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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03513133
Recruitment Status : Unknown
Verified February 2018 by Centre d'Investigation Clinique et Technologique 805.
Recruitment status was:  Recruiting
First Posted : May 1, 2018
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805

Study Description
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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)

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Cognitive Impairment Behavioral: working memory training Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: a group of 10 patients with severe TBI will receive 3-month rehabilitation of working memory and will be compared to a group of 10 healthy controls
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rehabilitation of Working Memory After Traumatic Brain Injury: Pilot Study of Brain Plasticity in Multimodal Advanced MRI
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. working memory testing [ Time Frame: change from baseline to 3 months ]
    neuropsychological assessment of working memory

  2. neuro-imaging changes [ Time Frame: change from baseline to 3 months ]
    multimodal 3T MRI


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513133


Contacts
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Contact: Philippe AZOUVI, MD-PhD 0033 147107074 philippe.azouvi@aphp.fr
Contact: Erica VLACHOS, CRA 0033 147104472 erica.vlachos@aphp.fr

Locations
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France
APHP Hôpital Raymond Poincaré Recruiting
Garches, Ile De France, France, 92380
Contact: Philippe AZOUVI, MD-PhD    0033 147107074    philippe.azouvi@aphp.fr   
Contact: Erica VLACHOS, CRA    0033 147104472    erica.vlachos@aphp.fr   
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
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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
More Information
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Publications:

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Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT03513133    
Other Study ID Numbers: 2016-A00678-43
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre d'Investigation Clinique et Technologique 805:
working memory
cognitive rehabilitation
functional neuroimaging
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System