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Clinical Trials/NCT02698449
NCT02698449
Recruiting
N/A

Cognitive Rehabilitation Combined to Transcranial Direct Current Stimulation Following Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study

University Hospital, Toulouse1 site in 1 country80 target enrollmentJanuary 24, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
University Hospital, Toulouse
Enrollment
80
Locations
1
Primary Endpoint
intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task).
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 24, 2017
End Date
December 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task).

Time Frame: 12 weeks

Secondary Outcomes

  • Intergroup differences in neuropsychological score(12 weeks)
  • Intergroup differences in resting activation maps.(12 weeks)
  • Correlation between activation extend and attentional outcomes(12 weeks)
  • Intergroup differences in diffusion measures(12 weeks)
  • Intergroup differences in polymorphisms(12 weeks)

Study Sites (1)

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