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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Stroke Aphasia Device: Cortical magnetic stimulation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Evolution of aphasia [ Time Frame: 6 months after stroke ]
    Aphasia Severity Rating Scale (ASRS)


Secondary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
France
CHU de Bordeaux
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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

Publications of Results:
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03103230     History of Changes
Other Study ID Numbers: CHUBX2013/08
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: March 2017

Keywords provided by University Hospital, Bordeaux:
Motor evoked potentials
aphasia
prognosis
stroke

Additional relevant MeSH terms:
Stroke
Aphasia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms