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

August 28, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Garches, France, 92380
        • Hopital Raymond Poincare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of improvement of picture naming
Time Frame: Before stimulation and immediately after stimulation
Before stimulation and immediately after stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Nicolas ROCHE, MD, Hopital Raymond Poincare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

March 21, 2014

First Submitted That Met QC Criteria

March 28, 2014

First Posted (Estimated)

April 2, 2014

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 28, 2025

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C12-09
  • 2013-A00989-36 (Registry Identifier: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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