Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fondation Paul Bennetot | OTHER |
| Fondation Garches | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aphasics Patients | Experimental | Patients which have difficulties to speak. Improvement of language for aphasics patients. |
|
| Aphasics Patients control | Sham Comparator | Patients which have difficulties to speak will receive Sham tDCS +SLT for aphasics patients control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| improvement of language for aphasics patients | Procedure | Aphasics patients receive active stimulation during SLT |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe AZOUVI, MDPHD | Contact | 0033147107074 | philippe.azouvi@aphp.fr | |
| Nicolas ROCHE, MD | Contact | 0033147107900 | roche.nicolas@rpc.aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Philippe AZOUVI, MDPHD | Hopital RAYMOND POINCARE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Raymond Poincare | Recruiting | Garches | Garches | 92380 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10796360 | Result | 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. | |
| 10990547 | Result | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001037 | Aphasia |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham tDCS | Device | Aphasics patients control receive sham stimulation during SLT |
|
| tDCs | Device |
|
| 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. |
| 25929694 | Result | 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. |
| 9493743 | Result | 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. |
| 23108446 | Result | 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. |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |