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Improvement post treatment as measured by the Modified Ashworth Scale
Periodo de tiempo: 2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Improvement post treatment as measured by the Motor Activity Log
Periodo de tiempo: 2 weeks and 14 weeks
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Improvement post treatment
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2 weeks and 14 weeks
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Montreal Cognitive Assessment Test
Periodo de tiempo: 2 weeks and 14 weeks
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No cognitive deterioration post treatment
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2 weeks and 14 weeks
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Structural Connectivity as measured by diffusion tensor imaging analysis
Periodo de tiempo: 2 weeks
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Improvement post treatment
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2 weeks
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Functional Connectivity as measured by resting-state functional magnetic imaging analysis
Periodo de tiempo: 2 weeks
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Improvement post treatment
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2 weeks
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Improvement post treatment as measured by the Barthel index
Periodo de tiempo: 2 week and 14 weeks
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Improvement post treatment
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2 week and 14 weeks
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Safety of the intervention as assessed by frequency of adverse events
Periodo de tiempo: 14 weeks
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frequency of adverse events in the active and sham arms
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14 weeks
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Improvement post treatment as measured by Pittsburgh Sleep Quality Index
Periodo de tiempo: 2 week and 14 weeks
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Improvement post treatment
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2 week and 14 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Adriana B Conforto, MD Phd, Hospital Israelita Albert Einstein
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 (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
- 225014
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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