NCT02612753.

Trial name or title	Interest of combining speech therapy [sic]with a non‐invasive brain stimulation (tDCS) for the aphasic patient (Taph)
Methods	Randomised cross‐over trial
Participants	Estimated enrolment: 24 Inclusion criteria: aged above 18 years, aphasia due to a brain injury identified by MRI, 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, proficiency in spoken and written French, affiliated to a social security [sic], signed informed consent Exclusion criteria: other previous neurological pathologies, epileptic crisis during the previous 2 months, presence of a cranial flap, intracerebral metal hardware, patient under guardianship, patient unable to understand the study, patient subject to an exclusion period for another experiment
Interventions	Each participant will undergo the following interventions: ‐ A‐tDCS (2 mA for 20 minutes) for 3 weeks + speech and language therapy ‐ S‐tDCS for 20 minutes for 3 weeks + speech and language therapy
Outcomes	Primary outcome measures: ‐ change of number of names, without error and not repeated in the speech (time frame: baseline measures: start of week 1, 2 and 3. Outcomes measures: 1 assessment at the end of the 5th week, 1 at the beginning of the 7th week, 1 at the end of the 9th week and 1 at the end of the 10th week. Follow‐up measures: 12th, 14th, 16th week) "The participant must answer a simple question "explain to me what your job or your study is". Their response will be recorded and analysed. For evaluate the stability of participant performances before the stimulation period three based line will be propose [sic]. 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 [sic]) will be proposed during one and half month." Secondary outcome measures: ‐ verbal fluency (time frame: baseline measures: start of Week 1, 2 and 3. Outcome measures: 1 assessment at the end of the 5th week, 1 at the beginning of the 7th week, 1 at the end of the 9th week and 1 at the end of the 10th week. Follow‐up measures: 12th, 14th, 16th week) "The participant has 2 minutes to find the most animal names words beginning by letter P [sic]. Investigator collect the number of correct words and calculate the standard deviation according to published norms." ‐ working memory (time frame: baseline measures: start of week 1, 2 and 3. Outcome measures: 1 assessment at the end of the 5th week, 1 at the beginning of the 7th week, 1 at the end of the 9th week and 1 at the end of the 10th week. Follow‐up measures: 12th, 14th, 16th week) "The participant repeats the numbers in the same order or inverted order. Investigator collect the highest group of number repeated" ‐ visual exploration (time frame: baseline measures: start of week 1, 2 and 3. Outcome measures: 1 assessment at the end of the 5th week, 1 at the beginning of the 7th week, 1 at the end of the 9th week and 1 at the end of the 10th week. Follow‐up measures: 12th, 14th, 16th week). "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" ‐ everyday life scale (time frame: baseline measures: start of week 1, 2 and 3. Outcome measures: 1 assessment at the end of the 5th week, 1 at the beginning of the 7th week, 1 at the end of the 9th week and 1 at the end of the 10th week. Follow‐up measures: 12th, 14th, 16th week) "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" [sic] ‐ Likert Scale (time frame: at the end of the 9th week, a Likert 5 grade scale was proposed) "Likert scale are proposed to know how the stimulation is tolerated and accepted by the participant, the patient family and the speech therapist"
Starting date	November 2015
Contact information	Philippe Azouvi, MD,PhD 0033147107074 philippe.azouvi@aphp.fr
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