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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-02

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aphasia Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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F7A

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

Group Type EXPERIMENTAL

eldith DC-stimulator, configuration F7A

Intervention Type DEVICE

tDCS will be delivered during a 20 minutes speech-language therapy session

F7C

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

Group Type EXPERIMENTAL

eldith DC-stimulator, configuration F7C

Intervention Type DEVICE

tDCS will be delivered during a 20 minutes speech-language therapy session

T5A

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

Group Type EXPERIMENTAL

eldith DC-stimulator, configuration T5A

Intervention Type DEVICE

tDCS will be delivered during a 20 minutes speech-language therapy session

T5C

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

Group Type EXPERIMENTAL

eldith DC-stimulator, configuration T5C

Intervention Type DEVICE

tDCS will be delivered during a 20 minutes speech-language therapy session

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.

Group Type SHAM_COMPARATOR

eldith DC-stimulator, configuration Sham

Intervention Type DEVICE

Sham tDCS will be delivered during a 20 minutes speech-language therapy session

Interventions

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eldith DC-stimulator, configuration F7A

tDCS will be delivered during a 20 minutes speech-language therapy session

Intervention Type DEVICE

eldith DC-stimulator, configuration F7C

tDCS will be delivered during a 20 minutes speech-language therapy session

Intervention Type DEVICE

eldith DC-stimulator, configuration T5A

tDCS will be delivered during a 20 minutes speech-language therapy session

Intervention Type DEVICE

eldith DC-stimulator, configuration T5C

tDCS will be delivered during a 20 minutes speech-language therapy session

Intervention Type DEVICE

eldith DC-stimulator, configuration Sham

Sham tDCS will be delivered during a 20 minutes speech-language therapy session

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No