Head TraumaMeta-SCEDNCT06077695
Cognitive Remediation of Working Memory Post Head Trauma
A study testing therapeutic education, tDCS and cognitive remediation in people with Head Trauma, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Patients with working memory deficits due to a moderate to severe head injury will undergo a 5 month protocol including cognitive remediation with numerous exercises, transcranial direct current stimulation (tDCS), and therapeutic education. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Head Trauma
- What is being tested?
- therapeutic education, tDCS and cognitive remediation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2025to 6 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 or severe head trauma, defined by an initial Glasgow score ≤ 12/15, duration of post-traumatic amnesia superior to 24 hours and/or the presence of abnormalities on brain imaging,
- Moderate or severe head trauma occurring within a period greater than or equal to 3 months,
- Working memory complaints assessed by the Working Memory Questionnaire,
- Patients with a working memory disorder in at least one of the following tests: Digit Memory subtest WAIS-IV (standard deviation ≤ -2) , PASAT (percentile ≤ 10), Brown-Peterson (standard deviation ≤ -2).
Who cannot join
- Presence of aphasia, apraxia or severe neglect demonstrated by standardized neuropsychological tests during the inclusion visit: language - oral naming of BECS-GRECO images, ideational praxis and ideomotor , neglect - bell test,
- Insufficient visual or auditory abilities and oral and written expression to carry out neuropsychological tests,
- Severe depression assessed by the Beck Depression Inventory (BDI)
- Chronic alcoholic poisoning, drug addiction,
- Progressive general illness,
- Progressive psychiatric or neurological condition leading to cognitive impairment,
Show all 9Show fewer
- Hospitalization for a neurological pathology since the acute phase of the qualifying event,
- Patient requiring surgery during study participation.
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Clemence Le Bervet contact
France1 site, 1 recruiting
- Recruiting
UH Toulouse
Toulouse
ADELINE JULIEN, 05 61 77 97 21, julien.ade@CHU-toulouse.fr
About this study
Official title: Cognitive Remediation of Working Memory After Moderate to Severe Head Trauma. a SCED Study.
Patients with working memory deficits due to a moderate to severe head injury will undergo a 5 month protocol including cognitive remediation with numerous exercises, transcranial direct current stimulation (tDCS), and therapeutic education.
Read the detailed description
This study is a multiple baseline Single Case Experimental Design (SCED) across 3 patients and 2 behaviors (working memory performance, application of compensatory strategies).
The remediation program will include 4 intervention phases, and include patients with moderate or severe head trauma and expressing a cognitive complaint of working memory during the neuropsychological screening examination.
These patients will benefit from a neuropsychological assessment at inclusion then cognitive remediation treatment consisting of 4 phases. The duration of the baseline will be randomized. At the end of phases C and D, a new neuropsychological examination will be carried out.
Patients will have to come twice a week, for 12 weeks. All sessions will be individual.
- Phase A: Therapeutic education (Weeks 1 to 4) This first phase will include therapeutic education sessions lasting 90 minutes. The themes covered will concern Head trauma in the chronic phase. Cognitive and behavioral disorders secondary to traumatic brain injury (TBI) will not be addressed. The duration of this phase will be randomized.
- Phase B: tDCS + therapeutic education (Weeks 5 to 8) During this intervention phase, at each visit patients will have 20 minutes of tDCS stimulation and 70 minutes of therapeutic education.
Concerning tDCS stimulation, an electrical current of 2mA will be delivered using the electrodes for 20 min. The content of the therapeutic education sessions will be developed in the same way as for phase A.
- Phase C: tDCS + cognitive remediation (Weeks 9 to 12) During this intervention phase, at each visit, patients will have 20 minutes of tDCS stimulation and 70 minutes of specific cognitive remediation of working memory.
The cognitive remediation program will combine working memory retraining using computerized and paper-and-pencil supports as well as more ecological exercises that respond precisely to the difficulties encountered by the patient in daily life.
- Conditions
- Head Trauma
- Being tested
- therapeutic education, tDCS, cognitive remediation
- Keywords
- working memory, cognitive remediation, transcranial direct current stimulation
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic educationOther
The themes covered concern head trauma in the chronic phase.
tDCSOther
The constant electric current will be delivered at an intensity of 2 mA for 20 minutes.The anode will be placed opposite the dorsolateral prefrontal area on the right. The cathode (or reference electrode) will be positioned opposite the supraorbital area on the left. This methodology is based on the general directions and results from scientific studies which aimed to improve the efficiency of neural networks engaged in attentional processes and working memory.
cognitive remediationOther
Personalized sessions combining 2 approaches:•Retraining deficit components of working memory.exercise the strengthening of metacognition and the learning of "reorganization-facilitation" strategies. At the end of each exercise, the participant will be asked to analyze their performance and will benefit from feedback from the rehabilitator as well as a discussion on the use of the strategies. Finally, all of the proposed tasks will be made up of several levels of complexity; moving to a more complex stage will require more than 90% success in the exercise.•More ecological exercises will also be carried out in order to get as close as possible to the difficulties encountered by the patient on a daily basis. The examiner will guide the rehabilitation and propose tasks imitating his daily life.
| Study group | Role | What they receive |
|---|---|---|
| 4 weeks phase A arm | Experimental | Phase A = Randomised duration of this phase : 4 weeks. each therapeutic therapeutic education sessions last 90 minutes.
Phase B = therapeutic education with tDCS for 4 weeks
Phase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes.
Phase D = follow-up Receives: Other: therapeutic education; Other: tDCS; Other: cognitive remediation |
| 5 weeks phase A arm | Experimental | Phase A = therapeutic education. Randomised duration of this phase : 5 weeks. each therapeutic therapeutic education sessions last 90 minutes.
Phase B = therapeutic education with tDCS for 4 weeks
Phase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes.
Phase D = follow-up Receives: Other: therapeutic education; Other: tDCS; Other: cognitive remediation |
| 6 weeks phase A arm | Experimental | Phase A = therapeutic education. Randomised duration of this phase : 6 weeks. each therapeutic therapeutic education sessions last 90 minutes.
Phase B = therapeutic education with tDCS for 4 weeks
Phase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes.
Phase D = follow-up Receives: Other: therapeutic education; Other: tDCS; Other: cognitive remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working memory performance
difference in performance on a working memory task (2-back) between phase A (therapeutic education) and interventional phase C (t-DCS + cognitive remediation) : a 2-back task is a repeated measure of working memory performance.
On each trial, a stimulus will appear in the center of the screen for 500 msec. It will be followed by an inter-stimulus phase of 1500 msec. The stimulus will be a capital letter (consonants only). In this 2-back task, the subject will be asked to press the answer key as quickly as possible when the letter presented is identical to the penultimate. This task requires strong working memory and attentional resources. Error-free delay (ms), reaction times (ms) and standard deviation of reaction times (ms) will be counted.
Measured: 8 weeks after baseline
Secondary outcomes (1)
Goal attainment
The difference in Goal Attainment Scale (GAS) scores between phase A (therapeutic education) and interventional phase C (t-DCS + cognitive remediation).
Each goal is personalized with the patient.
The scale has 5 types of score each representing a goal attainment status (expectation) :
- 2 being the further away form expectation
- 1 a little less than aimed 0 meaning that the goal set is attained
- 1 a little more than what was aimed
- 2 exceeds a lot expectations
Measured: 8 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start6 Nov 2025
- Primary completion6 Jul 2027 (estimated)
- Study completion6 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head TraumaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Single Case Experimental Design : SCEDs evaluate the effectiveness of an intervention by recruiting a small number of individuals (typically between 1 and 3). They are different from single case studies (or case reports). SCEDs are based on repeated measurements, sequential introduction of the intervention and specific visual and statistical methods of analyzing the results. The strength of SCED lies in the large number of repeated measurements and not in the number of subjects included.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeline Julien, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077695
- Sponsor's protocol ID
- RC31/22/0502
- Acronym
- Meta-SCED
- Status last verified
- Nov 2025
- First submitted
- 4 Oct 2023
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation of Working Memory After Moderate to Severe Head Trauma. a SCED Study.
- ClinicalTrials.gov ID
- NCT06077695
- Acronym / sponsor ID
- Meta-SCED / RC31/22/0502
- Conditions
- Head Trauma
- Keywords
- working memory, cognitive remediation, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 6 Jul 2027 (estimated)
- Study completion
- 6 Jul 2027 (estimated)
- First posted
- 11 Oct 2023 (actual)
- 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.
Patients with working memory deficits due to a moderate to severe head injury will undergo a 5 month protocol including cognitive remediation with numerous exercises, transcranial direct current stimulation (tDCS), and therapeutic education.
Detailed description
This study is a multiple baseline Single Case Experimental Design (SCED) across 3 patients and 2 behaviors (working memory performance, application of compensatory strategies).
The remediation program will include 4 intervention phases, and include patients with moderate or severe head trauma and expressing a cognitive complaint of working memory during the neuropsychological screening examination.
These patients will benefit from a neuropsychological assessment at inclusion then cognitive remediation treatment consisting of 4 phases. The duration of the baseline will be randomized. At the end of phases C and D, a new neuropsychological examination will be carried out.
Patients will have to come twice a week, for 12 weeks. All sessions will be individual.
- Phase A: Therapeutic education (Weeks 1 to 4) This first phase will include therapeutic education sessions lasting 90 minutes. The themes covered will concern Head trauma in the chronic phase. Cognitive and behavioral disorders secondary to traumatic brain injury (TBI) will not be addressed. The duration of this phase will be randomized.
- Phase B: tDCS + therapeutic education (Weeks 5 to 8) During this intervention phase, at each visit patients will have 20 minutes of tDCS stimulation and 70 minutes of therapeutic education.
Concerning tDCS stimulation, an electrical current of 2mA will be delivered using the electrodes for 20 min. The content of the therapeutic education sessions will be developed in the same way as for phase A.
- Phase C: tDCS + cognitive remediation (Weeks 9 to 12) During this intervention phase, at each visit, patients will have 20 minutes of tDCS stimulation and 70 minutes of specific cognitive remediation of working memory.
The cognitive remediation program will combine working memory retraining using computerized and paper-and-pencil supports as well as more ecological exercises that respond precisely to the difficulties encountered by the patient in daily life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Single Case Experimental Design : SCEDs evaluate the effectiveness of an intervention by recruiting a small number of individuals (typically between 1 and 3). They are different from single case studies (or case reports). SCEDs are based on repeated measurements, sequential introduction of the intervention and specific visual and statistical methods of analyzing the results. The strength of SCED lies in the large number of repeated measurements and not in the number of subjects included.
| Arm | Type | Receives |
|---|---|---|
| 4 weeks phase A arm | Experimental | Other: therapeutic education, Other: tDCS, Other: cognitive remediationPhase A = Randomised duration of this phase : 4 weeks. each therapeutic therapeutic education sessions last 90 minutes. Phase B = therapeutic education with tDCS for 4 weeks Phase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes. Phase D = follow-up |
| 5 weeks phase A arm | Experimental | Other: therapeutic education, Other: tDCS, Other: cognitive remediationPhase A = therapeutic education. Randomised duration of this phase : 5 weeks. each therapeutic therapeutic education sessions last 90 minutes. Phase B = therapeutic education with tDCS for 4 weeks Phase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes. Phase D = follow-up |
| 6 weeks phase A arm | Experimental | Other: therapeutic education, Other: tDCS, Other: cognitive remediationPhase A = therapeutic education. Randomised duration of this phase : 6 weeks. each therapeutic therapeutic education sessions last 90 minutes. Phase B = therapeutic education with tDCS for 4 weeks Phase C = Cognitive remediation with tDCS for 4 weeks : Eight specific working memory remediation sessions will be carried out. These will be provided by a neuropsychologist. All cognitive remediation sessions will be individual, biweekly, lasting 1 hour 10 minutes for 4 weeks, for a total duration of 9 hours 20 minutes. Phase D = follow-up |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Moderate or severe head trauma, defined by an initial Glasgow score ≤ 12/15, duration of post-traumatic amnesia superior to 24 hours and/or the presence of abnormalities on brain imaging,
- Moderate or severe head trauma occurring within a period greater than or equal to 3 months,
- Working memory complaints assessed by the Working Memory Questionnaire,
- Patients with a working memory disorder in at least one of the following tests: Digit Memory subtest WAIS-IV (standard deviation ≤ -2) , PASAT (percentile ≤ 10), Brown-Peterson (standard deviation ≤ -2).
Key exclusion criteria (9 listed)
- Presence of aphasia, apraxia or severe neglect demonstrated by standardized neuropsychological tests during the inclusion visit: language - oral naming of BECS-GRECO images, ideational praxis and ideomotor , neglect - bell test,
- Insufficient visual or auditory abilities and oral and written expression to carry out neuropsychological tests,
- Severe depression assessed by the Beck Depression Inventory (BDI)
- Chronic alcoholic poisoning, drug addiction,
- Progressive general illness,
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 |
|---|---|---|
| therapeutic educationThe themes covered concern head trauma in the chronic phase. | Other | 4 weeks phase A arm, 5 weeks phase A arm, 6 weeks phase A arm |
| tDCSThe constant electric current will be delivered at an intensity of 2 mA for 20 minutes.The anode will be placed opposite the dorsolateral prefrontal area on the right. The cathode (or reference electrode) will be positioned opposite the supraorbital area on the left. This methodology is based on the general directions and results from scientific studies which aimed to improve the efficiency of neural networks engaged in attentional processes and working memory. | Other | 4 weeks phase A arm, 5 weeks phase A arm, 6 weeks phase A arm |
| cognitive remediationPersonalized sessions combining 2 approaches:•Retraining deficit components of working memory.exercise the strengthening of metacognition and the learning of "reorganization-facilitation" strategies. At the end of each exercise, the participant will be asked to analyze their performance and will benefit from feedback from the rehabilitator as well as a discussion on the use of the strategies. Finally, all of the proposed tasks will be made up of several levels of complexity; moving to a more complex stage will require more than 90% success in the exercise.•More ecological exercises will also be carried out in order to get as close as possible to the difficulties encountered by the patient on a daily basis. The examiner will guide the rehabilitation and propose tasks imitating his daily life. | Other | 4 weeks phase A arm, 5 weeks phase A arm, 6 weeks phase A arm |
Primary outcome
Working memory performance
Time frame: 8 weeks after baseline
difference in performance on a working memory task (2-back) between phase A (therapeutic education) and interventional phase C (t-DCS + cognitive remediation) : a 2-back task is a repeated measure of working memory performance. On each trial, a stimulus will appear in the center of the screen for 500 msec. It will be followed by an inter-stimulus phase of 1500 msec. The stimulus will be a capital letter (consonants only). In this 2-back task, the subject will be asked to press the answer key as quickly as possible when the letter presented is identical to the penultimate. This task requires strong working memory and attentional resources. Error-free delay (ms), reaction times (ms) and standard deviation of reaction times (ms) will be counted.
1 secondary outcome
Goal attainment
Time frame: 8 weeks after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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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.
Clemence Le Bervet contact
Adeline Julien 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 therapeutic education, tDCS and cognitive remediation in people with Head Trauma, 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 9 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: looking for participants now, as of the sponsor's last update on 7 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adeline Julien (05 61 77 97 21, julien.ade@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Working memory performance (time frame: 8 weeks after baseline). 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 7 Aug 2026.