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

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)

Study Overview

• Status: Terminated
• Conditions: Dysexecutive Syndrome
• Intervention / Treatment: Behavioral: Cognitive training

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xavier De Boissezon, MD; Phone Number: 33-561322120; Email: deboissezon.xavier@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Universty hospital of Toulouse (Rangueil)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The month following the cognitive training phase (TF+1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	Before the cognitive training phase (T0), just after the cognitive training phase (TF) and the month following the cognitive training phase (TF+1)

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: ISAE-SUPAERO
• Investigators: Principal Investigator: Xavier De Boissezon, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2020
• Primary Completion (Actual): December 13, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Electroencephalogram; Cognitive Rehabilitation; Traumatic Brain Injury; Functional Connectivity; Mental flexibility; Ecological tasks; CerebroVascular Accident
• Other Study ID Numbers: RC31/18/0041

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No