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Moderate to Severe Traumatic Brain InjuryREHAB-MDTNCT03874416

Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury

A study testing Specific rehabilitation and Non-specific rehabilitation in people with Moderate to Severe Traumatic Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Specific rehabilitation and Non-specific rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteFrance
Study dates
25 Jan 2021to Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Claire Vallat-Azouvi, PhD contact

+33 1 47 10 76 47

claire.vallat-azouvi@univ-paris8.fr

Philippe Azouvi, MD, PhD contact

+33 1 47 10 70 78

philippe.azouvi@aphp.fr

France1 site, 1 recruiting

  • Physical medicine and rehabilitation department, Raymond Poincaré Hospital

    Garches, Hauts-de-seine, 92380

    Claire Vallat-Azouvi, PhD, + 33 1 47 10 76 47, claire.vallat-azouvi@univ-paris8.fr

    Philippe Azouvi, MD, PhD, + 33 1 47 10 70 78, philippe.azouvi@aphp.fr

    Recruiting

Other trials in France

About this study

Official title: A Randomized Controlled Trial of Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury

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.
Read the 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.

Being tested
Specific rehabilitation, Non-specific rehabilitation
Keywords
moderate to severe traumatic brain injury, cognitive rehabilitation, working memory, daily life function, Working Memory Questionnaire, WMQ, Brown-Peterson test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Specific rehabilitationOther

    Experimental rehabilitation of working memory:

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

  • Non-specific rehabilitationOther

    Usual non-specific rehabilitation treatment for moderate to severe TBI in healthcare facilities: 2-3 sessions per week for 3 months.

Study groups in NCT03874416
Study groupRoleWhat they receive
Specific rehabilitation of working memoryExperimentalSpecific rehabilitation of working memory according to hierarchized rehabilitation.
Receives: Other: Specific rehabilitation
Control groupActive comparatorNon-specific rehabilitation of working memory, usual therapy.
Receives: Other: Non-specific rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months after the first rehabilitation session

Secondary outcomes (19)

  1. 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.

    Measured: At baseline, 3 months, 6 months and 9 months

  2. Cognitive task of working memory

    Working memory span tasks

    Measured: At baseline, 3 months, 6 months and 9 months

  3. Cognitive task of working memory

    Verbal and visuospatial working memory.

    Measured: At baseline, 3 months, 6 months and 9 months

  4. Cognitive task of working memory

    n-back task

    Measured: At baseline, 3 months, 6 months and 9 months

  5. Cognitive task of working memory

    Brown-Peterson Visual.

    Measured: At baseline, 3 months, 6 months and 9 months

  6. Cognitive task of working memory

    reading span task.

    Measured: At baseline, 3 months, 6 months and 9 months

  7. Cognitive task of working memory

    Working Memory Index (WISC-IV).

    Measured: At baseline, 3 months, 6 months and 9 months

  8. Cognitive task of working memory

    divided attention task

    Measured: At baseline, 3 months, 6 months and 9 months

  9. Arithmetic resolution

    Non-specific tasks involving working memory: arithmetic resolution ability by WAIS index

    Measured: At baseline, 3 months and 6 months

  10. Non-targeted cognitive measurements

    Executive functions will be assessed.

    Measured: At baseline, 3 months and 6 months

  11. Non-targeted cognitive measurements

    Long-term memory will be assessed.

    Measured: At baseline, 3 months and 6 months

  12. Non-targeted cognitive measurements

    The speed of treatment will be assessed.

    Measured: At baseline, 3 months and 6 months

  13. Social functioning assessement

    Assessed by Manual for Sydney Psychosocial Reintegration Scale (SPRS)

    Measured: At baseline, 3 months, 6 months and 9 months

  14. Quality of life assessment

    Assessed by Qolibri scale

    Measured: At baseline, 3 months, 6 months and 9 months

  15. Quality of life assessment

    Assessed by EQ5D-5

    Measured: At baseline, 3 months, 6 months and 9 months

  16. Acceptability

    Compliance of rehabilitation program: duration of training of speech-language pathologist and psychologist to the rehabilitation program.

    Measured: At baseline, 3 months and 6 months

  17. Acceptability

    Compliance of rehabilitation program: duration of session.

    Measured: At baseline, 3 months and 6 months

  18. Acceptability

    Compliance of rehabilitation program: patient's satisfaction of care (Client Satisfaction Questionnaire (CSQ-8)).

    Measured: At baseline, 3 months and 6 months

  19. Acceptability

    Compliance of rehabilitation program: presence during rehabilitation session of working memory.

    Measured: At baseline, 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2019
  2. Study start25 Jan 2021
  3. Primary completionApr 2025 (estimated)
  4. Study completionApr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single blind trial with 2 parallel arms: Specific rehabilitation of working memory vs. non-specific rehabilitation
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03874416
Sponsor's protocol ID
K160902J
Other IDs
PHRIP-16-0380, 2018-A02713-52
Acronym
REHAB-MDT
Status last verified
Sep 2023
First submitted
4 Feb 2019
Last updated
6 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Specific rehabilitation and Non-specific rehabilitation in people with Moderate to Severe Traumatic Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Claire Vallat-Azouvi, PhD (+33 1 47 10 76 47, claire.vallat-azouvi@univ-paris8.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportions of simultaneous responders (time frame: 3 months after the first rehabilitation session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03874416.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.

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