Clinical trial NCT02698449: Neurorehabilitation After Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study
Official title: Cognitive Rehabilitation Combined to Transcranial Direct Current Stimulation Following Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Fondation de l'Avenir
First posted: 2016-03-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task).
timeFrame: 12 weeks
Secondary outcomes:
measure: Intergroup differences in resting activation maps.
timeFrame: 12 weeks
measure: Intergroup differences in diffusion measures
timeFrame: 12 weeks
measure: Intergroup differences in neuropsychological score
timeFrame: 12 weeks
measure: Correlation between activation extend and attentional outcomes
timeFrame: 12 weeks
measure: Intergroup differences in polymorphisms
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse
name: Jérémie Pariente, PhD
role: PRINCIPAL_INVESTIGATOR
References: