Electro-physiological Signs to Prognostic Aphasia Recovery After a Stroke

Stroke Clinical Trial

— APHA-TMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103230
• Other study ID #: CHUBX2013/08
• Status: Completed
• Phase: N/A
• First received: January 15, 2015
• Last updated: March 31, 2017
• Start date: April 2014
• Est. completion date: April 2016

Study information

• Verified date: March 2017
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia
• Stroke

Intervention

Device:
• Cortical magnetic stimulation
Motor Evoked Potentials of lips and hand recorded after cortical magnetic stimulation

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (7)

Dickey L, Kagan A, Lindsay MP, Fang J, Rowland A, Black S. Incidence and profile of inpatient stroke-induced aphasia in Ontario, Canada. Arch Phys Med Rehabil. 2010 Feb;91(2):196-202. doi: 10.1016/j.apmr.2009.09.020. — View Citation

El Hachioui H, Lingsma HF, van de Sandt-Koenderman MW, Dippel DW, Koudstaal PJ, Visch-Brink EG. Long-term prognosis of aphasia after stroke. J Neurol Neurosurg Psychiatry. 2013 Mar;84(3):310-5. doi: 10.1136/jnnp-2012-302596. Epub 2012 Oct 31. — View 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. — View 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. — View Citation

Meister IG, Sparing R, Foltys H, Gebert D, Huber W, Töpper 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of aphasia	Aphasia Severity Rating Scale (ASRS)	6 months after stroke
Secondary	Evolution of aphasia	Aphasia Severity Rating Scale Score (ASRS)	3 months after stroke
Secondary	Pattern of aphasia	Boston Diagnostic Aphasia Examination (BDAE) ;	3 & 6 months after stroke
Secondary	Pattern of aphasia	Language Screening Test (LAST b)	3 & 6 months after stroke