Electro-physiological Signs to Prognostic Aphasia Recovery After a Stroke (APHA-TMS)
Primary Purpose
Stroke, Aphasia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cortical magnetic stimulation
Sponsored by
About this trial
This is an interventional other trial for Stroke focused on measuring Motor evoked potentials, aphasia, prognosis, stroke
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.
Sites / Locations
- CHU de Bordeaux
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Motor Evoked Potentials
Arm Description
Patients with aphasia after a stroke
Outcomes
Primary Outcome Measures
Evolution of aphasia
Aphasia Severity Rating Scale (ASRS)
Secondary Outcome Measures
Evolution of aphasia
Aphasia Severity Rating Scale Score (ASRS)
Pattern of aphasia
Boston Diagnostic Aphasia Examination (BDAE) ;
Pattern of aphasia
Language Screening Test (LAST b)
Full Information
NCT ID
NCT03103230
First Posted
January 15, 2015
Last Updated
March 31, 2017
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT03103230
Brief Title
Electro-physiological Signs to Prognostic Aphasia Recovery After a Stroke
Acronym
APHA-TMS
Official Title
Recherche de Marqueurs Pronostiques électro-physiologiques précoces Chez l'Aphasique après un Accident Vasculaire cérébral.APHA-TMS
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Aphasia
Keywords
Motor evoked potentials, aphasia, prognosis, stroke
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Motor Evoked Potentials
Arm Type
Experimental
Arm Description
Patients with aphasia after a stroke
Intervention Type
Device
Intervention Name(s)
Cortical magnetic stimulation
Intervention Description
Motor Evoked Potentials of lips and hand recorded after cortical magnetic stimulation
Primary Outcome Measure Information:
Title
Evolution of aphasia
Description
Aphasia Severity Rating Scale (ASRS)
Time Frame
6 months after stroke
Secondary Outcome Measure Information:
Title
Evolution of aphasia
Description
Aphasia Severity Rating Scale Score (ASRS)
Time Frame
3 months after stroke
Title
Pattern of aphasia
Description
Boston Diagnostic Aphasia Examination (BDAE) ;
Time Frame
3 & 6 months after stroke
Title
Pattern of aphasia
Description
Language Screening Test (LAST b)
Time Frame
3 & 6 months after stroke
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GLIZE Bertrand, MD
Organizational Affiliation
University Hospital Bordeaux, France, EA 4136 Univ. Bordeaux, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
PICAT Quitterie, MD
Organizational Affiliation
Unité de Soutien Méthodologique à la Recherche Clinique
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
12. IPD Sharing Statement
Citations:
Citation
Dickey, L., A. Kagan, et al. (2010).
Results Reference
result
Citation
El Hachioui, H., H. F. Lingsma, et al. (2013).
Results Reference
result
PubMed Identifier
11849307
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.
Results Reference
result
PubMed Identifier
17900904
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.
Results Reference
result
PubMed Identifier
16737714
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.
Results Reference
result
PubMed Identifier
19453637
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.
Results Reference
result
PubMed Identifier
8871583
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.
Results Reference
result
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Electro-physiological Signs to Prognostic Aphasia Recovery After a Stroke
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