Traumatic Brain InjuryRemCog-TCNCT02698449
Neurorehabilitation After Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study
A study testing transcranial direct current stimulation, Specific cognitive rehabilitation and Nonspecific cognitive rehabilitation in people with Traumatic Brain Injury, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The current study aims to better understand cerebral plasticity mechanisms to optimize non-pharmacological rehabilitation approaches for patients with traumatic brain injury. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- transcranial direct current stimulation, Specific cognitive rehabilitation and Nonspecific cognitive rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2017to 25 Jun 2025
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Moderate to severe traumatic brain injury
- more than 3 months since the onset
- Attentional disorders (PASAT test (score ≤ centile 10) and/or CANTAB test (≤ -2 standard deviation)
- Women having contraceptive treatment (for the magnetic resonance imaging exam)
Who cannot join
- inability to undergo magnetic resonance imaging scan
- No attentional impairment (PASAT ≥ centile10)
- Severe depression
- Neurological disease
- Major cognitive impairment (aphasia, neglect)
- Drugs addiction
- Pregnant women and women having no contraceptive treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Rehabilitation Combined to Transcranial Direct Current Stimulation Following Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study
The current study aims to better understand cerebral plasticity mechanisms to optimize non-pharmacological rehabilitation approaches for patients with traumatic brain injury.
Read the detailed description
Cognitive impairment following moderate to severe traumatic brain injury are usual. To date, cognitive rehabilitation effects on cerebral plasticity and quality of life remain unproven essentially because of methodological biases. Transcranial Direct Current Stimulation is an innovative technique of noninvasive brain stimulation that showed efficacy in literature. The current study want to better understand cerebral plasticity mechanisms to optimize non-pharmacological rehabilitation approaches for patients with traumatic brain injury. The aim in the present study is to assess the effect of rehabilitation combined with Transcranial Direct Current Stimulation provided to traumatic brain injury patients with cognitive impairment on cerebral plasticity using functional magnetic resonance imaging. Effects of rehabilitation and Transcranial Direct Current Stimulation will be observed on functional magnetic resonance imaging activation maps acquired. Relationship between attentional outcomes measured in the neuropsychological assessment and activation extend will be explored.
- Conditions
- Traumatic Brain Injury
- Being tested
- transcranial direct current stimulation, Specific cognitive rehabilitation, Nonspecific cognitive rehabilitation, transcranial direct current stimulation sham, functional Magnetic Resonance Imaging n-back task
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationProcedure or surgery
intensity provided will be 2 milliampere during 20 minutes using 2 electrodes (7x5cm). Anode electrode will be located on the right prefrontal dorsolateral area; cathode electrode will be located on the left supraorbital area.
Specific cognitive rehabilitationProcedure or surgery
Specific cognitive rehabilitation will be personalized regarding the cognitive complaint and will include a training part and an ecological part.
Nonspecific cognitive rehabilitationProcedure or surgery
Nonspecific cognitive rehabilitation will be focused on representation of body in space.
transcranial direct current stimulation shamProcedure or surgery
the same operation that transcranial direct current stimulating but it is a sham surgery
functional Magnetic Resonance Imaging n-back taskRadiation
the n-back cognitive task was developed : 3 runs will be provided (0-back, 1-back and 2-back), each will be composed of 8 activation blocks and 8 resting blocks alternatively presented.
| Study group | Role | What they receive |
|---|---|---|
| cognitive rehabilitation + transcranial stimulation | Experimental | specific cognitive rehabilitation combined to transcranial direct current stimulation Receives: Procedure: transcranial direct current stimulation; Procedure: Specific cognitive rehabilitation; Radiation: functional Magnetic Resonance Imaging n-back task |
| cognitive rehabilitation + stimulation sham | Experimental | specific cognitive rehabilitation combined to transcranial direct current stimulation sham Receives: Procedure: Specific cognitive rehabilitation; Procedure: transcranial direct current stimulation sham; Radiation: functional Magnetic Resonance Imaging n-back task |
| placebo rehab + transcranial stimulation | Experimental | nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation |
| placebo rehab + stimulation sham | Experimental | nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation sham Receives: Procedure: Nonspecific cognitive rehabilitation; Procedure: transcranial direct current stimulation sham; Radiation: functional Magnetic Resonance Imaging n-back task |
What is being measured
The primary outcome is the main question the study is designed to answer.
intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task).
Measured: 12 weeks
Secondary outcomes (5)
Intergroup differences in resting activation maps.
Measured: 12 weeks
Intergroup differences in diffusion measures
Measured: 12 weeks
Intergroup differences in neuropsychological score
Measured: 12 weeks
Correlation between activation extend and attentional outcomes
Measured: 12 weeks
Intergroup differences in polymorphisms
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study start24 Jan 2017
- Primary completion25 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de l'Avenir
- Responsible party
- Sponsor
- Investigators
- Jérémie Pariente, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698449
- Sponsor's protocol ID
- RC31/14/7328
- Acronym
- RemCog-TC
- Status last verified
- Nov 2026
- First submitted
- 18 Feb 2016
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation Combined to Transcranial Direct Current Stimulation Following Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study
- ClinicalTrials.gov ID
- NCT02698449
- Acronym / sponsor ID
- RemCog-TC / RC31/14/7328
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Fondation de l'Avenir
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 3 Mar 2016 (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 current study aims to better understand cerebral plasticity mechanisms to optimize non-pharmacological rehabilitation approaches for patients with traumatic brain injury.
Detailed description
Cognitive impairment following moderate to severe traumatic brain injury are usual. To date, cognitive rehabilitation effects on cerebral plasticity and quality of life remain unproven essentially because of methodological biases. Transcranial Direct Current Stimulation is an innovative technique of noninvasive brain stimulation that showed efficacy in literature. The current study want to better understand cerebral plasticity mechanisms to optimize non-pharmacological rehabilitation approaches for patients with traumatic brain injury. The aim in the present study is to assess the effect of rehabilitation combined with Transcranial Direct Current Stimulation provided to traumatic brain injury patients with cognitive impairment on cerebral plasticity using functional magnetic resonance imaging. Effects of rehabilitation and Transcranial Direct Current Stimulation will be observed on functional magnetic resonance imaging activation maps acquired. Relationship between attentional outcomes measured in the neuropsychological assessment and activation extend will be explored.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cognitive rehabilitation + transcranial stimulation | Experimental | Procedure: transcranial direct current stimulation, Procedure: Specific cognitive rehabilitation, Radiation: functional Magnetic Resonance Imaging n-back taskspecific cognitive rehabilitation combined to transcranial direct current stimulation |
| cognitive rehabilitation + stimulation sham | Experimental | Procedure: Specific cognitive rehabilitation, Procedure: transcranial direct current stimulation sham, Radiation: functional Magnetic Resonance Imaging n-back taskspecific cognitive rehabilitation combined to transcranial direct current stimulation sham |
| placebo rehab + transcranial stimulation | Experimental | –nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation |
| placebo rehab + stimulation sham | Experimental | Procedure: Nonspecific cognitive rehabilitation, Procedure: transcranial direct current stimulation sham, Radiation: functional Magnetic Resonance Imaging n-back tasknonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation sham |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Moderate to severe traumatic brain injury
- more than 3 months since the onset
- Attentional disorders (PASAT test (score ≤ centile 10) and/or CANTAB test (≤ -2 standard deviation)
- Women having contraceptive treatment (for the magnetic resonance imaging exam)
Key exclusion criteria (7 listed)
- inability to undergo magnetic resonance imaging scan
- No attentional impairment (PASAT ≥ centile10)
- Severe depression
- Neurological disease
- Major cognitive impairment (aphasia, neglect)
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 |
|---|---|---|
| transcranial direct current stimulationintensity provided will be 2 milliampere during 20 minutes using 2 electrodes (7x5cm). Anode electrode will be located on the right prefrontal dorsolateral area; cathode electrode will be located on the left supraorbital area. | Procedure or surgery | cognitive rehabilitation + transcranial stimulation |
| Specific cognitive rehabilitationSpecific cognitive rehabilitation will be personalized regarding the cognitive complaint and will include a training part and an ecological part. | Procedure or surgery | cognitive rehabilitation + stimulation sham, cognitive rehabilitation + transcranial stimulation |
| Nonspecific cognitive rehabilitationNonspecific cognitive rehabilitation will be focused on representation of body in space. | Procedure or surgery | placebo rehab + stimulation sham |
| transcranial direct current stimulation shamthe same operation that transcranial direct current stimulating but it is a sham surgery | Procedure or surgery | cognitive rehabilitation + stimulation sham, placebo rehab + stimulation sham |
| functional Magnetic Resonance Imaging n-back taskthe n-back cognitive task was developed : 3 runs will be provided (0-back, 1-back and 2-back), each will be composed of 8 activation blocks and 8 resting blocks alternatively presented. | Radiation | cognitive rehabilitation + stimulation sham, cognitive rehabilitation + transcranial stimulation, placebo rehab + stimulation sham |
Primary outcome
intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task).
Time frame: 12 weeks
5 secondary outcomes
Intergroup differences in resting activation maps.
Time frame: 12 weeks
Intergroup differences in diffusion measures
Time frame: 12 weeks
Intergroup differences in neuropsychological score
Time frame: 12 weeks
Correlation between activation extend and attentional outcomes
Time frame: 12 weeks
Intergroup differences in polymorphisms
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Jérémie Pariente, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation, Specific cognitive rehabilitation and Nonspecific cognitive rehabilitation in people with Traumatic Brain Injury, run by University Hospital, Toulouse 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 5 Nov 2026. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task). (time frame: 12 weeks). 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 5 Nov 2026.