Traumatic Brain Injury
Conditions
Brief summary
The current study aims to better understand cerebral plasticity mechanisms to optimize non-pharmacological rehabilitation approaches for patients with traumatic brain injury.
Detailed description
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.
Interventions
PROCEDUREtranscranial direct current stimulation
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.
PROCEDURESpecific cognitive rehabilitation
Specific cognitive rehabilitation will be personalized regarding the cognitive complaint and will include a training part and an ecological part.
PROCEDURENonspecific cognitive rehabilitation
Nonspecific cognitive rehabilitation will be focused on representation of body in space.
PROCEDUREtranscranial direct current stimulation sham
the same operation that transcranial direct current stimulating but it is a sham surgery
RADIATIONfunctional Magnetic Resonance Imaging n-back task
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.
Sponsors
Fondation de l'Avenir
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task). | 12 weeks |
Secondary
| Measure | 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 |
Countries
France
Contacts
Primary ContactJérémie Pariente, PhD
Backup ContactEmilie Rigal, MD
Outcome results
None listed