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

Primary Purpose

Aphasia, Stroke

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

eldith DC-stimulator, configuration F7A

eldith DC-stimulator, configuration F7C

eldith DC-stimulator, configuration T5A

eldith DC-stimulator, configuration T5C

eldith DC-stimulator, configuration Sham

About this trial

This is an interventional treatment trial for Aphasia focused on measuring tDCS, Stroke, Aphasia, Naming

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hôpital Raymond Poincaré

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Sham Comparator

Arm Label

F7A

F7C

T5A

T5C

Sham

Arm Description

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

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

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

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

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.

Outcomes

Primary Outcome Measures

Percentage of improvement of picture naming

Secondary Outcome Measures

Full Information

NCT ID

NCT02101398

First Posted

March 21, 2014

Last Updated

August 25, 2021

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT02101398

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

October 2, 2014 (Actual)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aphasia, Stroke

Keywords

tDCS, Stroke, Aphasia, Naming

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

F7A

Arm Type

Experimental

Arm Description

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

Arm Title

F7C

Arm Type

Experimental

Arm Description

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

Arm Title

T5A

Arm Type

Experimental

Arm Description

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

Arm Title

T5C

Arm Type

Experimental

Arm Description

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

Arm Title

Sham

Arm Type

Sham Comparator

Arm 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.

Intervention Type

Device

Intervention Name(s)

eldith DC-stimulator, configuration F7A

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

eldith DC-stimulator, configuration F7C

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

eldith DC-stimulator, configuration T5A

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

eldith DC-stimulator, configuration T5C

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

eldith DC-stimulator, configuration Sham

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of improvement of picture naming

Time Frame

Before stimulation and immediately after stimulation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolas ROCHE, MD

Organizational Affiliation

Hôpital Raymond Poincaré

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Raymond Poincaré

City

Garches

ZIP/Postal Code

92380

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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