Neurorehabilitation After Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study (RemCog-TC)
Cognitive Rehabilitation Combined to Transcranial Direct Current Stimulation Following Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study
The current study aims to better understand cerebral plasticity mechanisms to optimize non-pharmacological rehabilitation approaches for patients with traumatic brain injury.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Toulouse, France, 31059
- CHU Toulouse
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: cognitive rehabilitation + transcranial stimulation
specific cognitive rehabilitation combined to transcranial 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. Specific cognitive rehabilitation will be personalized regarding the cognitive complaint and will include a training part and an ecological part. 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. |
|
Experimental: cognitive rehabilitation + stimulation sham
specific cognitive rehabilitation combined to transcranial direct current stimulation sham |
Specific cognitive rehabilitation will be personalized regarding the cognitive complaint and will include a training part and an ecological part. 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. the same operation that transcranial direct current stimulating but it is a sham surgery |
|
Experimental: placebo rehab + transcranial stimulation
nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation |
|
|
Experimental: placebo rehab + stimulation sham
nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation sham |
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. the same operation that transcranial direct current stimulating but it is a sham surgery Nonspecific cognitive rehabilitation will be focused on representation of body in space. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task).
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Intergroup differences in resting activation maps.
Time Frame: 12 weeks
|
12 weeks
|
|
Intergroup differences in diffusion measures
Time Frame: 12 weeks
|
12 weeks
|
|
Intergroup differences in neuropsychological score
Time Frame: 12 weeks
|
12 weeks
|
|
Correlation between activation extend and attentional outcomes
Time Frame: 12 weeks
|
12 weeks
|
|
Intergroup differences in polymorphisms
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jérémie Pariente, PhD, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Craniocerebral Trauma
- Trauma, Nervous System
- Brain Injuries
- Brain Injuries, Traumatic
- Therapeutics
- Behavioral Disciplines and Activities
- Electric Stimulation Therapy
- Convulsive Therapy
- Psychiatric Somatic Therapies
- Electroshock
- Psychological Techniques
- Transcranial Direct Current Stimulation
Other Study ID Numbers
- RC31/14/7328
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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