Neurorehabilitation After Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study

Traumatic Brain Injury Clinical Trial

— RemCog-TC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02698449
• Other study ID #: RC31/14/7328
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2017
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: University Hospital, Toulouse
• Contact: Jérémie Pariente, PhD
• Phone: (0)5.61.77.95.02
• Email: pariente.j[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.
• Specific cognitive rehabilitation
Specific cognitive rehabilitation will be personalized regarding the cognitive complaint and will include a training part and an ecological part.
• Nonspecific cognitive rehabilitation
Nonspecific cognitive rehabilitation will be focused on representation of body in space.
• 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.

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Fondation de l'Avenir

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task).		12 weeks
Secondary	Intergroup differences in resting activation maps.		12 weeks
Secondary	Intergroup differences in diffusion measures		12 weeks
Secondary	Intergroup differences in neuropsychological score		12 weeks
Secondary	Correlation between activation extend and attentional outcomes		12 weeks
Secondary	Intergroup differences in polymorphisms		12 weeks