Interest of Combining Speech Therapy With a Non-invasive Brain Stimulation (tDCS) for the Aphasic Patient

Study Overview
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Brief Summary
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Aphasia is a frequent symptom after a left hemisphere stroke. It has serious impacts on social, family and professional lives. Aphasic patients need to be rehabilitated. To date, no pharmacological treatment being available only speech and language therapy (SLT) can improve patients, but its efficiency is moderate. Several studies have investigated the link between the recovery of language and neural reorganization. tDCs, a noninvasive technology for modulating neural excitability, could potentiate the effects of the SLT. About 25 studies in literature have described beneficial effects of tDCs coupled with SLT on aphasic patients. However to the investigator knowledge the feasibility of tDCs and speech therapy in clinical pathways has never been investigated. That is why the investigator propose to study in real care conditions how SLT proves more efficient on the recovery of language in a discursive assessment when coupled with active stimulation than with placebo stimulation.

Detailed Description
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This is a multicenter, cross-over, randomized, controlled and double blind study. 24 patients will be included between November 2015 and November 2017. 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.

Official Title
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Interest of Combining Speech Therapy With a Non-invasive Brain Stimulation (tDCS) for the Aphasic Patient

Conditions
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Aphasia

Intervention / Treatment
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* Procedure: improvement of language for aphasics patients
* Device: Sham tDCS
* Device: tDCs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient more than 18 years 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: Other previous neurological pathologies 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aphasics Patients<br>Patients which have difficulties to speak. Improvement of language for aphasics patients. | Procedure: improvement of language for aphasics patients<br>* Aphasics patients receive active stimulation during SLT<br>Device: tDCs<br> <br> |
| Sham Comparator: Aphasics Patients control<br>Patients which have difficulties to speak will receive Sham tDCS +SLT for aphasics patients control | Procedure: improvement of language for aphasics patients<br>* Aphasics patients receive active stimulation during SLT<br>Device: Sham tDCS<br>* Aphasics patients control receive sham stimulation during SLT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of number of names, without error and not repeated in the speech | The participant must answer a simple question explain me your job or your study. Their production will be recorded and analyzed. For evaluate the stability of participant performances before the stimulation period three based line will be propose. The third base line corresponds to the start of the first stimulation period. After the three week of tdcs coupled with the SLT a new assessment will be realized. One week later begin the new stage of cross over. An assessment will be administered just before and just after the second stimulation period. Then, three follow-up assessments (one all two weeks) will be proposed during one and half month. | Baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| verbal fluency | the participant has two minutes to find the most animal names words beginning by letter p. Investigator collect the number of correct words and calculate the standard deviation according to published norms. | Baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th week. | 
| working memory | the participant repeats the numbers in the same order or inverted order. Investigator collect the highest group of number repeated | baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th week. | 
| visual exploration | a paper with a lot of drawing is presented to the participant. The participant must delete all the bells as fast as possible. Investigator collect the number of bell omissions | baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th week. | 
| every day life scale | a questionnaire is proposed to the participant in order to better understanding how is the communication with their close or with unknown person in a conversation or phone | Baseline measures: start of Week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5 th week, 1 at the beginning of the 7th week, 1 at the end of the 9 th week and 1 at the end of the 10th week. Follow-up measures: 12th, 14th, 16th week. | 
| likert scale | likert scale are proposed to know how the stimulation is tolerated and accepted by the participant, the patient family and the speech therapist. | at the end of the 9 th week, a likert 5 grade scale was proposed. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aphasia, Speaking therapy, Language therapy, transcranial Direct current stimulation