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

Not Applicable

Completed

• Conditions: Stroke; Aphasia
• Interventions: Device: eldith DC-stimulator, configuration F7A; Device: eldith DC-stimulator, configuration T5A; Device: eldith DC-stimulator, configuration T5C; Device: eldith DC-stimulator, configuration Sham; Device: eldith DC-stimulator, configuration F7C

• Registration Number: NCT02101398
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

Study Timeline

• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-28
• Study First Posted: 2014-04-02
• Study Start: 2014-10-02
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
F7A	eldith DC-stimulator, configuration F7A	Anodal electrode set on the left Broca's area and cathodal electrode set on its right homologue. Active stimulation.
T5A	eldith DC-stimulator, configuration T5A	Anodal electrode set on the left Wernicke's area and cathodal electrode set on its right homologue. Active stimulation.
T5C	eldith DC-stimulator, configuration T5C	Cathodal electrode set on the left Wernicke's area and anodal electrode set on its right homologue. Active stimulation.
Sham	eldith DC-stimulator, configuration 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.
F7C	eldith DC-stimulator, configuration F7C	Cathodal electrode set on the left Broca's area and anodal electrode set on its right homologue. Active stimulation.

Primary Outcome Measures

Name	Time	Method
Percentage of improvement of picture naming	Before stimulation and immediately after stimulation

Trial Locations

Locations (1)

Hôpital Raymond Poincaré; 🇫🇷 Garches, France