Effectiveness of Multimodal Cognitive Rehabilitation for Traumatic Brain Injury Sustained During Older Adulthood

Phase

N/A

Condition

Neurologic Disorders

Aging

Treatment

Cognitive Enrichment Program (CEP)

Clinical Study ID

NCT04590911

CRIR

Ages > 55
All Genders

Study Summary

In a worldwide context of accelerated demographic aging, traumatic brain injury (TBI) in older adults has become a public health problem. TBI incidence grows following an exponential curve as people get older, increasing the occurrence of TBI in ageing individuals. Rehabilitation programs used in clinical settings have generally been developed for younger adults, and their efficacy with older adults who sustain a TBI has not been evaluated. The investigators have tailored a modular cognitive rehabilitation program for individuals who sustain a TBI in older adulthood, the Cognitive Enrichment Program (CEP), by adapting approaches which have shown to be effective in normal ageing and with other neurological conditions. The aim of the study is to evaluate the effectiveness of the CEP in adults having sustained a TBI during later adulthood. Specific objectives are to evaluate the effectiveness on memory, executive functions, psychological well-being and daily life activities using psychometric tests, self-reported questionnaires, and daily life-like tasks. The investigators hypothesize that memory and executive functions training included in the CEP will result in an improvement in both psychometric and self-reported scores in a trained group of older individuals with TBI, whereas this will not be the case for a comparable TBI group who did not receive the CEP intervention.

Eligibility Criteria

Inclusion

Inclusion Criteria:

diagnosed with mild, moderate or severe TBI at least six months before enrolment instudy, based on the World Health Organization criteria [16]: Mild: length of loss oraltered level of consciousness (LOC) 0-30 minutes, Glasgow Coma Scale (GCS) score 13-15/15, negative or positive brain imaging (CT-Scan or MRI), post-traumaticamnesia (PTA) duration <24 hrs; Moderate: LOC 30 min-24 hrs, GCS score 9-12,positive brain imaging, PTA duration 1-14 days; Severe: LOC >24 h, GCS score 3-8,positive brain imaging, PTA duration >2 weeks [16];
post-traumatic amnesia period must be already resolved;
aged at least 55 years;
fluent in French (speaking, understanding, reading).

Exclusion

Exclusion Criteria:

previously received or receiving another specific or direct cognitive interventionfocusing on similar or identical cognitive functions;
diagnosis or documented clinical impressions of dementia (medical files) or MontrealCognitive Assessment score lower than 20;
diagnosis of an active psychiatric condition;
consumption of alcohol (drinking 5 or more drinks on the same occasion on each of 5or more days weekly in the past 30 days), or consuming illicit drugs.

Study Design

Cognitive Enrichment Program (CEP)

September 01, 2012

April 01, 2018

Study Description

This study aims to evaluate the impact of a multimodal cognitive intervention, the Cognitive Enrichment Program (CEP), on episodic memory, executive functions, psychological well-being and daily life activities in traumatic brain injured (TBI) older adults, as compared to an active control group that receives only usual care in the form of holistic rehabilitation. The experimental design is a semi-randomized, controlled, before-after study with blinded outcome measurement. French-speaking participants aged 55 years or older and having sustained a mild, moderate or severe TBI at least 6 months before enrollment, were recruited by clinical coordinators from one hospital and from two outpatient interdisciplinary rehabilitation centres. The CEP consists of three intervention modules, Introduction and self-awareness, Attention and Memory, and Executive functions, which were conducted with groups of 5 participants, in 90-minute sessions, twice weekly, during 12 weeks. The CEP was conducted by an experienced clinical neuropsychologist. Assessments of intervention effects were performed by trained evaluators, who were blinded to group assignment of participants, in two separate sessions lasting about 90 minutes each. There were three assessment time-points: baseline (pre-intervention - T0); 14-weeks (post-intervention - T1); 6-months post-intervention (follow-up - T2). Primary outcome measures (neuropsychological and self-report) were chosen to measure targeted effects of the CEP and generalization measures (self-report) were used to evaluate broader effects of the intervention. Control measures were also used to control for spontaneous recovery.

Connect with a study center

Iurdpm-Ccsmtl
Montreal, Quebec H3S1M9
Canada
Site Not Available

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