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Clinical Trials/NCT04253522
NCT04253522
Terminated
N/A

Modulation and Assessment of Mental Flexibility in Dysexecutive Brain Patients

University Hospital, Toulouse1 site in 1 country16 target enrollmentFebruary 4, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dysexecutive Syndrome
Sponsor
University Hospital, Toulouse
Enrollment
16
Locations
1
Primary Endpoint
Evolution of performance at GAS (Goal Attainment scaling) in long term
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 4, 2020
End Date
December 13, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

  • 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))
  • Evolution of performance at GAS (Goal Attainment scaling) in short term(Just after the cognitive training phase (TF))
  • 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 Sites (1)

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