Dysexecutive SyndromeMODEXNCT04253522
Modulation and Assessment of Mental Flexibility in Dysexecutive Brain Patients
A study testing Cognitive training in people with Dysexecutive Syndrome, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This project aims to (1) define and characterize brain networks of cognitive flexibility amongst patients with frontal lesions; (2) quantify the effects of ecological cognitive trainings and brain stimulation on behavioral performance and brain networks; (3) identify predictive markers of effective rehabilitation… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Dysexecutive Syndrome
- What is being tested?
- Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2020to 13 Dec 2022
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Affiliated to social security
- Signed informed consent
- Mother tongue: French
- Right handed (Edimburg Scale)
- Frontal traumatic brain injury or stroke responsible for a dysexecutive syndrome assessed by the GREFEX battery.
Who cannot join
- Claustrophobia
- Addiction
- Major Hearing or Visual loss
- Hearing prosthesis
- Metal intraocular implant
- Cardiac prosthesis
Show all 18Show fewer
- High Blood pressure
- Severe cardiac insufficiency
- Uncompensated thyroid disorders
- Major neuropsychological disorder
- Family or personal history of epilepsy
- Pregnancy
- Female subject of childbearing age not receiving effective contraception.
- Participation in another experimental protocol involving brain stimulation within the last 4 weeks
- Person under the protection of justice, tutorship or curatorship
- MRI contraindication
- Refusal to be informed of a new anomaly detected during the MRI examination
- Other traumatic brain injury or neuropsychological disorder
Trial locations and contacts
1 site in 1 country.
About this study
This project aims to (1) define and characterize brain networks of cognitive flexibility amongst patients with frontal lesions; (2) quantify the effects of ecological cognitive trainings and brain stimulation on behavioral performance and brain networks; (3) identify predictive markers of effective rehabilitation (patients)
Read the detailed description
Decision making impairments and perseveration are frequently observed in patients with frontal lobe lesions, associated with overall chronic and serious deficits in executive functions. In order to improve mental flexibility, patients can benefit from reeducation based on regular training of executive functions along with a non-invasive brain stimulation. One of the key areas for such processing is the prefrontal cortex. Previous studies have shown however that maintaining a good level of mental flexibility in complex tasks involves a dynamic integration of several brain areas distributed in large networks. These areas in cooperation can be solicited by a multi-modal intervention such as motor-cognitive tasks associated with a transcranial stimulation. The goal of the present project is to develop a new rehabilitation program and to assess its impact in comparison with current programs. The investigators will also develop new methods to measure long term cerebral modifications induced by these programs. This goal will be reached by: 1) the identification of the brain networks of mental flexibility. 2) The assessment of multimodal task effects associated with or without a transcranial brain stimulation. Behavioral (performance in executive tasks) and functional (parameters of cerebral functional connectivity networks at rest) measures will be used. 3) The identification of mental flexibility predictors. The goal will be to find which initial individual's parameters of brain functional connectivity at rest could predict an optimal level of mental flexibility after training. This project aims at improving the quality of life in the brain-damaged population; impact that could eventually extend to the other parts of the population.
- Conditions
- Dysexecutive Syndrome
- Being tested
- Cognitive training
- Keywords
- Cognitive Rehabilitation, Mental flexibility, Ecological tasks, Functional Connectivity, Electroencephalogram, Traumatic Brain Injury, CerebroVascular Accident
- Medical subject headings
- Brain Injuries, Traumatic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
Rehabilitation program in standard ergotherapy and cognitive training with Covirtua Software and Transcranial random noise stimulation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (early phase B) | Experimental | 3 phases of cognitive training: Phase A1: rehabilitation program in standard ergotherapy during 3 weeks Phase B: cognitive training using Covirtua software and Transcranial random noise stimulation during 4 weeks Phase A2: return to the standard rehabilitation program in standard ergotherapy during 5 weeks Receives: Behavioral: Cognitive training |
| Arm 2 (mid phase B) | Experimental | 3 phases of cognitive training: Phase A1: rehabilitation program in standard ergotherapy during 4 weeks Phase B: cognitive training using Covirtua software and Transcranial random noise stimulation during 4 weeks Phase A2: return to the standard rehabilitation program in standard ergotherapy during 4 weeks Receives: Behavioral: Cognitive training |
| Arm 3 (late phase B) | Experimental | 3 phases of cognitive training: Phase A1: rehabilitation program in standard ergotherapy during 5 weeks Phase B: cognitive training using Covirtua software and Transcranial random noise stimulation during 4 weeks Phase A2: return to the standard rehabilitation program in standard ergotherapy during 3 weeks Receives: Behavioral: Cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of performance at GAS (Goal Attainment scaling) in long term
The main judgement criterion will be the evolution of performance at GAS (Goal Attainment Scaling) in the month following the cognitive training phase, according to the individual objectives defined at the beginning of the procedure with each patient, compared to the baseline phase
Measured: The month following the cognitive training phase (TF+1)
Secondary outcomes (3)
Evolution of performance at GAS (Goal Attainment scaling) in short term
Patients performance will be assessed in an ecological situation after completion of the cognitive training program (short term): by comparing performances at GAS before and during the cognitive training phase
Measured: Just after the cognitive training phase (TF)
Reaction time when performing TEA battery: Test of Everyday Attention
Patients performance (reaction time) when performing a battery that assess executive function and attention (TEA battery, Test of Everyday Attention) at each evaluation time
Measured: Before the cognitive training phase (T0), just after the cognitive training phase (TF) and the month following the cognitive training phase (TF+1)
Score at TEA battery: Test of Everyday Attention
Patients performance (score) when performing a battery that assess executive function and attention (TEA battery, Test of Everyday Attention) at each evaluation time
Measured: Before the cognitive training phase (T0), just after the cognitive training phase (TF) and the month following the cognitive training phase (TF+1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start4 Feb 2020
- Primary completion13 Dec 2022
- Study completion13 Dec 2022
Why it stopped: terminated with16 included patients instead of 18
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysexecutive SyndromeStudies 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
- Model description
- N of 1 Trials with multiple Baseline with 3 phases
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- ISAE-SUPAERO
- Responsible party
- Sponsor
- Investigators
- Xavier De Boissezon, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253522
- Sponsor's protocol ID
- RC31/18/0041
- Acronym
- MODEX
- Status last verified
- Jul 2023
- First submitted
- 31 Jan 2020
- Last updated
- 19 Jul 2023
- 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 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation and Assessment of Mental Flexibility in Dysexecutive Brain Patients
- ClinicalTrials.gov ID
- NCT04253522
- Acronym / sponsor ID
- MODEX / RC31/18/0041
- Conditions
- Dysexecutive Syndrome
- Keywords
- Cognitive Rehabilitation, Mental flexibility, Ecological tasks, Functional Connectivity, Electroencephalogram, Traumatic Brain Injury, CerebroVascular Accident
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated with16 included patients instead of 18
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- ISAE-SUPAERO
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 5 Feb 2020 (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.
This project aims to (1) define and characterize brain networks of cognitive flexibility amongst patients with frontal lesions; (2) quantify the effects of ecological cognitive trainings and brain stimulation on behavioral performance and brain networks; (3) identify predictive markers of effective rehabilitation (patients)
Detailed description
Decision making impairments and perseveration are frequently observed in patients with frontal lobe lesions, associated with overall chronic and serious deficits in executive functions. In order to improve mental flexibility, patients can benefit from reeducation based on regular training of executive functions along with a non-invasive brain stimulation. One of the key areas for such processing is the prefrontal cortex. Previous studies have shown however that maintaining a good level of mental flexibility in complex tasks involves a dynamic integration of several brain areas distributed in large networks. These areas in cooperation can be solicited by a multi-modal intervention such as motor-cognitive tasks associated with a transcranial stimulation. The goal of the present project is to develop a new rehabilitation program and to assess its impact in comparison with current programs. The investigators will also develop new methods to measure long term cerebral modifications induced by these programs. This goal will be reached by: 1) the identification of the brain networks of mental flexibility. 2) The assessment of multimodal task effects associated with or without a transcranial brain stimulation. Behavioral (performance in executive tasks) and functional (parameters of cerebral functional connectivity networks at rest) measures will be used. 3) The identification of mental flexibility predictors. The goal will be to find which initial individual's parameters of brain functional connectivity at rest could predict an optimal level of mental flexibility after training. This project aims at improving the quality of life in the brain-damaged population; impact that could eventually extend to the other parts of the population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- N of 1 Trials with multiple Baseline with 3 phases
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (early phase B) | Experimental | Behavioral: Cognitive training3 phases of cognitive training: Phase A1: rehabilitation program in standard ergotherapy during 3 weeks Phase B: cognitive training using Covirtua software and Transcranial random noise stimulation during 4 weeks Phase A2: return to the standard rehabilitation program in standard ergotherapy during 5 weeks |
| Arm 2 (mid phase B) | Experimental | Behavioral: Cognitive training3 phases of cognitive training: Phase A1: rehabilitation program in standard ergotherapy during 4 weeks Phase B: cognitive training using Covirtua software and Transcranial random noise stimulation during 4 weeks Phase A2: return to the standard rehabilitation program in standard ergotherapy during 4 weeks |
| Arm 3 (late phase B) | Experimental | Behavioral: Cognitive training3 phases of cognitive training: Phase A1: rehabilitation program in standard ergotherapy during 5 weeks Phase B: cognitive training using Covirtua software and Transcranial random noise stimulation during 4 weeks Phase A2: return to the standard rehabilitation program in standard ergotherapy during 3 weeks |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Affiliated to social security
- Signed informed consent
- Mother tongue: French
- Right handed (Edimburg Scale)
- Frontal traumatic brain injury or stroke responsible for a dysexecutive syndrome assessed by the GREFEX battery.
Key exclusion criteria (18 listed)
- Claustrophobia
- Addiction
- Major Hearing or Visual loss
- Hearing prosthesis
- Metal intraocular implant
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 |
|---|---|---|
| Cognitive trainingRehabilitation program in standard ergotherapy and cognitive training with Covirtua Software and Transcranial random noise stimulation | Behavioural | Arm 1 (early phase B), Arm 2 (mid phase B), Arm 3 (late phase B) |
Primary outcome
Evolution of performance at GAS (Goal Attainment scaling) in long term
Time frame: The month following the cognitive training phase (TF+1)
The main judgement criterion will be the evolution of performance at GAS (Goal Attainment Scaling) in the month following the cognitive training phase, according to the individual objectives defined at the beginning of the procedure with each patient, compared to the baseline phase
3 secondary outcomes
Evolution of performance at GAS (Goal Attainment scaling) in short term
Time frame: Just after the cognitive training phase (TF)
Reaction time when performing TEA battery: Test of Everyday Attention
Time frame: Before the cognitive training phase (T0), just after the cognitive training phase (TF) and the month following the cognitive training phase (TF+1)
Score at TEA battery: Test of Everyday Attention
Time frame: Before the cognitive training phase (T0), just after the cognitive training phase (TF) and the month following the cognitive training phase (TF+1)
Results and safety
The study was stopped early (reason given: terminated with16 included patients instead of 18). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
Related trials for Dysexecutive Syndrome
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Home-based Brain Stimulation Treatment for Post-acute Sequelae of COVID-19 (PASC)
Dysexecutive Syndrome, Post-Acute Sequelae of COVID-19
RecruitingObservational study
Study for the Quantification in Ecological Conditions of Sensorimotor and Dysexecutive Disorders in Cerebral Palsy Patients
Dysexecutive Syndrome
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.
Xavier De Boissezon, MD 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 Cognitive training in people with Dysexecutive Syndrome, 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 5 inclusion and 18 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 19 Jul 2023. 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 was stopped early (reason given: terminated with16 included patients instead of 18). 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?
Evolution of performance at GAS (Goal Attainment scaling) in long term (time frame: The month following the cognitive training phase (TF+1)). 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 19 Jul 2023.