Electro-physiological Signs to Prognostic Aphasia Recovery After a Stroke (APHA-TMS)
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|ClinicalTrials.gov Identifier: NCT03103230|
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stroke Aphasia||Device: Cortical magnetic stimulation||Not Applicable|
• Background : Stroke affects approximately 130,000 people per year and communication disorders occur in 35% of cases, resulting in left brain damages. Aphasia is the main cause of these disorders. It is a sign of poor prognosis in the functional recovery after stroke. Recent studies have attempted to establish early clinical prognostic criteria to establish a predictive model of aphasia recovery. The issue of the possibility of prediction is important and can influence the rehabilitation treatment decided in the early days after stroke, with adequate guidance in rehabilitation structures.
There are close links between motor system and language, either at production or comprehension, and more particularly concerning the motricity of the hand or lips. The cortical excitability of motor areas of the right upper limb is thus modified by the language in healthy subjects, but also in the aphasic person.
- Purpose : The main: to study, among the aphasic person, if Motor Evoked Potentials (MEP) performed within the first 14 days after a stroke can predict a good recovery from aphasia 6 months of the initial episode.
- Detailed description: All aphasic stroke patients with ischemic or hemorrhagic damages will be proposed for inclusion. All patients will benefit in the acute phase of an aphasia evaluation, and a clinical evaluation. All patients will have a study of motor evoked potentials (abductor pollicis brevis and orbicularis oris) less than 14 days from stroke. The investigators will evaluate the aphasia 3 and 6 months after stroke, to determinate if MEP can predict a good recovery of aphasia.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Recherche de Marqueurs Pronostiques électro-physiologiques précoces Chez l'Aphasique après un Accident Vasculaire cérébral.APHA-TMS|
|Actual Study Start Date :||April 2014|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Experimental: Motor Evoked Potentials
Patients with aphasia after a stroke
Device: Cortical magnetic stimulation
Motor Evoked Potentials of lips and hand recorded after cortical magnetic stimulation
- Evolution of aphasia [ Time Frame: 6 months after stroke ]Aphasia Severity Rating Scale (ASRS)
- Evolution of aphasia [ Time Frame: 3 months after stroke ]Aphasia Severity Rating Scale Score (ASRS)
- Pattern of aphasia [ Time Frame: 3 & 6 months after stroke ]Boston Diagnostic Aphasia Examination (BDAE) ;
- Pattern of aphasia [ Time Frame: 3 & 6 months after stroke ]Language Screening Test (LAST b)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103230
|CHU de Bordeaux|
|Bordeaux, France, 33076|
|Principal Investigator:||GLIZE Bertrand, MD||University Hospital Bordeaux, France, EA 4136 Univ. Bordeaux, France|
|Study Chair:||PICAT Quitterie, MD||Unité de Soutien Méthodologique à la Recherche Clinique|