NCT03513133

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

May 3, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

February 19, 2018

Last Update Submit

May 2, 2018

Conditions

Traumatic Brain InjuryCognitive Impairment

Keywords

working memorycognitive rehabilitationfunctional neuroimaging

Outcome Measures

Primary Outcomes (1)

  • 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.

    change from baseline to 3 months

Secondary Outcomes (2)

  • working memory testing

    change from baseline to 3 months

  • neuro-imaging changes

    change from baseline to 3 months

Study Arms (1)

working memory training

EXPERIMENTAL

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

Interventions

working memory trainingBEHAVIORAL

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.

working memory training

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • moderate to severe traumatic brain injury
  • months or more after the injury
  • working memory deficit on cognitive testing

You may not qualify if:

  • previous neurological or psychiatric condition
  • severe behavioral troubles
  • contra-indication to MRI
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APHP Hôpital Raymond Poincaré

Garches, Île-de-France Region, 92380, France

RECRUITING

Related Publications (4)

  • 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.

    PMID: 16286329BACKGROUND

  • 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.

    PMID: 22537095BACKGROUND

  • 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.

    PMID: 19484632BACKGROUND

  • 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.

    PMID: 24552571BACKGROUND

MeSH Terms

Conditions

Brain Injuries, TraumaticCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Philippe AZOUVI, MD-PhD

    APHP Hôpital Raymond Poincaré

    STUDY CHAIR

  • Lucie HERTZ PANNIER, MD

    Neurospin- CEA

    PRINCIPAL INVESTIGATOR

  • Eric BRUNET, MD

    Hôpital André Mignot

    PRINCIPAL INVESTIGATOR

  • Claire Vallat-Azouvi, PhD

    University of Paris 8

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe AZOUVI, MD-PhD

CONTACT

0033 147107074philippe.azouvi@aphp.fr

Erica VLACHOS, CRA

CONTACT

0033 147104472erica.vlachos@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2018

First Posted

May 1, 2018

Study Start

July 1, 2017

Primary Completion

July 1, 2019

Study Completion

December 31, 2019

Last Updated

May 3, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)