- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02284087
Paired Associative Stimulation in Post-stroke Hand Motor Deficits (PAS-stroke)
Assessment of Paired Associative Stimulation Protocols Using Cerebellar or Visual Afferences in Post-stroke Hand Motor Deficits
Introduction The motor impairment of the upper extremity is the most common sequelae after ischemic stroke. Transcranial magnetic stimulation (TMS) is a promising non- invasive technique in the rehabilitation of motor deficits. However, its effect in post-stroke motor deficits remains moderate our days. To potentiate the effect of TMS, techniques called Paired Associative Stimulations (PAS) involving the integration of afferent sensory inputs at the level of the ipsilesional primary motor cortex were developed in healthy subjects. PAS techniques have shown a gain of corticospinal excitability by such phenomenon known as long Term Potentiation (LTP) and a gain of motor performance. The investigators would like to propose to evaluate two types of these techniques with a volley of visual afferents (visuomotor stimulation, V_PAS) or of cerebellar afferents (CER_PAS), because these two structures convey important information in the execution of the movement.
Design Multicenter, randomized, study, 60 patients in 3 parallel groups (V_PAS, CER_PAS, control group with sham and sham V_PAS CER_PAS), 5 days of treatment, clinical assessment, electrophysiological and MRI before, immediately post- and second post-assessments (4 weeks).
A group of 24 healthy subjects will undergo a parallel physiopathological study on the underlying mechanisms of cerebellar PAS
Objectives Main objective: To determine whether (and how) Paired Associative Stimulation technique (PAS) induces cerebral reorganization in the primary motor cortex compared to the control group.
Aim 2: Determine whether (and which) type of PAS is capable of inducing changes in motor performance of the upper limb paresis and duration Aim 3: Determine whether (and which) type of PAS is capable of inducing changes in excitability of the corticospinal tract and duration Aim 4: Determine how PAS techniques modify the functional connectivity during movement Aim 5: Determine if connectivity changes during induced movement correlate with clinical improvements Aim 6: Determine whether patients who benefit of a type of PAS have specific anatomical lesion characteristics (volume, afferent and efferent white matter fasciculi integrity)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Introduction The motor impairment of the upper extremity is the most common sequelae after ischemic stroke. Transcranial magnetic stimulation (TMS) is a promising non- invasive technique in the rehabilitation of motor deficits. However, its effect in post-stroke motor deficits remains moderate the investigators days. To potentiate the effect of TMS, techniques called Paired Associative Stimulations (PAS) involving the integration of afferent sensory inputs at the level of the ipsilesional primary motor cortex were developed in healthy subjects. PAS techniques have shown a gain of corticospinal excitability by such phenomenon known as long Term Potentiation (LTP) and a gain of motor performance. The investigators would like to propose to evaluate two types of these techniques with a volley of visual afferents (visuomotor stimulation, V_PAS) or of cerebellar afferents (CER_PAS), because these two structures convey important information in the execution of the movement.
Design Multicenter, randomized study, 60 patients in 3 parallel groups (V_PAS, CER_PAS, control group with sham and sham V_PAS CER_PAS), 5 days of treatment, clinical assessment, electrophysiological and MRI before, immediately post- and second post-assessments (4 weeks).
A group of 24 healthy subjects will undergo a parallel physiopathological study on the underlying mechanisms of cerebellar PAS Objectives Main objective: To determine whether (and how) Paired Associative Stimulation technique (PAS) induces cerebral reorganization in the primary motor cortex compared to the control group.
Aim 2: Determine whether (and which) type of PAS is capable of inducing changes in motor performance of the upper limb paresis and duration Aim 3: Determine whether (and which) type of PAS is capable of inducing changes in excitability of the corticospinal tract and duration Aim 4: Determine how PAS techniques modify the functional connectivity during movement Aim 5: Determine if connectivity changes during induced movement correlate with clinical improvements Aim 6: Determine whether patients who benefit of a type of PAS have specific anatomical lesion characteristics (volume, afferent and efferent white matter fasciculi integrity) Aim 7: for healthy subjects: determine the TMS parameters that will influence the response to cerebellar PAS protocols
Hypotheses
- The sensorimotor stimulation approach (V_PAS or CER_PAS) improves motor function of the hand compared to the control group. The CER_PAS approach may be more effective than V_PAS as the cerebellum plays a major role in the post-stroke recovery
- This improvement would be explained by an effect on brain reorganization by increasing the proportion of activation in the ipsilesional primary motor cortex comparing to the contralesional side, as well as strengthening the relationships between ipsilesional premotor and motor cortices.
- Clinical and electrophysiological effects observed in the combined approach are correlated with specific characteristics of the sensorimotor network assessed by MRI.
Perspectives Demonstrating beneficial effects would subsequently consider protocols in order to achieve a therapeutic effect in the long term. The low cost greatly facilitates the implementation of feasible treatments in routine care in specialized centers (or pilot research centers) and potentially useful in many patients. The study of the characteristics of responders and non-responders patients would provide "patient-oriented" treatment, which take into account the particularities of each subject.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Charlotte ROSSO, PI
- Número de teléfono: +331 42161854
- Correo electrónico: charlotte.rosso@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Sophie CORIOU, INSERM
- Número de teléfono: +331 42165778
- Correo electrónico: sophie.coriou@inserm.fr
Ubicaciones de estudio
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Paris, Francia, 75013
- Reclutamiento
- ICM, CIC Neurosciences
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria FOR PATIENTS:
- First event ischemic stroke with hand motor deficit
- Time since stroke > 30 days
- Stroke lesion sparing the primary motor cortex (hand knob area)
- Age between 18 and 85 ans
Exclusion Criteria FOR PATIENTS:
- No homonymous hemianopia
- No contra-indications for TMS and MRI
- Pregnancy
- Epilepsia
- Any pathology that threatened the 1 month follow up
Inclusion Criteria FOR HEALTHY SUBJECTS:
- Age between 18 and 85
- Right handed
Exclusion Criteria FOR HEALTHY SUBJECTS
- No contra-indications for TMS and MRI
- Pregnancy
- Any cerebral pathology or pathology that threatened the 1 month follow up
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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V_PAS
Visuomotor paired associative stimulation protocol
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Sham V_PAS
Placebo group of Visuomotor paired associative stimulation protocol
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CER_PAS
cerebellar-motor associative stimulation protocol
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Sham CER_PAS
Placebo group of cerebellar-motor associative stimulation protocol
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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change in lateralization indices in the primary motor cortex using functional magnetic Resonance
Periodo de tiempo: Change from Baseline to day 5 (Pre and post intervention)
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Change from Baseline to day 5 (Pre and post intervention)
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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change in motor score of the affected hand by the Jebsen Taylor Test
Periodo de tiempo: Change from Baseline to day 5 (Pre and post intervention)
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Change from Baseline to day 5 (Pre and post intervention)
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change in corticospinal excitability by the motor evoked potentials
Periodo de tiempo: Change from Baseline to day 5 (Pre and post intervention)
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Change from Baseline to day 5 (Pre and post intervention)
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Charlotte ROSSO, PI, Brain and Spine institute, INSERM UMR 1127, CNRS 7225
Publicaciones y enlaces útiles
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 (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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- C14-38
- 2014-A01165-42 (Identificador de registro: IDBRCB)
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