Neurorehabilitation After Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study

Not Applicable

Recruiting

• Conditions: Traumatic Brain Injury
• Interventions: Procedure: Nonspecific cognitive rehabilitation; Procedure: transcranial direct current stimulation; Procedure: Specific cognitive rehabilitation; Procedure: transcranial direct current stimulation sham; Radiation: functional Magnetic Resonance Imaging n-back task

• Registration Number: NCT02698449
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-02-26
• Study First Posted: 2016-03-03
• Study Start: 2017-01-24
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-30
• Primary Completion: 2023-07
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo rehab + stimulation sham	functional Magnetic Resonance Imaging n-back task	nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation sham
cognitive rehabilitation + transcranial stimulation	Specific cognitive rehabilitation	specific cognitive rehabilitation combined to transcranial direct current stimulation
placebo rehab + stimulation sham	Nonspecific cognitive rehabilitation	nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation sham
placebo rehab + stimulation sham	transcranial direct current stimulation sham	nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation sham
cognitive rehabilitation + transcranial stimulation	transcranial direct current stimulation	specific cognitive rehabilitation combined to transcranial direct current stimulation
cognitive rehabilitation + transcranial stimulation	functional Magnetic Resonance Imaging n-back task	specific cognitive rehabilitation combined to transcranial direct current stimulation
placebo rehab + transcranial stimulation	functional Magnetic Resonance Imaging n-back task	nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation
cognitive rehabilitation + stimulation sham	Specific cognitive rehabilitation	specific cognitive rehabilitation combined to transcranial direct current stimulation sham
placebo rehab + transcranial stimulation	transcranial direct current stimulation	nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation
placebo rehab + transcranial stimulation	Nonspecific cognitive rehabilitation	nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation
cognitive rehabilitation + stimulation sham	transcranial direct current stimulation sham	specific cognitive rehabilitation combined to transcranial direct current stimulation sham
cognitive rehabilitation + stimulation sham	functional Magnetic Resonance Imaging n-back task	specific cognitive rehabilitation combined to transcranial direct current stimulation sham

Primary Outcome Measures

Name	Time	Method
intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task).	12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Toulouse; 🇫🇷 Toulouse, France