Interest of Combining Speech Therapy With a Non-invasive Brain Stimulation (tDCS) for the Aphasic Patient
NCT ID: NCT02612753
Last Updated: 2016-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2015-11-30
2018-10-31
Brief Summary
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Detailed Description
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During each session of speech and language treatment, aphasics will receive a weak 2 milli amperes (electric) current delivered by a tDCs device for 20 minutes. The stimulation will be either active or placebo. Each stage of the cross over will last three weeks. Patients will be administered the usual number of SLT sessions, no particular therapy being imposed. To evaluate the long-time effects of the therapy, three follow-up measures will be proposed.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Aphasics Patients
Patients which have difficulties to speak. Improvement of language for aphasics patients.
improvement of language for aphasics patients
Aphasics patients receive active stimulation during SLT
tDCs
Aphasics Patients control
Patients which have difficulties to speak will receive Sham tDCS +SLT for aphasics patients control
improvement of language for aphasics patients
Aphasics patients receive active stimulation during SLT
Sham tDCS
Aphasics patients control receive sham stimulation during SLT
Interventions
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improvement of language for aphasics patients
Aphasics patients receive active stimulation during SLT
Sham tDCS
Aphasics patients control receive sham stimulation during SLT
tDCs
Eligibility Criteria
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Inclusion Criteria
* Aphasic Following a brain injury identified by MRI.
* Present a aphasia severity score\> 1 on the Boston Diagnostic Aphasia Examination (BDAE) severity scale.
* No Post stroke delay is retained but the patient should be stable from a medical point of view.
* Master Of the French language in spoken and written
* Affiliated to a social security
* Patient Who signed the informed consent
Exclusion Criteria
* epileptic crisis during the previous 2 months
* Patient denies
* Presence of a cranial flap
* intracerebral metal hardware Presence
* Patient under guardianship
* Patient unable to understand the study
* Patient subject to an exclusion period for another search.
18 Years
ALL
No
Sponsors
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Fondation Paul Bennetot
OTHER
Fondation Garches
OTHER
Centre d'Investigation Clinique et Technologique 805
OTHER
Responsible Party
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AZOUVI
MDPHD
Principal Investigators
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Philippe AZOUVI, MDPHD
Role: PRINCIPAL_INVESTIGATOR
Hopital RAYMOND POINCARE
Locations
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Hopital Raymond Poincare
Garches, Garches, France
Countries
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Central Contacts
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Facility Contacts
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References
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Greener J, Enderby P, Whurr R. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2000;(2):CD000425. doi: 10.1002/14651858.CD000425.
Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving aphasia in patients with aphasia after stroke. Cochrane Database Syst Rev. 2015 May 1;(5):CD009760. doi: 10.1002/14651858.CD009760.pub3.
Robey RR. A meta-analysis of clinical outcomes in the treatment of aphasia. J Speech Lang Hear Res. 1998 Feb;41(1):172-87. doi: 10.1044/jslhr.4101.172.
Klippi A, Sellman J, Heikkinen P, Laine M. Current clinical practices in Aphasia Therapy in Finland: challenges in moving towards national best practice. Folia Phoniatr Logop. 2012;64(4):169-78. doi: 10.1159/000341106. Epub 2012 Oct 25.
Other Identifiers
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2014-A01773-44
Identifier Type: -
Identifier Source: org_study_id
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