Clinical trial NCT03103230: Electro-physiological Signs to Prognostic Aphasia Recovery After a Stroke
Official title: Recherche de Marqueurs Pronostiques électro-physiologiques précoces Chez l'Aphasique après un Accident Vasculaire cérébral.APHA-TMS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Aphasia
Keywords: Motor evoked potentials
aphasia
prognosis
stroke
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evolution of aphasia
timeFrame: 6 months after stroke
Secondary outcomes:
measure: Evolution of aphasia
timeFrame: 3 months after stroke
measure: Pattern of aphasia
timeFrame: 3 & 6 months after stroke
measure: Pattern of aphasia
timeFrame: 3 & 6 months after stroke
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital Bordeaux, France, EA 4136 Univ. Bordeaux, France
name: GLIZE Bertrand, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unité de Soutien Méthodologique à la Recherche Clinique
name: PICAT Quitterie, MD
role: STUDY_CHAIR
References:
citation: Dickey, L., A. Kagan, et al. (2010).
citation: El Hachioui, H., H. F. Lingsma, et al. (2013).
citation: Fadiga L, Craighero L, Buccino G, Rizzolatti G. Speech listening specifically modulates the excitability of tongue muscles: a TMS study. Eur J Neurosci. 2002 Jan;15(2):399-402. doi: 10.1046/j.0953-816x.2001.01874.x.
citation: Meister IG, Wilson SM, Deblieck C, Wu AD, Iacoboni M. The essential role of premotor cortex in speech perception. Curr Biol. 2007 Oct 9;17(19):1692-6. doi: 10.1016/j.cub.2007.08.064. Epub 2007 Sep 27.
citation: Meister IG, Sparing R, Foltys H, Gebert D, Huber W, Topper R, Boroojerdi B. Functional connectivity between cortical hand motor and language areas during recovery from aphasia. J Neurol Sci. 2006 Sep 25;247(2):165-8. doi: 10.1016/j.jns.2006.04.003. Epub 2006 Jun 5.
citation: Meister IG, Buelte D, Staedtgen M, Boroojerdi B, Sparing R. The dorsal premotor cortex orchestrates concurrent speech and fingertapping movements. Eur J Neurosci. 2009 May;29(10):2074-82. doi: 10.1111/j.1460-9568.2009.06729.x. Epub 2009 May 9.
citation: Tokimura H, Tokimura Y, Oliviero A, Asakura T, Rothwell JC. Speech-induced changes in corticospinal excitability. Ann Neurol. 1996 Oct;40(4):628-34. doi: 10.1002/ana.410400413.