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

NCT ID: NCT04590911

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-01
• Study Completion Date: 2018-04-01

Brief 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.

Detailed 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.

Conditions

TBI (Traumatic Brain Injury); Rehabilitation; Aging

Study Design

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

Study Groups

CEP intervention

Cognitive Enrichment Program (CEP) : tailored for individuals who sustain a TBI in later adulthood. The CEP is a 12-week multimodal intervention structured into three modules designed to simultaneously address cognitive problems resulting from TBI, as well as age-related cognitive issues in the following domains: self-awareness, attention and memory, and executive functions.

Group Type: EXPERIMENTAL

Cognitive Enrichment Program (CEP)

Intervention Type: BEHAVIORAL

Multimodal cognitive rehabilitation program for individuals having sustained a traumatic brain injury during older adulthood

Usual care

Usual care : interventions within a holistic interdisciplinary rehabilitation program focused on resuming daily activities and social roles, if needed, as determined by treating physician; does not include any form of cognitive rehabilitation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Enrichment Program (CEP)

Multimodal cognitive rehabilitation program for individuals having sustained a traumatic brain injury during older adulthood

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. diagnosed with mild, moderate or severe TBI at least six months before enrolment in study, based on the World Health Organization criteria [16]: Mild: length of loss or altered 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-traumatic amnesia (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];

2. post-traumatic amnesia period must be already resolved;

3. aged at least 55 years;

4. fluent in French (speaking, understanding, reading).

Exclusion Criteria

1. previously received or receiving another specific or direct cognitive intervention focusing on similar or identical cognitive functions;

2. diagnosis or documented clinical impressions of dementia (medical files) or Montreal Cognitive Assessment score lower than 20;

3. diagnosis of an active psychiatric condition;

4. consumption of alcohol (drinking 5 or more drinks on the same occasion on each of 5 or more days weekly in the past 30 days), or consuming illicit drugs.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role: collaborator

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

OTHER

Sponsor Role: lead

Responsible Party

Michelle McKerral

Professor and Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle McKerral, PhD

Role: PRINCIPAL_INVESTIGATOR

CRIR-IURDPM-CCSMTL and Université de Montréal

Locations

Iurdpm-Ccsmtl

Montreal, Quebec, Canada

Countries

Canada

References

Cisneros E, de Guise E, Belleville S, McKerral M. A controlled clinical efficacy trial of multimodal cognitive rehabilitation on episodic memory functioning in older adults with traumatic brain injury. Ann Phys Rehabil Med. 2021 Sep;64(5):101563. doi: 10.1016/j.rehab.2021.101563. Epub 2021 Aug 5.

Reference Type: DERIVED

PMID: 34325040 (View on PubMed)

Cisneros E, Beausejour V, de Guise E, Belleville S, McKerral M. The impact of multimodal cognitive rehabilitation on executive functions in older adults with traumatic brain injury. Ann Phys Rehabil Med. 2021 Sep;64(5):101559. doi: 10.1016/j.rehab.2021.101559. Epub 2021 Aug 5.

Reference Type: DERIVED

PMID: 34303000 (View on PubMed)

Other Identifiers

CRIR

Identifier Type: -

Identifier Source: org_study_id