AphasiaNCT02101398
Study of the Effect of Transcranial Stimulations in Aphasic Subject Within a Year of Their Stroke
A study testing eldith DC-stimulator, configuration F7A, eldith DC-stimulator, configuration F7C and eldith DC-stimulator, configuration T5A in people with Aphasia and Stroke, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- eldith DC-stimulator, configuration F7A, eldith DC-stimulator, configuration F7C and eldith DC-stimulator, configuration T5A
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- 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
- Keywords
- tDCS, Stroke, Aphasia, Naming
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eldith DC-stimulator, configuration F7ADevice
tDCS will be delivered during a 20 minutes speech-language therapy session
eldith DC-stimulator, configuration F7CDevice
tDCS will be delivered during a 20 minutes speech-language therapy session
eldith DC-stimulator, configuration T5ADevice
tDCS will be delivered during a 20 minutes speech-language therapy session
eldith DC-stimulator, configuration T5CDevice
tDCS will be delivered during a 20 minutes speech-language therapy session
eldith DC-stimulator, configuration ShamDevice
Sham tDCS will be delivered during a 20 minutes speech-language therapy session
| Study group | Role | What they receive |
|---|---|---|
| F7A | Experimental | Anodal electrode set on the left Broca's area and cathodal electrode set on its right homologue. Active stimulation. Receives: Device: eldith DC-stimulator, configuration F7A |
| F7C | Experimental | Cathodal electrode set on the left Broca's area and anodal electrode set on its right homologue. Active stimulation. Receives: Device: eldith DC-stimulator, configuration F7C |
| T5A | Experimental | Anodal electrode set on the left Wernicke's area and cathodal electrode set on its right homologue. Active stimulation. Receives: Device: eldith DC-stimulator, configuration T5A |
| T5C | Experimental | Cathodal electrode set on the left Wernicke's area and anodal electrode set on its right homologue. Active stimulation. Receives: Device: eldith DC-stimulator, configuration T5C |
| Sham | Sham comparator | 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. Receives: Device: eldith DC-stimulator, configuration Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of improvement of picture naming
Measured: Before stimulation and immediately after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study start2 Oct 2014
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Low inclusion rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nicolas ROCHE, MD, Principal investigator, Hôpital Raymond Poincaré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101398
- Sponsor's protocol ID
- C12-09
- Other IDs
- 2013-A00989-36
- Status last verified
- Aug 2021
- First submitted
- 21 Mar 2014
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02101398
- Acronym / sponsor ID
- C12-09
- Keywords
- tDCS, Stroke, Aphasia, Naming
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low inclusion rate
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 2 Oct 2014 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| F7A | Experimental | Device: eldith DC-stimulator, configuration F7AAnodal electrode set on the left Broca's area and cathodal electrode set on its right homologue. Active stimulation. |
| F7C | Experimental | Device: eldith DC-stimulator, configuration F7CCathodal electrode set on the left Broca's area and anodal electrode set on its right homologue. Active stimulation. |
| T5A | Experimental | Device: eldith DC-stimulator, configuration T5AAnodal electrode set on the left Wernicke's area and cathodal electrode set on its right homologue. Active stimulation. |
| T5C | Experimental | Device: eldith DC-stimulator, configuration T5CCathodal electrode set on the left Wernicke's area and anodal electrode set on its right homologue. Active stimulation. |
| Sham | Sham comparator | Device: eldith DC-stimulator, configuration ShamElectrodes 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- history of other neurologic pathologies
- epileptic seizure within 2 months before inclusion
- dementia
- bilingual patient (2 mother tongues)
- history of cranial surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eldith DC-stimulator, configuration F7AtDCS will be delivered during a 20 minutes speech-language therapy session | Device | F7A |
| eldith DC-stimulator, configuration F7CtDCS will be delivered during a 20 minutes speech-language therapy session | Device | F7C |
| eldith DC-stimulator, configuration T5AtDCS will be delivered during a 20 minutes speech-language therapy session | Device | T5A |
| eldith DC-stimulator, configuration T5CtDCS will be delivered during a 20 minutes speech-language therapy session | Device | T5C |
| eldith DC-stimulator, configuration ShamSham tDCS will be delivered during a 20 minutes speech-language therapy session | Device | Sham |
Primary outcome
Percentage of improvement of picture naming
Time frame: Before stimulation and immediately after stimulation
Results and safety
The study was stopped early (reason given: Low inclusion rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
Related trials for Aphasia
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Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
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Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
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Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
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Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas ROCHE, MD principal investigator
Hôpital Raymond Poincaré
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eldith DC-stimulator, configuration F7A, eldith DC-stimulator, configuration F7C and eldith DC-stimulator, configuration T5A in people with Aphasia and Stroke, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low inclusion rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of improvement of picture naming (time frame: Before stimulation and immediately after stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.