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Modulation and Assessment of Mental Flexibility in Dysexecutive Brain Patients (MODEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253522
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
ISAE-SUPAERO
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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 (patients)

Condition or disease Intervention/treatment Phase
Dysexecutive Syndrome Behavioral: Cognitive training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: N of 1 Trials with multiple Baseline with 3 phases
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Modulation and Assessment of Mental Flexibility in Dysexecutive Brain Patients
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Arm Intervention/treatment
Experimental: Arm 1 (early phase B)
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
Behavioral: Cognitive training
Rehabilitation program in standard ergotherapy and cognitive training with Covirtua Software and Transcranial random noise stimulation

Experimental: Arm 2 (mid phase B)
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
Behavioral: Cognitive training
Rehabilitation program in standard ergotherapy and cognitive training with Covirtua Software and Transcranial random noise stimulation

Experimental: Arm 3 (late phase B)
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
Behavioral: Cognitive training
Rehabilitation program in standard ergotherapy and cognitive training with Covirtua Software and Transcranial random noise stimulation




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Evolution of performance at GAS (Goal Attainment scaling) in short term [ Time Frame: Just after the cognitive training phase (TF) ]
    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

  2. 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) ]
    Patients performance (reaction time) when performing a battery that assess executive function and attention (TEA battery, Test of Everyday Attention) at each evaluation time

  3. 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) ]
    Patients performance (score) when performing a battery that assess executive function and attention (TEA battery, Test of Everyday Attention) at each evaluation time



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Claustrophobia
  • Addiction
  • Major Hearing or Visual loss
  • Hearing prosthesis
  • Metal intraocular implant
  • Cardiac prosthesis
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253522


Contacts
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Contact: Xavier De Boissezon, MD 33-561322120 deboissezon.xavier@chu-toulouse.fr

Locations
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France
Universty hospital of Toulouse (Rangueil)
Toulouse, France, 31059
Contact: Xavier De Boissezon, MD         
Principal Investigator: Xavier De Boissezon, MD         
Sub-Investigator: Evelyne Castel-Lacanal, MD         
Sponsors and Collaborators
University Hospital, Toulouse
ISAE-SUPAERO
Investigators
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Principal Investigator: Xavier De Boissezon, MD University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04253522    
Other Study ID Numbers: RC31/18/0041
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Cognitive Rehabilitation
Mental flexibility
Ecological tasks
Functional Connectivity
Electroencephalogram
Traumatic Brain Injury
CerebroVascular Accident