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

May 2, 2018 updated by: Centre d'Investigation Clinique et Technologique 805

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

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Ile De France
      • Garches, Ile De France, France, 92380
        • Recruiting
        • APHP Hôpital Raymond Poincaré
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Behavioral: working memory training
Hierarchical cognitive training of the different components of working memory according to Baddeley model; 15 tasks are used addressing: the phonological loop (8 tasks), the visuospatial sketchpad (4 tasks) and the central executive 3 tasks). Task are given in a hierarchical order, according to each individual patient's deficits and improvement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
change from baseline to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
working memory testing
Time Frame: change from baseline to 3 months
neuropsychological assessment of working memory
change from baseline to 3 months
neuro-imaging changes
Time Frame: change from baseline to 3 months
multimodal 3T MRI
change from baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre d'Investigation Clinique et Technologique 805

Investigators

  • Study Chair: Philippe AZOUVI, MD-PhD, APHP Hôpital Raymond Poincaré
  • Principal Investigator: Lucie HERTZ PANNIER, MD, Neurospin- CEA
  • Principal Investigator: Eric BRUNET, MD, Hôpital André Mignot
  • Principal Investigator: Claire Vallat-Azouvi, PhD, University of Paris 8

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

February 19, 2018

First Submitted That Met QC Criteria

April 30, 2018

First Posted (Actual)

May 1, 2018

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A00678-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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