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Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury (REHAB-MDT)

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ClinicalTrials.gov Identifier: NCT03874416
Recruitment Status : Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE February 4, 2019
First Posted Date  ICMJE March 14, 2019
Last Update Posted Date March 14, 2019
Estimated Study Start Date  ICMJE April 2019
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
Proportions of simultaneous responders [ Time Frame: 3 months after the first rehabilitation session ]
A patient will be considered as a responder if he improves simultaneously on the Working Memory Questionnaire (WMQ) and the Brown-Peterson Task. Proportions will be calculated of patients simultaneously improving on the Working Memory Questionnaire (WMQ) and the Brown-Peterson Task:
  • increase of at least 12 points on WMQ scale,
  • at least 13% score improvement on the verbal or visuo-spatial Brown-Peterson Task.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • Working Memory Questionnaire during rehabilitation program [ Time Frame: At baseline, 3 months, 6 months and 9 months ]
    The Working Memory Questionnaire (WMQ), an auto-questionnaire elaborated by the study team, will be used. The WMQ is a self-administered scale, addressing three dimensions of working memory: short-term storage, attention, and executive control. 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.
  • Cognitive task of working memory [ Time Frame: At baseline, 3 months, 6 months and 9 months ]
    Working memory span tasks
  • Cognitive task of working memory [ Time Frame: At baseline, 3 months, 6 months and 9 months ]
    Verbal and visuospatial working memory.
  • Cognitive task of working memory [ Time Frame: At baseline, 3 months, 6 months and 9 months ]
    n-back task
  • Cognitive task of working memory [ Time Frame: At baseline, 3 months, 6 months and 9 months ]
    Brown-Peterson Visual.
  • Cognitive task of working memory [ Time Frame: At baseline, 3 months, 6 months and 9 months ]
    reading span task.
  • Cognitive task of working memory [ Time Frame: At baseline, 3 months, 6 months and 9 months ]
    Working Memory Index (WISC-IV).
  • Cognitive task of working memory [ Time Frame: At baseline, 3 months, 6 months and 9 months ]
    divided attention task
  • Arithmetic resolution [ Time Frame: At baseline, 3 months and 6 months ]
    Non-specific tasks involving working memory: arithmetic resolution ability by WAIS index
  • Non-targeted cognitive measurements [ Time Frame: At baseline, 3 months and 6 months ]
    Executive functions will be assessed.
  • Non-targeted cognitive measurements [ Time Frame: At baseline, 3 months and 6 months ]
    Long-term memory will be assessed.
  • Non-targeted cognitive measurements [ Time Frame: At baseline, 3 months and 6 months ]
    The speed of treatment will be assessed.
  • Social functioning assessement [ Time Frame: At baseline, 3 months, 6 months and 9 months ]
    Assessed by Manual for Sydney Psychosocial Reintegration Scale (SPRS)
  • Quality of life assessment [ Time Frame: At baseline, 3 months, 6 months and 9 months ]
    Assessed by Qolibri scale
  • Quality of life assessment [ Time Frame: At baseline, 3 months, 6 months and 9 months ]
    Assessed by EQ5D-5
  • Acceptability [ Time Frame: At baseline, 3 months and 6 months ]
    Compliance of rehabilitation program: duration of training of speech-language pathologist and psychologist to the rehabilitation program.
  • Acceptability [ Time Frame: At baseline, 3 months and 6 months ]
    Compliance of rehabilitation program: duration of session.
  • Acceptability [ Time Frame: At baseline, 3 months and 6 months ]
    Compliance of rehabilitation program: patient's satisfaction of care (Client Satisfaction Questionnaire (CSQ-8)).
  • Acceptability [ Time Frame: At baseline, 3 months and 6 months ]
    Compliance of rehabilitation program: presence during rehabilitation session of working memory.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury
Official Title  ICMJE A Randomized Controlled Trial of Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury
Brief Summary

The study aims to demonstrate improvement of daily life functioning and improvement of cognitive tests in post traumatic brain injury (TBI) patients suffering from working memory deficit, by a 3-month specific cognitive rehabilitation program, in comparison with patients with usual non-specific rehabilitation of same duration.

As secondary objectives, the study aims to:

  • demonstrate improvement of specific neuropsychological tests of working memory;
  • demonstrate improvement of non-specific tasks involving working memory;
  • assess the evolution in not-targeted domains by the specific rehabilitation, which would give evidence of a global cognitive stimulation effect;
  • demonstrate improvement of social integration ability and quality of life;
  • demonstrate persistence of effects at 3 months and 6 months after the end of treatment;
  • demonstrate the acceptability, the tolerance and the feasibility of rehabilitation.
Detailed Description

Working memory is an essential cognitive function which allows to store briefly and treat simultaneous informations, but is often altered after a moderate to severe TBI. This alteration results in disabilities and social integration difficulties in the post TBI patients. The study team had developped a standardized and hierarchized rehabilitation program of working memory. Several experiments have shown the efficacy of the program which is now used in routine care by speech-language pathologists and neuropsychologists. However it is necessary to provide a robust demonstration of its efficacy in improving function in daily life.

This randomized multicenter study will be performed in 6 centers in the area of Île-de-France. 54 patients will be randomized 1:1 to receive either specific rehabilitation of working memory or non-specific rehabilitation. A 10-month follow-up is planned for patients of the two arms.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Single blind trial with 2 parallel arms:

Specific rehabilitation of working memory vs. non-specific rehabilitation

Masking: Single (Outcomes Assessor)
Masking Description:
Clinical assessment will be performed by an assessor blinded to group allocation.
Primary Purpose: Treatment
Condition  ICMJE Moderate to Severe Traumatic Brain Injury
Intervention  ICMJE
  • Other: Specific rehabilitation

    Experimental rehabilitation of working memory:

    3 sessions per week during 3 months, for a total 36 sessions.

  • Other: Non-specific rehabilitation
    Usual non-specific rehabilitation treatment for moderate to severe TBI in healthcare facilities: 2-3 sessions per week for 3 months.
Study Arms  ICMJE
  • Experimental: Specific rehabilitation of working memory
    Specific rehabilitation of working memory according to hierarchized rehabilitation.
    Intervention: Other: Specific rehabilitation
  • Active Comparator: Control group
    Non-specific rehabilitation of working memory, usual therapy.
    Intervention: Other: Non-specific rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 12, 2019)
54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2023
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged between 18 - 65 years;
  • Moderate to severe TBI (Glasgow score between 3 and 12 in the 24 first hours);
  • At least 6 months following TBI;
  • Complaint related to working memory in daily life (scale > 29 of questionnaire of complaint on working memory (WMQ), and established deficit of working memory by one of the following criteria:

    1. Index of working memory (IWM) of Wechsler Adult Intelligence Scale (WAIS-IV) < 85 or p < .05 between IWM and one of the WAIS-IV index;
    2. Less than 70% correct responses on Brown-Peterson tasks test in the verbal modality with an interfering task as mental calculation;
    3. Less than 89% correct responses on Brown-Peterson tasks test in the verbal modality with an interfering task of articulatory suppression;
    4. Less than 70% correct responses on Brown-Peterson tasks test in the visuospatial modality with an interfering motor task.
  • Prior medical examination;
  • Correct vision after visual acuity correction;
  • Stable neurological or psychoactive treatment for at least 4 weeks, if applicable;
  • Able to move to the center where rehabilitation will be performed;
  • Covered by a health insurance;
  • Signed consent of patient or of the guardian.

Exclusion Criteria:

  • History of central nervous system disorder, or history of psychological disorder or substance abuse;
  • Prior specific cognitive rehabilitation of working memory;
  • Instrumental activities disabilities, cognitive disorder, behavioural disorders or major psychiatric disorder;
  • Major anxio-depressive syndrome or present psychiatric disorder which can interfere with experimental procedure or measured variables;
  • Pregnant or breastfeeding woman.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Claire Vallat-Azouvi, PhD +33 1 47 10 76 47 claire.vallat-azouvi@univ-paris8.fr
Contact: Philippe Azouvi, MD, PhD +33 1 47 10 70 78 philippe.azouvi@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03874416
Other Study ID Numbers  ICMJE K160902J
PHRIP-16-0380 ( Other Identifier: Ministry of health )
2018-A02713-52 ( Registry Identifier: IDRCB (ANSM) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Claire Vallat-Azouvi, PhD Laboratoire LPN, EA2027-Université Paris 8, and Hôpital Raymond Poicaré-Antenne UEROS-UGECAMIDF
Study Director: Philippe Azouvi, MD, PhD Service Médecine Physique et de Réadaptation, Hôpital Raymond Poicaré, 92380 Garches
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP