- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03337867
Theta-Burst-Stimulation in Recurrent Stroke Recovery
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
To date, the majority of neuromodulation approaches aiming at improving motor recovery after stroke are limited to patients with first-ever ischemic stroke. Therefore, rehabilitation of recurrent stroke mainly includes physiotherapy and occupational therapy. Yet, particular these patients retain movement impairment relevant for activities of daily living.
By using repetitive transcranial magnetic stimulation (rTMS), it is possible to promote recovery of connectivity between brain regions, particularly after stroke and thereby improve motor performance. Previous data indicate that intermittent theta-burst stimulation (iTBS), a protocol of neuromodulation, enhances the effects of subsequent motor training in early rehabilitation after stroke.
The current study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery in recurrent stroke, compared to control condition, physiotherapy after sham stimulation. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Cologne, Alemania, 50937
- Christian Grefkles
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- written consent
- age: 40-90 years
- recurrent stroke
- hemiparesis with impaired hand motor function
Exclusion Criteria:
- Subjects who are legally detained in an official institute (§20 MPG)
- Electronic implants or ferromagnetic Implants located in the head, neck or thorax (e.g. clips, intracranial shunt, artificial heart valve, pacemaker)
- Medication pump (e.g. insulin pump)
- Metal splinters in eye or head
- Pregnancy / breastfeeding
- Severe Neurodegenerative disease
- Severe Neuroinflammatory disease
- History of seizures / epilepsy
- Physical addiction to alcohol, medication, or drugs (excluded: nicotine)
- Insufficient compliance
- Present or past malignant tumor involving the central nervous system
- Severe Psychiatric disease
- Frequent medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalization or long-term during hospitalization
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Real-iTBS
|
Intermittent theta-burst-stimulation (iTBS) protocol
Sham stimulation
|
Comparador falso: Sham-iTBS
|
Intermittent theta-burst-stimulation (iTBS) protocol
Sham stimulation
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Relative grip force
Periodo de tiempo: 3 months after enrollment
|
grip force as measured with vigorimeter
|
3 months after enrollment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Relative grip force
Periodo de tiempo: After 8 days of intervention, and 3 months of enrollment
|
Grip force as measured with vigorimeter
|
After 8 days of intervention, and 3 months of enrollment
|
Motor function
Periodo de tiempo: After 8 days of intervention, and 3 months of enrollment
|
Action Research Arm Test, ARAT
|
After 8 days of intervention, and 3 months of enrollment
|
Motor function
Periodo de tiempo: After 8 days of intervention, and 3 months of enrollment
|
Fugl-Meyer Motor Scale of the upper extremity, FM The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. Minimum score in upper limb = 0 Maximum score in upper limb = 66, Subscales are summed |
After 8 days of intervention, and 3 months of enrollment
|
Stroke severity
Periodo de tiempo: After 8 days of intervention, and 3 months of enrollment
|
National Instituts of Health Stroke Scale, NIHSS The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. |
After 8 days of intervention, and 3 months of enrollment
|
Degree of disability
Periodo de tiempo: After 8 days of intervention, and 3 months of enrollment
|
Modified Rankin Scale, mRS The scale runs from 0-6, running from perfect health (0) without symptoms to death (6).
|
After 8 days of intervention, and 3 months of enrollment
|
Motor cortex excitability/ Motor evoked potential
Periodo de tiempo: After 8 days of intervention, and 3 months of enrollment
|
Motor evoked potential (MEP) induced by stimulation of the affected motor cortex
|
After 8 days of intervention, and 3 months of enrollment
|
Motor cortex excitability/ Resting motor threshold
Periodo de tiempo: After 8 days of intervention, and 3 months of enrollment
|
Resting motor threshold as measured by stimulation of the affected motor cortex, RMT
|
After 8 days of intervention, and 3 months of enrollment
|
Motor cortex excitability/ Short-interval intracortical inhibition
Periodo de tiempo: After 8 days of intervention, and 3 months of enrollment
|
Short-interval intracortical inhibition Short-interval intracortical inhibition (SICI) is a widely used paired-pulse transcranial magnetic stimulation (TMS) measure to assess inhibition in human motor cortex
|
After 8 days of intervention, and 3 months of enrollment
|
Motor cortex excitability/ Ipsilateral silent period
Periodo de tiempo: After 8 days of intervention, and 3 months of enrollment
|
Ipsilateral silent period The ipsilateral silent period (iSP) is supposed to be a specific marker of transcallosal motor inhibition.
Measured by a short attenuation or interruption of ongoing voluntary electromyographic (EMG) activity in hand muscles induced by focal TMS of the ipsilateral M1.
|
After 8 days of intervention, and 3 months of enrollment
|
Quality of life
Periodo de tiempo: After 8 days of intervention, and 3 months of enrollment
|
EuroQol 5D questionnaire, EQ-5D
|
After 8 days of intervention, and 3 months of enrollment
|
Activities of daily living at admission and discharge in external rehabilitation facility
Periodo de tiempo: After 8 days of intervention, and 3 months of enrollment
|
Barthel-Index (BI) scores as documented by external rehabilitation facility The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL).
A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.
The scale yield a score of 0-100.
|
After 8 days of intervention, and 3 months of enrollment
|
Days of rehabilitation after intervention phase
Periodo de tiempo: 3 months after enrollment
|
Days of rehabilitation after intervention phase as documented by external rehabilitation facility
|
3 months after enrollment
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Christian Grefkes, MD, University Hospital Cologne
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- U1111-1204-6783
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
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. .
Ensayos clínicos sobre Magstim Super Rapid2 System
-
Bradley HospitalThrasher Research Fund; Rhode Island FoundationDesconocidoTDAH con déficit de memoria de trabajoEstados Unidos
-
UMC UtrechtTerminado
-
NYU Langone HealthTerminado
-
vghtpe userDesconocidoIncontinenciaTaiwán
-
Taipei Medical University WanFang HospitalTerminado
-
University of ManitobaReclutamientoAfasia progresiva logopénicaCanadá
-
New York State Psychiatric InstituteTerminadoTrastorno de despersonalizaciónEstados Unidos
-
Yale UniversityNational Institute of Mental Health (NIMH)TerminadoEsquizofreniaEstados Unidos
-
Ankara City Hospital BilkentTerminado
-
Ankara City Hospital BilkentTerminadoDepresión posterior al accidente cerebrovascularPavo