Modulation and Assessment of Mental Flexibility in Dysexecutive Brain Patients

NCT04253522 | Terminated

• 1 other identifier: RC31/18/0041
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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)

Conditions

Dysexecutive Syndrome

Keywords

Cognitive Rehabilitation; Mental flexibility; Ecological tasks; Functional Connectivity; Electroencephalogram; Traumatic Brain Injury; CerebroVascular Accident

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evolution of performance at GAS (Goal Attainment scaling) in short term

  Just after the cognitive training phase (TF)

• Reaction time when performing TEA battery: Test of Everyday Attention

  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

  Before the cognitive training phase (T0), just after the cognitive training phase (TF) and the month following the cognitive training phase (TF+1)

Study Arms (3)

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

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

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

Behavioral: Cognitive training

Interventions

Cognitive training BEHAVIORAL

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

Arm 1 (early phase B); Arm 2 (mid phase B); Arm 3 (late phase B)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• ISAE-SUPAERO: collaborator

Study Sites (1)

Universty hospital of Toulouse (Rangueil)

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stroke

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Xavier De Boissezon, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: N of 1 Trials with multiple Baseline with 3 phases

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: February 4, 2020
• Primary Completion: December 13, 2022
• Study Completion: December 13, 2022
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

FR (1)