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

Institut National de la Santé Et de la Recherche Médicale, France

Status: Terminated

Conditions: Stroke; Aphasia

Treatments: Device: eldith DC-stimulator, configuration T5C; Device: eldith DC-stimulator, configuration T5A; Device: eldith DC-stimulator, configuration F7C; Device: eldith DC-stimulator, configuration F7A; Device: eldith DC-stimulator, configuration Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT02101398

C12-09

2013-A00989-36 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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5 participants in 5 patient groups

F7A

Experimental group

Description:

Anodal electrode set on the left Broca's area and cathodal electrode set on its right homologue. Active stimulation.

Treatment:

Device: eldith DC-stimulator, configuration F7A

F7C

Experimental group

Description:

Cathodal electrode set on the left Broca's area and anodal electrode set on its right homologue. Active stimulation.

Treatment:

Device: eldith DC-stimulator, configuration F7C

T5A

Experimental group

Description:

Anodal electrode set on the left Wernicke's area and cathodal electrode set on its right homologue. Active stimulation.

Treatment:

Device: eldith DC-stimulator, configuration T5A

T5C

Experimental group

Description:

Cathodal electrode set on the left Wernicke's area and anodal electrode set on its right homologue. Active stimulation.

Treatment:

Device: eldith DC-stimulator, configuration T5C

Sham

Sham Comparator group

Description:

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.

Treatment:

Device: eldith DC-stimulator, configuration Sham