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

NCT03874416 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-09-06

No results posted yet for this study

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.

Conditions

  • Moderate to Severe Traumatic Brain Injury

Interventions

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Claire Vallat-Azouvi, PhD · Laboratoire LPN, EA2027-Université Paris 8, and Hôpital Raymond Poicaré-Antenne UEROS-UGECAMIDF

  • Philippe Azouvi, MD, PhD · Service Médecine Physique et de Réadaptation, Hôpital Raymond Poicaré, 92380 Garches

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-25
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03874416 on ClinicalTrials.gov