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

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ClinicalTrials.gov Identifier: NCT02698449
Recruitment Status : Recruiting
First Posted : March 3, 2016
Last Update Posted : November 8, 2018
Sponsor:
Collaborator:
Fondation de l'Avenir
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
The current study aims to better understand cerebral plasticity mechanisms to optimize non-pharmacological rehabilitation approaches for patients with traumatic brain injury.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Procedure: transcranial direct current stimulation Procedure: Specific cognitive rehabilitation Procedure: Nonspecific cognitive rehabilitation Procedure: transcranial direct current stimulation sham Radiation: functional Magnetic Resonance Imaging n-back task Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Cognitive Rehabilitation Combined to Transcranial Direct Current Stimulation Following Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study
Actual Study Start Date : January 24, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: cognitive rehabilitation + transcranial stimulation
specific cognitive rehabilitation combined to transcranial direct current stimulation
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.

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 + stimulation sham
specific cognitive rehabilitation combined to transcranial direct current stimulation sham
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: 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: placebo rehab + transcranial stimulation
nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation
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: Nonspecific cognitive rehabilitation
Nonspecific cognitive rehabilitation will be focused on representation of body in space.

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: placebo rehab + stimulation sham
nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation sham
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.




Primary Outcome Measures :
  1. intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task). [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Intergroup differences in resting activation maps. [ Time Frame: 12 weeks ]
  2. Intergroup differences in diffusion measures [ Time Frame: 12 weeks ]
  3. Intergroup differences in neuropsychological score [ Time Frame: 12 weeks ]
  4. Correlation between activation extend and attentional outcomes [ Time Frame: 12 weeks ]
  5. Intergroup differences in polymorphisms [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698449


Contacts
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

Locations
France
CHU Toulouse Recruiting
Toulouse, France, 31059
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   
Sponsors and Collaborators
University Hospital, Toulouse
Fondation de l'Avenir
Investigators
Principal Investigator: Jérémie Pariente, PhD CHU TOULOUSE

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02698449     History of Changes
Other Study ID Numbers: 14 7328 03
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System