Neurorehabilitation After Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study
NCT ID: NCT02698449
Last Updated: 2023-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2017-01-24
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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cognitive rehabilitation + transcranial stimulation
specific cognitive rehabilitation combined to transcranial direct current stimulation
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
Specific cognitive rehabilitation will be personalized regarding the cognitive complaint and will include a training part and an ecological part.
functional 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.
cognitive rehabilitation + stimulation sham
specific cognitive rehabilitation combined to transcranial direct current stimulation sham
Specific cognitive rehabilitation
Specific cognitive rehabilitation will be personalized regarding the cognitive complaint and will include a training part and an ecological part.
transcranial direct current stimulation sham
the same operation that transcranial direct current stimulating but it is a sham surgery
functional 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.
placebo rehab + transcranial stimulation
nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation
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.
Nonspecific cognitive rehabilitation
Nonspecific cognitive rehabilitation will be focused on representation of body in space.
functional 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.
placebo rehab + stimulation sham
nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation sham
Nonspecific cognitive rehabilitation
Nonspecific cognitive rehabilitation will be focused on representation of body in space.
transcranial direct current stimulation sham
the same operation that transcranial direct current stimulating but it is a sham surgery
functional 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.
Interventions
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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
Specific cognitive rehabilitation will be personalized regarding the cognitive complaint and will include a training part and an ecological part.
Nonspecific cognitive rehabilitation
Nonspecific cognitive rehabilitation will be focused on representation of body in space.
transcranial direct current stimulation sham
the same operation that transcranial direct current stimulating but it is a sham surgery
functional 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* No attentional impairment (PASAT ≥ centile10)
* Severe depression
* Neurological disease
* Major cognitive impairment (aphasia, neglect)
* Drugs addiction
* Pregnant women and women having no contraceptive treatment
18 Years
60 Years
ALL
No
Sponsors
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Fondation de l'Avenir
OTHER
University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Jérémie Pariente, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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CHU Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC31/14/7328
Identifier Type: -
Identifier Source: org_study_id
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