NCT03103230

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
1 year until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
Last Updated

April 6, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

January 15, 2015

Last Update Submit

March 31, 2017

Conditions

StrokeAphasia

Keywords

Motor evoked potentialsaphasiaprognosisstroke

Outcome Measures

Primary Outcomes (1)

  • Evolution of aphasia

    Aphasia Severity Rating Scale (ASRS)

    6 months after stroke

Secondary Outcomes (3)

  • Evolution of aphasia

    3 months after stroke

  • Pattern of aphasia

    3 & 6 months after stroke

  • Pattern of aphasia

    3 & 6 months after stroke

Study Arms (1)

Motor Evoked Potentials

EXPERIMENTAL

Patients with aphasia after a stroke

Device: Cortical magnetic stimulation

Interventions

Cortical magnetic stimulationDEVICE

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

Motor Evoked Potentials

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

Location

Related Publications (7)

  • Dickey, L., A. Kagan, et al. (2010).

    RESULT

  • El Hachioui, H., H. F. Lingsma, et al. (2013).

    RESULT

  • 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.

    PMID: 11849307RESULT

  • 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.

    PMID: 17900904RESULT

  • 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.

    PMID: 16737714RESULT

  • 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.

    PMID: 19453637RESULT

  • 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.

    PMID: 8871583RESULT

MeSH Terms

Conditions

StrokeAphasia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • GLIZE Bertrand, MD

    University Hospital Bordeaux, France, EA 4136 Univ. Bordeaux, France

    PRINCIPAL INVESTIGATOR

  • PICAT Quitterie, MD

    Unité de Soutien Méthodologique à la Recherche Clinique

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2015

First Posted

April 6, 2017

Study Start

April 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 6, 2017

Record last verified: 2017-03

Locations

FR(1)