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

Toulouse University Hospital

Status: Enrolling

Conditions: Traumatic Brain Injury

Treatments: Radiation: functional Magnetic Resonance Imaging n-back task; Procedure: transcranial direct current stimulation sham; Procedure: Nonspecific cognitive rehabilitation; Procedure: transcranial direct current stimulation; Procedure: Specific cognitive rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT02698449

RC31/14/7328

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

cognitive rehabilitation + transcranial stimulation

Experimental group

Description:

specific cognitive rehabilitation combined to transcranial direct current stimulation

Treatment:

Procedure: Specific cognitive rehabilitation

Procedure: transcranial direct current stimulation

Radiation: functional Magnetic Resonance Imaging n-back task

cognitive rehabilitation + stimulation sham

Experimental group

Description:

specific cognitive rehabilitation combined to transcranial direct current stimulation sham

Treatment:

Procedure: Specific cognitive rehabilitation

Radiation: functional Magnetic Resonance Imaging n-back task

Procedure: transcranial direct current stimulation sham

placebo rehab + transcranial stimulation

Experimental group

Description:

nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation

Treatment:

Procedure: transcranial direct current stimulation

Procedure: Nonspecific cognitive rehabilitation

Radiation: functional Magnetic Resonance Imaging n-back task

placebo rehab + stimulation sham

Experimental group

Description:

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

Treatment:

Procedure: Nonspecific cognitive rehabilitation

Radiation: functional Magnetic Resonance Imaging n-back task

Procedure: transcranial direct current stimulation sham