Modulation and Assessment of Mental Flexibility in Dysexecutive Brain Patients

NCT ID: NCT04253522

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-04
• Study Completion Date: 2022-12-13

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)

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Cognitive training

Intervention Type: BEHAVIORAL

Rehabilitation program in standard ergotherapy and cognitive training with Covirtua Software and Transcranial random noise stimulation

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

Group Type: EXPERIMENTAL

Cognitive training

Intervention Type: BEHAVIORAL

Rehabilitation program in standard ergotherapy and cognitive training with Covirtua Software and Transcranial random noise stimulation

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

Group Type: EXPERIMENTAL

Cognitive training

Intervention Type: BEHAVIORAL

Rehabilitation program in standard ergotherapy and cognitive training with Covirtua Software and Transcranial random noise stimulation

Interventions

Cognitive training

Rehabilitation program in standard ergotherapy and cognitive training with Covirtua Software and Transcranial random noise stimulation

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ISAE-SUPAERO

UNKNOWN

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xavier De Boissezon, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Universty hospital of Toulouse (Rangueil)

Toulouse, , France

Countries

France

Other Identifiers

RC31/18/0041

Identifier Type: -

Identifier Source: org_study_id