Neurorehabilitation After Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study (RemCog-TC)

Tracking Information
First Submitted Date ICMJE	February 18, 2016
First Posted Date ICMJE	March 3, 2016
Last Update Posted Date	November 8, 2018
Actual Study Start Date ICMJE	January 24, 2017
Estimated Primary Completion Date	March 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 26, 2016)	intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task). [ Time Frame: 12 weeks ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT02698449 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 26, 2016)	Intergroup differences in resting activation maps. [ Time Frame: 12 weeks ]; Intergroup differences in diffusion measures [ Time Frame: 12 weeks ]; Intergroup differences in neuropsychological score [ Time Frame: 12 weeks ]; Correlation between activation extend and attentional outcomes [ Time Frame: 12 weeks ]; Intergroup differences in polymorphisms [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Neurorehabilitation After Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study
Official Title ICMJE	Cognitive Rehabilitation Combined to Transcranial Direct Current Stimulation Following Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
Condition ICMJE	Traumatic Brain Injury
Intervention ICMJE	Procedure: 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.; Procedure: Specific cognitive rehabilitation Specific cognitive rehabilitation will be personalized regarding the cognitive complaint and will include a training part and an ecological part.; Procedure: Nonspecific cognitive rehabilitation Nonspecific cognitive rehabilitation will be focused on representation of body in space.; Procedure: transcranial direct current stimulation sham the same operation that transcranial direct current stimulating but it is a sham surgery; Radiation: 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.
Study Arms	Experimental: cognitive rehabilitation + transcranial stimulation specific cognitive rehabilitation combined to transcranial direct current stimulation Interventions: Procedure: transcranial direct current stimulation Procedure: Specific cognitive rehabilitation Radiation: functional Magnetic Resonance Imaging n-back task; Experimental: cognitive rehabilitation + stimulation sham specific cognitive rehabilitation combined to transcranial direct current stimulation sham Interventions: Procedure: Specific cognitive rehabilitation Procedure: transcranial direct current stimulation sham Radiation: functional Magnetic Resonance Imaging n-back task; Experimental: placebo rehab + transcranial stimulation nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation Interventions: Procedure: transcranial direct current stimulation Procedure: Nonspecific cognitive rehabilitation Radiation: functional Magnetic Resonance Imaging n-back task; Experimental: placebo rehab + stimulation sham nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation sham Interventions: Procedure: Nonspecific cognitive rehabilitation Procedure: transcranial direct current stimulation sham Radiation: functional Magnetic Resonance Imaging n-back task
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: February 26, 2016)	80
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	March 2019
Estimated Primary Completion Date	March 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 60 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Jérémie Pariente, PhD (0)5.61.77.95.02 ext 33 pariente.j@chu-toulouse.fr Contact: Emilie Rigal, MD (0)5.61.77.57.25 ext 33 rigal.e@chu-toulouse.fr
Listed Location Countries ICMJE	France
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT02698449
Other Study ID Numbers ICMJE	14 7328 03
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	University Hospital, Toulouse
Study Sponsor ICMJE	University Hospital, Toulouse
Collaborators ICMJE	Fondation de l'Avenir
Investigators ICMJE	Principal Investigator: Jérémie Pariente, PhD CHU TOULOUSE
PRS Account	University Hospital, Toulouse
Verification Date	November 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP