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

NCT ID: NCT03874416

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2025-04-30

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.

Conditions

Moderate to Severe Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Specific rehabilitation of working memory

Specific rehabilitation of working memory according to hierarchized rehabilitation.

Group Type: EXPERIMENTAL

Specific rehabilitation

Intervention Type: OTHER

Experimental rehabilitation of working memory:

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

Control group

Non-specific rehabilitation of working memory, usual therapy.

Group Type: ACTIVE_COMPARATOR

Non-specific rehabilitation

Intervention Type: OTHER

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

Interventions

Specific rehabilitation

Experimental rehabilitation of working memory:

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

Intervention Type: 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.

Intervention Type: OTHER

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:

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claire Vallat-Azouvi, PhD

Role: PRINCIPAL_INVESTIGATOR

Laboratoire LPN, EA2027-Université Paris 8, and Hôpital Raymond Poicaré-Antenne UEROS-UGECAMIDF

Philippe Azouvi, MD, PhD

Role: STUDY_DIRECTOR

Service Médecine Physique et de Réadaptation, Hôpital Raymond Poicaré, 92380 Garches

Locations

Physical medicine and rehabilitation department, Raymond Poincaré Hospital

Garches, Hauts-de-seine, France

Site Status: RECRUITING

Countries

France

Central Contacts

Claire Vallat-Azouvi, PhD

Role: CONTACT

claire.vallat-azouvi@univ-paris8.fr

+33 1 47 10 76 47

Philippe Azouvi, MD, PhD

Role: CONTACT

philippe.azouvi@aphp.fr

+33 1 47 10 70 78

Facility Contacts

Claire Vallat-Azouvi, PhD

Role: primary

claire.vallat-azouvi@univ-paris8.fr

+ 33 1 47 10 76 47

Philippe Azouvi, MD, PhD

Role: backup

philippe.azouvi@aphp.fr

+ 33 1 47 10 70 78

Other Identifiers

PHRIP-16-0380

Identifier Type: OTHER

Identifier Source: secondary_id

2018-A02713-52

Identifier Type: REGISTRY

Identifier Source: secondary_id

K160902J

Identifier Type: -

Identifier Source: org_study_id