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

Primary Purpose

Traumatic Brain Injury, Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
working memory training
Sponsored by
Centre d'Investigation Clinique et Technologique 805
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring working memory, cognitive rehabilitation, functional neuroimaging

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

  • APHP Hôpital Raymond PoincaréRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

working memory training

Arm 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)

Outcomes

Primary Outcome Measures

working memory questionnaire
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

working memory testing
neuropsychological assessment of working memory
neuro-imaging changes
multimodal 3T MRI

Full Information

First Posted
February 19, 2018
Last Updated
May 2, 2018
Sponsor
Centre d'Investigation Clinique et Technologique 805
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1. Study Identification

Unique Protocol Identification Number
NCT03513133
Brief Title
Rehabilitation of Working Memory and Brain Plasticity After Traumatic Brain Injury: Plastim-MDTC
Acronym
Plastim-MDTC
Official Title
Rehabilitation of Working Memory After Traumatic Brain Injury: Pilot Study of Brain Plasticity in Multimodal Advanced MRI
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 1, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Cognitive Impairment
Keywords
working memory, cognitive rehabilitation, functional neuroimaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
working memory training
Arm Type
Experimental
Arm 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)
Intervention Type
Behavioral
Intervention Name(s)
working memory training
Intervention Description
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.
Primary Outcome Measure Information:
Title
working memory questionnaire
Description
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.
Time Frame
change from baseline to 3 months
Secondary Outcome Measure Information:
Title
working memory testing
Description
neuropsychological assessment of working memory
Time Frame
change from baseline to 3 months
Title
neuro-imaging changes
Description
multimodal 3T MRI
Time Frame
change from baseline to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe AZOUVI, MD-PhD
Phone
0033 147107074
Email
philippe.azouvi@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Erica VLACHOS, CRA
Phone
0033 147104472
Email
erica.vlachos@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe AZOUVI, MD-PhD
Organizational Affiliation
APHP Hôpital Raymond Poincaré
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lucie HERTZ PANNIER, MD
Organizational Affiliation
Neurospin- CEA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric BRUNET, MD
Organizational Affiliation
Hôpital André Mignot
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claire Vallat-Azouvi, PhD
Organizational Affiliation
University of Paris 8
Official's Role
Principal Investigator
Facility Information:
Facility Name
APHP Hôpital Raymond Poincaré
City
Garches
State/Province
Ile De France
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe AZOUVI, MD-PhD
Phone
0033 147107074
Email
philippe.azouvi@aphp.fr
First Name & Middle Initial & Last Name & Degree
Erica VLACHOS, CRA
Phone
0033 147104472
Email
erica.vlachos@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16286329
Citation
Vallat C, Azouvi P, Hardisson H, Meffert R, Tessier C, Pradat-Diehl P. Rehabilitation of verbal working memory after left hemisphere stroke. Brain Inj. 2005 Dec;19(13):1157-64. doi: 10.1080/02699050500110595.
Results Reference
background
PubMed Identifier
22537095
Citation
Vallat-Azouvi C, Pradat-Diehl P, Azouvi P. The Working Memory Questionnaire: a scale to assess everyday life problems related to deficits of working memory in brain injured patients. Neuropsychol Rehabil. 2012;22(4):634-49. doi: 10.1080/09602011.2012.681110. Epub 2012 Apr 27.
Results Reference
background
PubMed Identifier
19484632
Citation
Vallat-Azouvi C, Pradat-Diehl P, Azouvi P. Rehabilitation of the central executive of working memory after severe traumatic brain injury: two single-case studies. Brain Inj. 2009 Jun;23(6):585-94. doi: 10.1080/02699050902970711.
Results Reference
background
PubMed Identifier
24552571
Citation
Vallat-Azouvi C, Pradat-Diehl P, Azouvi P. Modularity in rehabilitation of working memory: a single-case study. Neuropsychol Rehabil. 2014;24(2):220-37. doi: 10.1080/09602011.2014.881294. Epub 2014 Feb 19.
Results Reference
background

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

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