Multichannel tDCS to Reduce Hypertonia in Patients With Prolonged DOC
Effects of Multichannel Transcranial Direct Current Stimulation to Reduce Hypertonia in Patients With Prolonged Disorders of Consciousness: a Pilot Study.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Following severe brain damage and coma, some patients may remain in a vegetative state (VS) or minimally conscious state (MCS). At present, there are no evidence-based guidelines regarding the treatment of patients with disorders of consciousness (DOC). A previous study showed that a single stimulation (using transcranial direct current stimulation - tDCS) of the left prefrontal cortex induces an behavioral improvement in some patients in DOC. Nevertheless, patients with DOC suffer from other invalidating dysfunctions such as spasticity (muscle hypertonia). In sroke patients, the inhibition of the motor cortex through cathodes placed over the motor region showed to reduce spasticity.
In this study, investigators aim to assess the effect of single session of transcranial direct current stimulation (tDCS) over right and left fronto-central areas (using 2 anodes and 2 cathodes), on the level of hypertonia and the level of consciousness of patients with DOC, in a double blind randomized sham controlled study. The anodes will be placed over F3 and F4, and the cathodes over C3 and C4.
tDCS is a form of safe non-invasive cortical stimulation, modulating cortical excitability under the electrodes, via weak polarizing currents. It has been reported that anodal tDCS transiently improves motor functions in healthy subjects and patients with stroke or Parkinson's disease.
By reducing the activity of the motor cortex (cathodes) and increasing the activity of the prefrontal cortex (anodes) we expect to observe a better motor function in patients with DOC.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Liege, Bélgica, 4000
- University of Liege
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
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Descripción
Inclusion Criteria:
- post comatose patients
- patients in minimally conscious state
- patients with stable condition
- patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)
Exclusion Criteria:
- premorbid neurology antecedent
- patients in coma
- patients < 28 days after the acute brain injury
- patients with a metallic cerebral implant
- cranioplasty
- shunt
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: active tDCS
Patients will receive tDCS (bilateral fronto-central stimulation) during 20 minutes preceded and followed by a clinical assessment (Modified Ashworth Scale and Coma Recovery Scale-Revised) and neurophysiological assessment (8 channels EEG).
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tDCS will be applied during 20 minutes with a current of 1 mA preceded and followed by a behavioral assessments (Modified Ashworth Scale and Coma Recovery Scale Revised) and an EEG.
The anodes will be placed over F3 and F4 and the cathodes over C3 and C4.
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Comparador falso: sham tDCS
Patients will receive sham tDCS (5 seconds of stimulation) during 20 minutes preceded and followed by a clinical assessment (Modified Ashworth Scale and Coma Recovery Scale-Revised) and neurophysiological assessment (8 channels EEG).
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Indentical to the active tDCS, except that the stimulation is terminated after 5 seconds.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in MAS scores
Periodo de tiempo: baseline and directly after tDCS (20 minutes)
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Modified Ashworth Scale (MAS) will by assessed before and after tDCS (active and sham).
Comparison of treatment effect (MAS score after tDCS minus before) between active and sham tDCS.
The MAS is a 5 points scale going from 0 (no spasticity) and 5 (extreme spasticity).
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baseline and directly after tDCS (20 minutes)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in the CRS-R total score
Periodo de tiempo: Baseline and directly after the tDCS (20 minutes)]
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Coma Recovery Scale Revised (CRS-R) will be performed before and after tDCS (anodal and sham).
Comparison of the treatment effect (CRS-R total score score after tDCS minus before) between real and sham tDCS.
The CRS-R is 23 points scale with 6 sub-scales (lower scores refer to reflexes, while higher scores refer to more complex behaviors).
The total score is the sum of the scores in the 6 sub-scales.
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Baseline and directly after the tDCS (20 minutes)]
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Change in brain oscillations
Periodo de tiempo: Baseline and directly after the tDCS (20 minutes)
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8 channels electroencephalography (EEG) will be record before and after tDCS to record potential cortical changes induce by the stimulation.
EEG power will be compared in different bandwidths (delta, theta, alpha, beta).
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Baseline and directly after the tDCS (20 minutes)
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Colaboradores e Investigadores
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Finalización del estudio (Actual)
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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
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Manifestaciones neurológicas
- Manifestaciones neuroconductuales
- Trastornos neurocognitivos
- Daño Cerebral Crónico
- Enfermedades musculoesqueléticas
- Enfermedades Musculares
- Manifestaciones Neuromusculares
- Inconsciencia
- Trastornos de la conciencia
- Hipertonía muscular
- Espasticidad muscular
- Estado vegetativo persistente
Otros números de identificación del estudio
- 2014/280B
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.
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