Study Stopped
Low inclusion rate
Study of the Effect of Transcranial Stimulations in Aphasic Subject Within a Year of Their Stroke
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
2 other identifiers
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2014
CompletedFirst Posted
Study publicly available on registry
April 2, 2014
CompletedStudy Start
First participant enrolled
October 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedSeptember 4, 2025
August 1, 2021
1.7 years
March 21, 2014
August 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of improvement of picture naming
Before stimulation and immediately after stimulation
Study Arms (5)
F7A
EXPERIMENTALAnodal electrode set on the left Broca's area and cathodal electrode set on its right homologue. Active stimulation.
F7C
EXPERIMENTALCathodal electrode set on the left Broca's area and anodal electrode set on its right homologue. Active stimulation.
T5A
EXPERIMENTALAnodal electrode set on the left Wernicke's area and cathodal electrode set on its right homologue. Active stimulation.
T5C
EXPERIMENTALCathodal electrode set on the left Wernicke's area and anodal electrode set on its right homologue. Active stimulation.
Sham
SHAM COMPARATORElectrodes 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.
Interventions
tDCS will be delivered during a 20 minutes speech-language therapy session
tDCS will be delivered during a 20 minutes speech-language therapy session
tDCS will be delivered during a 20 minutes speech-language therapy session
tDCS will be delivered during a 20 minutes speech-language therapy session
Sham tDCS will be delivered during a 20 minutes speech-language therapy session
Eligibility Criteria
You may qualify if:
- man or woman of 18 years and older
- aphasic patient following a first left hemispheric stroke
- BDAE 3.0 aphasia score \> or = to 1
- mother tongue = French
- right handedness
- signed informed consent
You may not qualify if:
- history of other neurologic pathologies
- dementia
- bilingual patient (2 mother tongues)
- history of cranial surgery
- presence of intracerebral metallic material
- pregnant, parturient or lactating woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Raymond Poincaré
Garches, 92380, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas ROCHE, MD
Hôpital Raymond Poincaré
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2014
First Posted
April 2, 2014
Study Start
October 2, 2014
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
September 4, 2025
Record last verified: 2021-08