Back to resultsCognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury (REHAB-MDT)
Primary Purpose
Moderate to Severe Traumatic Brain Injury
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Specific rehabilitation
Non-specific rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe Traumatic Brain Injury focused on measuring moderate to severe traumatic brain injury, cognitive rehabilitation, working memory, daily life function, Working Memory Questionnaire, WMQ, Brown-Peterson test
Eligibility Criteria
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:
- 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;
- Less than 70% correct responses on Brown-Peterson tasks test in the verbal modality with an interfering task as mental calculation;
- Less than 89% correct responses on Brown-Peterson tasks test in the verbal modality with an interfering task of articulatory suppression;
- 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.
Sites / Locations
- Physical medicine and rehabilitation department, Raymond Poincaré HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Specific rehabilitation of working memory
Control group
Arm Description
Specific rehabilitation of working memory according to hierarchized rehabilitation.
Non-specific rehabilitation of working memory, usual therapy.
Outcomes
Primary Outcome Measures
Proportions of simultaneous responders
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.
Secondary Outcome Measures
Working Memory Questionnaire during rehabilitation program
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
Working memory span tasks
Cognitive task of working memory
Verbal and visuospatial working memory.
Cognitive task of working memory
n-back task
Cognitive task of working memory
Brown-Peterson Visual.
Cognitive task of working memory
reading span task.
Cognitive task of working memory
Working Memory Index (WISC-IV).
Cognitive task of working memory
divided attention task
Arithmetic resolution
Non-specific tasks involving working memory: arithmetic resolution ability by WAIS index
Non-targeted cognitive measurements
Executive functions will be assessed.
Non-targeted cognitive measurements
Long-term memory will be assessed.
Non-targeted cognitive measurements
The speed of treatment will be assessed.
Social functioning assessement
Assessed by Manual for Sydney Psychosocial Reintegration Scale (SPRS)
Quality of life assessment
Assessed by Qolibri scale
Quality of life assessment
Assessed by EQ5D-5
Acceptability
Compliance of rehabilitation program: duration of training of speech-language pathologist and psychologist to the rehabilitation program.
Acceptability
Compliance of rehabilitation program: duration of session.
Acceptability
Compliance of rehabilitation program: patient's satisfaction of care (Client Satisfaction Questionnaire (CSQ-8)).
Acceptability
Compliance of rehabilitation program: presence during rehabilitation session of working memory.
Full Information
NCT ID
NCT03874416
First Posted
February 4, 2019
Last Updated
September 4, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03874416
Brief Title
Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury
Acronym
REHAB-MDT
Official Title
A Randomized Controlled Trial of Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Traumatic Brain Injury
Keywords
moderate to severe traumatic brain injury, cognitive rehabilitation, working memory, daily life function, Working Memory Questionnaire, WMQ, Brown-Peterson test
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blind trial with 2 parallel arms:
Specific rehabilitation of working memory vs. non-specific rehabilitation
Masking
Outcomes Assessor
Masking Description
Clinical assessment will be performed by an assessor blinded to group allocation.
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Specific rehabilitation of working memory
Arm Type
Experimental
Arm Description
Specific rehabilitation of working memory according to hierarchized rehabilitation.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Non-specific rehabilitation of working memory, usual therapy.
Intervention Type
Other
Intervention Name(s)
Specific rehabilitation
Intervention Description
Experimental rehabilitation of working memory:
3 sessions per week during 3 months, for a total 36 sessions.
Intervention Type
Other
Intervention Name(s)
Non-specific rehabilitation
Intervention Description
Usual non-specific rehabilitation treatment for moderate to severe TBI in healthcare facilities: 2-3 sessions per week for 3 months.
Primary Outcome Measure Information:
Title
Proportions of simultaneous responders
Description
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.
Time Frame
3 months after the first rehabilitation session
Secondary Outcome Measure Information:
Title
Working Memory Questionnaire during rehabilitation program
Description
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.
Time Frame
At baseline, 3 months, 6 months and 9 months
Title
Cognitive task of working memory
Description
Working memory span tasks
Time Frame
At baseline, 3 months, 6 months and 9 months
Title
Cognitive task of working memory
Description
Verbal and visuospatial working memory.
Time Frame
At baseline, 3 months, 6 months and 9 months
Title
Cognitive task of working memory
Description
n-back task
Time Frame
At baseline, 3 months, 6 months and 9 months
Title
Cognitive task of working memory
Description
Brown-Peterson Visual.
Time Frame
At baseline, 3 months, 6 months and 9 months
Title
Cognitive task of working memory
Description
reading span task.
Time Frame
At baseline, 3 months, 6 months and 9 months
Title
Cognitive task of working memory
Description
Working Memory Index (WISC-IV).
Time Frame
At baseline, 3 months, 6 months and 9 months
Title
Cognitive task of working memory
Description
divided attention task
Time Frame
At baseline, 3 months, 6 months and 9 months
Title
Arithmetic resolution
Description
Non-specific tasks involving working memory: arithmetic resolution ability by WAIS index
Time Frame
At baseline, 3 months and 6 months
Title
Non-targeted cognitive measurements
Description
Executive functions will be assessed.
Time Frame
At baseline, 3 months and 6 months
Title
Non-targeted cognitive measurements
Description
Long-term memory will be assessed.
Time Frame
At baseline, 3 months and 6 months
Title
Non-targeted cognitive measurements
Description
The speed of treatment will be assessed.
Time Frame
At baseline, 3 months and 6 months
Title
Social functioning assessement
Description
Assessed by Manual for Sydney Psychosocial Reintegration Scale (SPRS)
Time Frame
At baseline, 3 months, 6 months and 9 months
Title
Quality of life assessment
Description
Assessed by Qolibri scale
Time Frame
At baseline, 3 months, 6 months and 9 months
Title
Quality of life assessment
Description
Assessed by EQ5D-5
Time Frame
At baseline, 3 months, 6 months and 9 months
Title
Acceptability
Description
Compliance of rehabilitation program: duration of training of speech-language pathologist and psychologist to the rehabilitation program.
Time Frame
At baseline, 3 months and 6 months
Title
Acceptability
Description
Compliance of rehabilitation program: duration of session.
Time Frame
At baseline, 3 months and 6 months
Title
Acceptability
Description
Compliance of rehabilitation program: patient's satisfaction of care (Client Satisfaction Questionnaire (CSQ-8)).
Time Frame
At baseline, 3 months and 6 months
Title
Acceptability
Description
Compliance of rehabilitation program: presence during rehabilitation session of working memory.
Time Frame
At baseline, 3 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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;
Less than 70% correct responses on Brown-Peterson tasks test in the verbal modality with an interfering task as mental calculation;
Less than 89% correct responses on Brown-Peterson tasks test in the verbal modality with an interfering task of articulatory suppression;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Vallat-Azouvi, PhD
Phone
+33 1 47 10 76 47
Email
claire.vallat-azouvi@univ-paris8.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Azouvi, MD, PhD
Phone
+33 1 47 10 70 78
Email
philippe.azouvi@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Vallat-Azouvi, PhD
Organizational Affiliation
Laboratoire LPN, EA2027-Université Paris 8, and Hôpital Raymond Poicaré-Antenne UEROS-UGECAMIDF
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philippe Azouvi, MD, PhD
Organizational Affiliation
Service Médecine Physique et de Réadaptation, Hôpital Raymond Poicaré, 92380 Garches
Official's Role
Study Director
Facility Information:
Facility Name
Physical medicine and rehabilitation department, Raymond Poincaré Hospital
City
Garches
State/Province
Hauts-de-seine
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Vallat-Azouvi, PhD
Phone
+ 33 1 47 10 76 47
Email
claire.vallat-azouvi@univ-paris8.fr
First Name & Middle Initial & Last Name & Degree
Philippe Azouvi, MD, PhD
Phone
+ 33 1 47 10 70 78
Email
philippe.azouvi@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury
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