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

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Overall Status

Completed

CT.gov ID

NCT02101398

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aphasia Stroke	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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 2, 2014

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: F7A 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 tDCS will be delivered during a 20 minutes speech-language therapy session
Experimental: F7C 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 tDCS will be delivered during a 20 minutes speech-language therapy session
Experimental: T5A 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 tDCS will be delivered during a 20 minutes speech-language therapy session
Experimental: T5C 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 tDCS will be delivered during a 20 minutes speech-language therapy session
Sham Comparator: Sham 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 Sham tDCS will be delivered during a 20 minutes speech-language therapy session

Outcome Measures

Primary Outcome Measures

Percentage of improvement of picture naming [Before stimulation and immediately after stimulation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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