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

Primary Purpose

Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transcranial direct current stimulation
Specific cognitive rehabilitation
Nonspecific cognitive rehabilitation
transcranial direct current stimulation sham
functional Magnetic Resonance Imaging n-back task
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

cognitive rehabilitation + transcranial stimulation

cognitive rehabilitation + stimulation sham

placebo rehab + transcranial stimulation

placebo rehab + stimulation sham

Arm Description

specific cognitive rehabilitation combined to transcranial direct current stimulation

specific cognitive rehabilitation combined to transcranial direct current stimulation sham

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Intergroup differences in resting activation maps.
Intergroup differences in diffusion measures
Intergroup differences in neuropsychological score
Correlation between activation extend and attentional outcomes
Intergroup differences in polymorphisms

Full Information

First Posted
February 18, 2016
Last Updated
March 29, 2023
Sponsor
University Hospital, Toulouse
Collaborators
Fondation de l'Avenir
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1. Study Identification

Unique Protocol Identification Number
NCT02698449
Brief Title
Neurorehabilitation After Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study
Acronym
RemCog-TC
Official Title
Cognitive Rehabilitation Combined to Transcranial Direct Current Stimulation Following Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2017 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Fondation de l'Avenir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cognitive rehabilitation + transcranial stimulation
Arm Type
Experimental
Arm Description
specific cognitive rehabilitation combined to transcranial direct current stimulation
Arm Title
cognitive rehabilitation + stimulation sham
Arm Type
Experimental
Arm Description
specific cognitive rehabilitation combined to transcranial direct current stimulation sham
Arm Title
placebo rehab + transcranial stimulation
Arm Type
Experimental
Arm Description
nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation
Arm Title
placebo rehab + stimulation sham
Arm Type
Experimental
Arm Description
nonspecific cognitive rehabilitation (placebo rehab) combined to transcranial direct current stimulation sham
Intervention Type
Procedure
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Specific cognitive rehabilitation
Intervention Description
Specific cognitive rehabilitation will be personalized regarding the cognitive complaint and will include a training part and an ecological part.
Intervention Type
Procedure
Intervention Name(s)
Nonspecific cognitive rehabilitation
Intervention Description
Nonspecific cognitive rehabilitation will be focused on representation of body in space.
Intervention Type
Procedure
Intervention Name(s)
transcranial direct current stimulation sham
Intervention Description
the same operation that transcranial direct current stimulating but it is a sham surgery
Intervention Type
Radiation
Intervention Name(s)
functional Magnetic Resonance Imaging n-back task
Intervention Description
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.
Primary Outcome Measure Information:
Title
intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Intergroup differences in resting activation maps.
Time Frame
12 weeks
Title
Intergroup differences in diffusion measures
Time Frame
12 weeks
Title
Intergroup differences in neuropsychological score
Time Frame
12 weeks
Title
Correlation between activation extend and attentional outcomes
Time Frame
12 weeks
Title
Intergroup differences in polymorphisms
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jérémie Pariente, PhD
Phone
(0)5.61.77.95.02
Ext
33
Email
pariente.j@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie Rigal, MD
Phone
(0)5.61.77.57.25
Ext
33
Email
rigal.e@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérémie Pariente, PhD
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérémie Pariente, PhD
Phone
0(5).61.77.95.02
Ext
33
Email
pariente.j@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Emilie Rigal, MD
Phone
(0)5.61.77.57.25
Ext
33
Email
rigal.e@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Neurorehabilitation After Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study

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