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Completed

NCT Number: NCT03103230

Electro-physiological Signs to Prognostic Aphasia Recovery After a Stroke

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.

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Key information

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cortical magnetic stimulation

Device

Motor Evoked Potentials of lips and hand recorded after cortical magnetic stimulation

Primary outcomes

  1. Evolution of aphasia

    Time frame: 6 months after stroke

    Aphasia Severity Rating Scale (ASRS)

Secondary outcomes

  1. Evolution of aphasia

    Time frame: 3 months after stroke

    Aphasia Severity Rating Scale Score (ASRS)

  2. Pattern of aphasia

    Time frame: 3 & 6 months after stroke

    Boston Diagnostic Aphasia Examination (BDAE) ;

  3. Pattern of aphasia

    Time frame: 3 & 6 months after stroke

    Language Screening Test (LAST b)

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Recherche de Marqueurs Pronostiques électro-physiologiques précoces Chez l'Aphasique après un Accident Vasculaire cérébral.APHA-TMS

Acronym: APHA-TMS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 6, 2017
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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