Study of the Effect of Transcranial Stimulations in Aphasic Subject Within a Year of Their Stroke

Study Overview
=================
Brief Summary
-----------------
The aim of this work is to study the effect of transcranial direct current stimulation combined with naming therapy in acute and post-acute stroke comparing four bihemispheric positioning electrodes to a sham condition.

Detailed Description
-----------------
TDCS have shown a positive effect on clinical outcome in naming treatment in aphasic subjects however some aspects as the positioning of the electrodes on the head are still unclear. That is why we compare the effects of four different positionings of the electrodes (two anterior over Broca's area and its homologue and two posterior over Wernicke's area and its homologue) to a sham stimulation in order to observe if a more important effect of one or another positioning could be found.

Official Title
-----------------
Etude de l'Effet de Stimulations transcrâniennes en Courant Continu (tDCS) Sur Les Performances en dénomination Chez le Sujet Aphasique à Moins d'un an de Son Accident Vasculaire cérébral : Comparaison de 5 Configurations de Stimulation

Conditions
-----------------
Aphasia, Stroke

Intervention / Treatment
-----------------
* Device: eldith DC-stimulator, configuration F7A
* Device: eldith DC-stimulator, configuration F7C
* Device: eldith DC-stimulator, configuration T5A
* Device: eldith DC-stimulator, configuration T5C
* Device: eldith DC-stimulator, configuration Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: man or woman of 18 years and older aphasic patient following a first left hemispheric stroke BDAE 3.0 aphasia score > or = to 1 stroke within 3 to 12 months before inclusion in the study mother tongue = French right handedness signed informed consent Exclusion Criteria: history of other neurologic pathologies epileptic seizure within 2 months before inclusion dementia bilingual patient (2 mother tongues) history of cranial surgery presence of intracerebral metallic material unauthorized molecules at inclusion : sulpiride, rivastigmine, dextromethorphan, carbamazepine, flunarizine, levodopa pregnant, parturient or lactating woman

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F7A<br>Anodal electrode set on the left Broca's area and cathodal electrode set on its right homologue. Active stimulation. | Device: eldith DC-stimulator, configuration F7A<br>* tDCS will be delivered during a 20 minutes speech-language therapy session<br>|
| Experimental: F7C<br>Cathodal electrode set on the left Broca's area and anodal electrode set on its right homologue. Active stimulation. | Device: eldith DC-stimulator, configuration F7C<br>* tDCS will be delivered during a 20 minutes speech-language therapy session<br>|
| Experimental: T5A<br>Anodal electrode set on the left Wernicke's area and cathodal electrode set on its right homologue. Active stimulation. | Device: eldith DC-stimulator, configuration T5A<br>* tDCS will be delivered during a 20 minutes speech-language therapy session<br>|
| Experimental: T5C<br>Cathodal electrode set on the left Wernicke's area and anodal electrode set on its right homologue. Active stimulation. | Device: eldith DC-stimulator, configuration T5C<br>* tDCS will be delivered during a 20 minutes speech-language therapy session<br>|
| Sham Comparator: Sham<br>Electrodes set on the left Broca's area and its right homologue or electrodes set on the left Wernicke's area and its right homologue, but no stimulation will be delivered. | Device: eldith DC-stimulator, configuration Sham<br>* Sham tDCS will be delivered during a 20 minutes speech-language therapy session<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of improvement of picture naming |  | Before stimulation and immediately after stimulation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Aphasia, Naming, tDCS