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Clinical Trials/NCT03513133
NCT03513133
Unknown
Not Applicable

Rehabilitation of Working Memory After Traumatic Brain Injury: Pilot Study of Brain Plasticity in Multimodal Advanced MRI

Centre d'Investigation Clinique et Technologique 8051 site in 1 country20 target enrollmentJuly 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Centre d'Investigation Clinique et Technologique 805
Enrollment
20
Locations
1
Primary Endpoint
working memory questionnaire
Last Updated
8 years ago

Overview

Brief Summary

The aim of this study is to assess the brain correlates, as assessed with multimodal MRI, of working memory training in patients with severe traumatic brain injury (TBI)

Detailed Description

This is a pilot feasibility study. Patients with subacute/chronic (\> 6 months) severe TBI will be included if they suffer from a deficit in working memory. They will receive a specific hierarchical training of working memory (3 sessions per week during three months), according to a previously described methodology. A multimodal MRI will be performed at neuroSpin center (CEA, Orsay, France) before and after cognitive training, including: structural imaging (T1, FLAIR and diffusion tensor imaging, DTI); functional connectivity at rest; and functional activation during a working memory task (n-back). Behavioral and imaging changes after training will be analysed individually and compared to a group of healthy controls matched for age, gender and education.

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
December 31, 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Centre d'Investigation Clinique et Technologique 805
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • moderate to severe traumatic brain injury
  • 6 months or more after the injury
  • working memory deficit on cognitive testing

Exclusion Criteria

  • previous neurological or psychiatric condition
  • severe behavioral troubles
  • contra-indication to MRI
  • pregnancy

Outcomes

Primary Outcomes

working memory questionnaire

Time Frame: change from baseline to 3 months

It is a self-assessment questionnaire comprising 30 questions scored on a five-point Likert scale, ranging from 0 ("no problem at all") to 4 ("very severe problem in everyday life"). The total score will be used.

Secondary Outcomes

  • working memory testing(change from baseline to 3 months)
  • neuro-imaging changes(change from baseline to 3 months)

Study Sites (1)

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