NCT03874416

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-25
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2019-03-14
• Last updated: 2023-09-06

Locations

1 site across 1 country: France