Neurorehabilitation After Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study (RemCog-TC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02698449 |
Recruitment Status
:
Not yet recruiting
First Posted
: March 3, 2016
Last Update Posted
: March 10, 2016
|
Sponsor:
University Hospital, Toulouse
Collaborator:
Fondation de l'Avenir
Information provided by (Responsible Party):
University Hospital, Toulouse
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | February 18, 2016 | ||||||||
First Posted Date ICMJE | March 3, 2016 | ||||||||
Last Update Posted Date | March 10, 2016 | ||||||||
Study Start Date ICMJE | September 2016 | ||||||||
Estimated Primary Completion Date | March 2019 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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 |
|
||||||||
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) |
||||||||
Condition ICMJE | Traumatic Brain Injury | ||||||||
Intervention ICMJE |
|
||||||||
Study Arms |
|
||||||||
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 | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
|
||||||||
Sex/Gender |
|
||||||||
Ages | 18 Years to 60 Years (Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
|
||||||||
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 | Not Provided | ||||||||
IPD Sharing Statement |
|
||||||||
Responsible Party | University Hospital, Toulouse | ||||||||
Study Sponsor ICMJE | University Hospital, Toulouse | ||||||||
Collaborators ICMJE | Fondation de l'Avenir | ||||||||
Investigators ICMJE |
|
||||||||
PRS Account | University Hospital, Toulouse | ||||||||
Verification Date | March 2016 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |