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| Name | Class |
|---|---|
| Fondation de l'Avenir | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cognitive rehabilitation + transcranial stimulation | Experimental | specific cognitive rehabilitation combined to transcranial direct current stimulation |
|
| cognitive rehabilitation + stimulation sham | Experimental | specific cognitive rehabilitation combined to transcranial direct current stimulation sham |
|
| placebo rehab + transcranial stimulation | Experimental | nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation |
|
| placebo rehab + stimulation sham | Experimental | nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation sham |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Intergroup differences in resting activation maps. | 12 weeks | |
| Intergroup differences in diffusion measures | 12 weeks | |
| Intergroup differences in neuropsychological score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jérémie Pariente, PhD | Contact | (0)5.61.77.95.02 | 33 | pariente.j@chu-toulouse.fr |
| Emilie Rigal, MD | Contact | (0)5.61.77.57.25 | 33 | rigal.e@chu-toulouse.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jérémie Pariente, PhD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Toulouse | Recruiting | Toulouse | 31059 | France |
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| Specific cognitive rehabilitation | Procedure | Specific cognitive rehabilitation will be personalized regarding the cognitive complaint and will include a training part and an ecological part. |
|
| Nonspecific cognitive rehabilitation | Procedure | Nonspecific cognitive rehabilitation will be focused on representation of body in space. |
|
| transcranial direct current stimulation sham | Procedure | the same operation that transcranial direct current stimulating but it is a sham surgery |
|
| functional Magnetic Resonance Imaging n-back task | Radiation | 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. |
|
| 12 weeks |
| Correlation between activation extend and attentional outcomes | 12 weeks |
| Intergroup differences in polymorphisms | 12 weeks |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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