Electro-physiological Signs to Prognostic Aphasia Recovery After a Stroke (APHA-TMS)

University Hospital of Bordeaux

Status: Completed

Conditions: Stroke; Aphasia

Treatments: Device: Cortical magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03103230

CHUBX2013/08

Details and patient eligibility

About

The purpose of this study is to study, among the aphasic person, if motor function ( studied by Motor Evoked Potentials) performed within the first 14 days after a stroke can predict a good recovery from aphasia 6 months of the initial episode.

Full description

• 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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients with a left stroke (first clinical episode deficit) imaging confirmed.
• With aphasia (-1 language analysis in the acute phase and severity of the questionnaire LAST (Flamand-Roze, Falissard et al. 2011))
• Right-handed (Edinburgh Handedness Inventory)
• Free of dementia before stroke
• Older than 18 years
• French
• Able to hold a sitting in chair.
• Included in maximum 14 days after stroke
• Patient social security system
• Free Consent, informed writing signed by the participant or the person of confidence and the investigator (no later than the day of inclusion and before any examination required by research)

Exclusion criteria

• Refusal of the consent
• Impaired alertness
• Dementia prior to stroke
• Illiteracy
• Severe dysarthria
• Previous psychiatric history requiring hospitalization in a specialized environment for more than two months
• Pregnant
• Major visual or auditory perceptual disorder
• Previous epilepsy or seizures in hyperacute phase of stroke
• Treatment strongly interacting with GABAergic or glutamatergic system
• Contraindication to MEP: clip intracranial ferromagnetic pacemakers, cochlear implant, intracerebral stimulator.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

Motor Evoked Potentials

Experimental group

Description:

Patients with aphasia after a stroke

Treatment:

Device: Cortical magnetic stimulation