Efficacy of Transcranial Direct Current Stimulation in Acute Ischemic Stroke (DAS)
Investigation of the Effects of Noninvasive Neuromodulation in Patients With Acute Ischemic Infarction
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Cerebral infarction is a major cause of death, a disease that is socially and nationally burdensome, leaving disabilities and dementia behind.
In participants with cerebral infarction, non-invasive brain stimulation (tDCS) such as transcranial direct current stimulation (TDCS) has been reported to be effective in improving motor performance and safe. However, few studies have been done in participants with acute cerebral infarction, and previous studies in participants with acute cerebral infarction have not verified the effect in mild cerebral infarction, and previous studies in acute cerebral infarction mainly stimulate lesions to anode. So in this study, the investigators want to see the effect of stimulating tDCS to both hemispheres in acute cerebral infarction against this backdrop.
Study Objective: To see if tDCS is effective in improving motor paralysis in participants with acute cerebral infarction.
Expected effectiveness: stability of tDCS has already been demonstrated in many studies. Since tDCS itself is a non-invasive treatment, if the efficacy of the tDCS prove to be effective in patients with acute cerebral infarction, it can be widely implemented without significant risk to many patients.
Intervention : In this randomized controlled trial, the investigators perform tDCS in patients with acute ischemic stroke within 48 hours after stroke onset with sham control.
Outcome : the investigators measure motor weakness and function at early phase as well as at 3 months.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Taewon Kim, MD, PhD
- Número de teléfono: +82-10-9399-5452
- Correo electrónico: kimtaewon79@gmail.com
Ubicaciones de estudio
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Incheon, Corea, república de, 21431
- Reclutamiento
- The Catholic University of Korea, Incheon St. Mary's Hospital
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Contacto:
- Taewon Kim, MD, PhD
- Número de teléfono: +82-10-9399-5452
- Correo electrónico: kimtaewon79@gmail.com
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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 patients within 2 days stroke onset
- 18-85 of age
- corticospinal tract involvement stroke (primary motor cortex, corona radiata, internal capsule, midbrain crus cerebri, basis pontis, anterior medulla)
Exclusion Criteria:
- pre-stroke disability (defined as modified Rankin Scale (mRS) >=2)
- Intravenous r-tPA thrombolysis or EVT (endovascular thrombectomy)
- history of epilepsy
- advanced systemic disease or coexisting neurological/psychiatric disease
- severe contact dermatitis or skin lesions interfering with the applying the electrode of tDCS
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: tDCS group
tDCS stimulation
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Transcranial direct current stimulation on motor cortex
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Comparador falso: Sham group
. Sham stimulation 1) the current ramps up to 2mA and slowly decreased over 30 s to ensure the typical initial tingling sensation |
Transcranial direct current stimulation on motor cortex
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fugl-Meyer (FM) motor scale, short form
Periodo de tiempo: at admission
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The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke.
FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).
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at admission
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Fugl-Meyer (FM) motor scale, short form
Periodo de tiempo: at 7 days
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The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke.
FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).
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at 7 days
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Fugl-Meyer (FM) motor scale, short form
Periodo de tiempo: at 3 month
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The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke.
FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit).
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at 3 month
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NIHSS (National Institutes of Health Stroke Scale)
Periodo de tiempo: at admission
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National Institutes of Health Stroke Scale (NIHSS) as a Neurologic.
Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).
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at admission
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NIHSS (National Institutes of Health Stroke Scale)
Periodo de tiempo: at 7 days
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National Institutes of Health Stroke Scale (NIHSS) as a Neurologic.
Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).
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at 7 days
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NIHSS (National Institutes of Health Stroke Scale)
Periodo de tiempo: at 3 month
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National Institutes of Health Stroke Scale (NIHSS) as a Neurologic.
Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit).
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at 3 month
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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modified Rankin scale
Periodo de tiempo: at 3 month
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The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
It has become the most widely used clinical outcome measure for stroke clinical trials.
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at 3 month
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Taewon Kim, MD, PhD, Incheon St.Mary's Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
- OC19DESI0124
Plan de datos de participantes individuales (IPD)
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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.
producto fabricado y exportado desde los EE. UU.
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