Neurorehabilitation After Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study

Study Overview
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Brief Summary
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The current study aims to better understand cerebral plasticity mechanisms to optimize non-pharmacological rehabilitation approaches for patients with traumatic brain injury.

Detailed Description
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Cognitive impairment following moderate to severe traumatic brain injury are usual. To date, cognitive rehabilitation effects on cerebral plasticity and quality of life remain unproven essentially because of methodological biases. Transcranial Direct Current Stimulation is an innovative technique of noninvasive brain stimulation that showed efficacy in literature. The current study want to better understand cerebral plasticity mechanisms to optimize non-pharmacological rehabilitation approaches for patients with traumatic brain injury. The aim in the present study is to assess the effect of rehabilitation combined with Transcranial Direct Current Stimulation provided to traumatic brain injury patients with cognitive impairment on cerebral plasticity using functional magnetic resonance imaging. Effects of rehabilitation and Transcranial Direct Current Stimulation will be observed on functional magnetic resonance imaging activation maps acquired. Relationship between attentional outcomes measured in the neuropsychological assessment and activation extend will be explored.

Official Title
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Cognitive Rehabilitation Combined to Transcranial Direct Current Stimulation Following Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Procedure: transcranial direct current stimulation
* Procedure: Specific cognitive rehabilitation
* Procedure: Nonspecific cognitive rehabilitation
* Procedure: transcranial direct current stimulation sham
* Radiation: functional Magnetic Resonance Imaging n-back task


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe traumatic brain injury more than 3 months since the onset Attentional disorders (PASAT test (score ≤ centile 10) and/or CANTAB test (≤ -2 standard deviation) Women having contraceptive treatment (for the magnetic resonance imaging exam) Exclusion Criteria: inability to undergo magnetic resonance imaging scan No attentional impairment (PASAT ≥ centile10) Severe depression Neurological disease Major cognitive impairment (aphasia, neglect) Drugs addiction Pregnant women and women having no contraceptive treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cognitive rehabilitation + transcranial stimulation<br>specific cognitive rehabilitation combined to transcranial direct current stimulation | Procedure: transcranial direct current stimulation<br>* intensity provided will be 2 milliampere during 20 minutes using 2 electrodes (7x5cm). Anode electrode will be located on the right prefrontal dorsolateral area; cathode electrode will be located on the left supraorbital area.<br>Procedure: Specific cognitive rehabilitation<br>* Specific cognitive rehabilitation will be personalized regarding the cognitive complaint and will include a training part and an ecological part.<br>Radiation: functional Magnetic Resonance Imaging n-back task<br>* the n-back cognitive task was developed : 3 runs will be provided (0-back, 1-back and 2-back), each will be composed of 8 activation blocks and 8 resting blocks alternatively presented.<br>|
| Experimental: cognitive rehabilitation + stimulation sham<br>specific cognitive rehabilitation combined to transcranial direct current stimulation sham | Procedure: Specific cognitive rehabilitation<br>* Specific cognitive rehabilitation will be personalized regarding the cognitive complaint and will include a training part and an ecological part.<br>Procedure: transcranial direct current stimulation sham<br>* the same operation that transcranial direct current stimulating but it is a sham surgery<br>Radiation: functional Magnetic Resonance Imaging n-back task<br>* the n-back cognitive task was developed : 3 runs will be provided (0-back, 1-back and 2-back), each will be composed of 8 activation blocks and 8 resting blocks alternatively presented.<br>|
| Experimental: placebo rehab + transcranial stimulation<br>nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation | Procedure: transcranial direct current stimulation<br>* intensity provided will be 2 milliampere during 20 minutes using 2 electrodes (7x5cm). Anode electrode will be located on the right prefrontal dorsolateral area; cathode electrode will be located on the left supraorbital area.<br>Procedure: Nonspecific cognitive rehabilitation<br>* Nonspecific cognitive rehabilitation will be focused on representation of body in space.<br>Radiation: functional Magnetic Resonance Imaging n-back task<br>* the n-back cognitive task was developed : 3 runs will be provided (0-back, 1-back and 2-back), each will be composed of 8 activation blocks and 8 resting blocks alternatively presented.<br>|
| Experimental: placebo rehab + stimulation sham<br>nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation sham | Procedure: Nonspecific cognitive rehabilitation<br>* Nonspecific cognitive rehabilitation will be focused on representation of body in space.<br>Procedure: transcranial direct current stimulation sham<br>* the same operation that transcranial direct current stimulating but it is a sham surgery<br>Radiation: functional Magnetic Resonance Imaging n-back task<br>* the n-back cognitive task was developed : 3 runs will be provided (0-back, 1-back and 2-back), each will be composed of 8 activation blocks and 8 resting blocks alternatively presented.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task). |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intergroup differences in resting activation maps. |  | 12 weeks | 
| Intergroup differences in diffusion measures |  | 12 weeks | 
| Intergroup differences in neuropsychological score |  | 12 weeks | 
| Correlation between activation extend and attentional outcomes |  | 12 weeks | 
| Intergroup differences in polymorphisms |  | 12 weeks |