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Rehabilitation of Working Memory and Brain Plasticity After Traumatic Brain Injury: Plastim-MDTC

C

Centre d'Investigation Clinique et Technologique 805

Status

Unknown

Conditions

Traumatic Brain Injury
Cognitive Impairment

Treatments

Behavioral: working memory training

Study type

Interventional

Funder types

Other

Identifiers

NCT03513133
2016-A00678-43

Details and patient eligibility

About

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)

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

working memory training
Experimental group
Description:
Patients with severe TBI will receive a hierarchical training of working memory according to a previously described methodology. They will receive 3 sessions per week during three months (each session=1 h approximately)
Treatment:
Behavioral: working memory training

Trial contacts and locations

1

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Central trial contact

Philippe AZOUVI, MD-PhD; Erica VLACHOS, CRA

Data sourced from clinicaltrials.gov

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