Transcranial Stimulation and Motor Training in Stroke Rehabilitation (tDCS)
19 de junio de 2012 actualizado por: University of Oxford
Transcranial Direct Current Stimulation (tDCS) as a Potential Adjunct Intervention in Stroke Rehabilitation
This study aims to test whether repeated sessions of tDCS result in long-lasting improvements in motor function in patients with chronic stroke.
Descripción general del estudio
Estado
Desconocido
Intervención / Tratamiento
Descripción detallada
Previous research that utilises single sessions of tDCS have demonstrated functional improvements; however, these improvements are usually short-lived, lasting less than one hour before the patient's performance returns to baseline. It has been suggested that repeated stimulation sessions are required to elicit long-lasting improvements. We aim to consider these details over the duration of this research, during which patients with chronic stroke will attend for 16 sessions over the course of 3 months.
This research has important implications; previous studies suggest that such an approach has the potential to facilitate physical rehabilitation post-stroke and establish tDCS as a clinically viable rehabilitative tool. Recovery of motor skills may take many months to acquire and therefore strategies that have the potential to enhance acquisition of skill are of practical and scientific interest.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
80
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Oxford, Reino Unido
- Reclutamiento
- Centre for Functional MRI of the Brain (FMRIB)
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 - 80 years.
- Patients should be at least six months post first symptomatic stroke affecting motor function of the hand.
Exclusion Criteria:
- Anyone who does not have adequate understanding of verbal and written information in English, sufficient to complete any of the safety screening forms.
- Anyone who has a previous history of epilepsy, febrile convulsions as a child or recurrent fainting fits. Likewise, anyone who has a significant family history of epilepsy would be excluded as all these conditions carry a theoretical risk of increasing susceptibility to seizures.
- Any person who has a history of drug abuse or a previous history of a neurological or psychiatric illness, or has a history of neurosurgical procedure is excluded as they may be at increased risk of epilepsy and data collected may be influenced by their condition.
- Patients on some prescription medications such as anti-depressants may be excluded as they may be at an increased risk of seizures.
- Anyone who is currently taking or who has taken anti-malarial treatment in the last 72 hours.
- Pregnant women are excluded as a precaution as there is no data on the effect on maternal cranial stimulation on the fetus.
- Any metallic implant in the neck, head, or eye and anyone with any implanted electrical devices would be excluded as there is a risk of heating with both TMS and TDCS stimulation.
- Anyone with any metal implants or implantable device would be excluded as indicated by the MRI safety screening form. People who suffer with claustrophobia as they are unable to tolerate the scanner.
- Patients who have had more than one stroke. Patients who have had a stroke will also be excluded if they have limited communication in the form of aphasia or a history of dementia.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
|---|---|
|
Experimental: Anodal tDCS and Motor Training
Participants will receive anodal tDCS over the primary motor cortex of the ipsilesional hemisphere.
The following parameters will be used: stimulation intensity of 1mA for the first 20 minutes of motor training (9 consecutive sessions Monday-Friday).
|
Participants will receive anodal tDCS over the primary motor cortex of the ipsilesional hemisphere.
The following parameters will be used: stimulation intensity of 1mA for the first 20 minutes of motor training (9 consecutive sessions Monday-Friday).
All participants will receive a standardised motor training intervention for the upper paretic limb
|
|
Comparador falso: Sham tDCS and Motor Training
Participants will receive sham tDCS over the primary motor cortex of the ipsilesional hemisphere for the first 20 minutes of motor training (9 consecutive sessions Monday-Friday).
|
All participants will receive a standardised motor training intervention for the upper paretic limb
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fugl Meyer Assessment of Motor Recovery following Stroke
Periodo de tiempo: Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
|
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
|
Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
|
|
Wolf Motor Function Test
Periodo de tiempo: Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
|
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
|
Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
|
|
Action Research Arm Test
Periodo de tiempo: Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
|
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
|
Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
|
|
9 Hole Peg Test
Periodo de tiempo: Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
|
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
|
Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reaction Time Test
Periodo de tiempo: Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
|
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
|
Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
|
|
Stroke Impact Scale
Periodo de tiempo: Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
|
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
|
Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2011
Finalización primaria (Anticipado)
1 de diciembre de 2013
Finalización del estudio (Anticipado)
1 de diciembre de 2013
Fechas de registro del estudio
Enviado por primera vez
4 de agosto de 2011
Primero enviado que cumplió con los criterios de control de calidad
10 de agosto de 2011
Publicado por primera vez (Estimar)
11 de agosto de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
20 de junio de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
19 de junio de 2012
Última verificación
1 de junio de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 10/H0604/98
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .