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

Not Applicable

• Conditions: Cognitive Impairment; Traumatic Brain Injury
• Interventions: Behavioral: working memory training

• Registration Number: NCT03513133
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

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.

Study Timeline

• Study Start: 2017-07-01
• Status Verified: 2018-02
• Study First Submitted: 2018-02-19
• Study First Submitted QC: 2018-04-30
• Study First Posted: 2018-05-01
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03
• Primary Completion: 2019-07-01
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
working memory training	working memory training	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)

Primary Outcome Measures

Name	Time	Method
working memory questionnaire	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 Outcome Measures

Name	Time	Method
working memory testing	change from baseline to 3 months	neuropsychological assessment of working memory
neuro-imaging changes	change from baseline to 3 months	multimodal 3T MRI

Trial Locations

Locations (1)

APHP Hôpital Raymond Poincaré; 🇫🇷 Garches, Ile De France, France