Rehabilitation of Working Memory and Brain Plasticity After Traumatic Brain Injury: Plastim-MDTC

Study Overview
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Brief Summary
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The aim of this study is to assess the brain correlates, as assessed with multimodal MRI, of working memory training in patients with severe traumatic brain injury (TBI)

Detailed Description
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This is a pilot feasibility study. Patients with subacute/chronic (> 6 months) severe TBI will be included if they suffer from a deficit in working memory. They will receive a specific hierarchical training of working memory (3 sessions per week during three months), according to a previously described methodology. A multimodal MRI will be performed at neuroSpin center (CEA, Orsay, France) before and after cognitive training, including: structural imaging (T1, FLAIR and diffusion tensor imaging, DTI); functional connectivity at rest; and functional activation during a working memory task (n-back). Behavioral and imaging changes after training will be analysed individually and compared to a group of healthy controls matched for age, gender and education.

Official Title
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Rehabilitation of Working Memory After Traumatic Brain Injury: Pilot Study of Brain Plasticity in Multimodal Advanced MRI

Conditions
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Traumatic Brain Injury, Cognitive Impairment

Intervention / Treatment
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* Behavioral: working memory training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: moderate to severe traumatic brain injury 6 months or more after the injury working memory deficit on cognitive testing Exclusion Criteria: previous neurological or psychiatric condition severe behavioral troubles contra-indication to MRI pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: a group of 10 patients with severe TBI will receive 3-month rehabilitation of working memory and will be compared to a group of 10 healthy controls
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: working memory training<br>Patients with severe TBI will receive a hierarchical training of working memory according to a previously described methodology. They will receive 3 sessions per week during three months (each session=1 h approximately) | Behavioral: working memory training<br>* Hierarchical cognitive training of the different components of working memory according to Baddeley model; 15 tasks are used addressing: the phonological loop (8 tasks), the visuospatial sketchpad (4 tasks) and the central executive 3 tasks). Task are given in a hierarchical order, according to each individual patient's deficits and improvement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| working memory questionnaire | It is a self-assessment questionnaire comprising 30 questions scored on a five-point Likert scale, ranging from 0 (no problem at all) to 4 (very severe problem in everyday life). The total score will be used. | change from baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| working memory testing | neuropsychological assessment of working memory | change from baseline to 3 months | 
| neuro-imaging changes | multimodal 3T MRI | change from baseline to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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working memory, cognitive rehabilitation, functional neuroimaging