ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
Collaborator:
Fondation de l'Avenir
Information provided by (Responsible Party):
University Hospital, Toulouse

February 18, 2016
March 3, 2016
March 10, 2016
September 2016
March 2019   (Final data collection date for primary outcome measure)
intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task). [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT02698449 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Neurorehabilitation After Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Traumatic Brain Injury
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
80
Same as current
March 2019
March 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
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
France
 
 
NCT02698449
14 7328 03
No
Not Provided
Plan to Share IPD: No
University Hospital, Toulouse
University Hospital, Toulouse
Fondation de l'Avenir
Principal Investigator: Jérémie Pariente, PhD CHU TOULOUSE
University Hospital, Toulouse
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP