Clinical trial NCT04590911: Effectiveness of Multimodal Cognitive Rehabilitation for Traumatic Brain Injury Sustained During Older Adulthood
Official title: Effectiveness of Multimodal Cognitive Rehabilitation for Traumatic Brain Injury Sustained During Older Adulthood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Rehabilitation
Aging
Keywords: traumatic brain injury
cognitive rehabilitation
aging
memory
executive functions
psychological well-being
daily life activities
Lead sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
First posted: 2020-10-19
Enrollment: 42
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Semi-randomized, controlled, before-after study with follow-up at six-months with blinded outcome measurement
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline (T0) Face-name association (Côte-des-Neiges Computerized Memory Battery) at 14 weeks (post-intervention - T1)
timeFrame: 14 weeks (pre-post intervention - T0-T1)
measure: Change from post-intervention (T1) Face-name association (Côte-des-Neiges Computerized Memory Battery) at 6 months post-intervention (follow-up - T2)
timeFrame: 6-months post-intervention (follow-up - T2)
measure: Change from baseline (T0) Word list recall (Côte-des-Neiges Computerized Memory Battery) at 14 weeks (post-intervention - T1)
timeFrame: 14 weeks (pre-post intervention - T0-T1)
measure: Change from post-intervention (T1) Word list recall (Côte-des-Neiges Computerized Memory Battery) at 6-months post-intervention (follow-up - T2)
timeFrame: 6-months post-intervention (follow-up - T2)
measure: Change from baseline (T0) Text memory (Côte-des-Neiges Computerized Memory Battery) at 14 weeks (post-intervention - T1)
timeFrame: 14 weeks (pre-post intervention - T0-T1)
measure: Change from post-intervention (T1) Text memory (Côte-des-Neiges Computerized Memory Battery) at 6-months post-intervention (follow-up - T2)
timeFrame: 6-months post-intervention (follow-up - T2)
measure: Change from baseline (T0) Self-Evaluation Memory Questionnaire (SEMQ) at 14 weeks (post-intervention - T1)
timeFrame: 14 weeks (pre-post intervention - T0-T1)
measure: Change from post-intervention (T1) Self-Evaluation Memory Questionnaire (SEMQ) at 6-months post-intervention (follow-up - T2)
timeFrame: 6-months post-intervention (follow-up - T2)
measure: Change from baseline (T0) Six Elements Task-Adapted (SET-A) at 14 weeks (post-intervention - T1)
timeFrame: 14 weeks (pre-post intervention - T0-T1)
measure: Change from post-intervention (T1) Six Elements Task-Adapted (SET-A) at 6-months post-intervention (follow-up - T2)
timeFrame: 6-months post-intervention (follow-up - T2)
measure: Change from baseline (T0) Sorting Test - Delis-Kaplan Executive Function System (D-KEFS) at 14 weeks (post-intervention - T1)
timeFrame: 14 weeks (pre-post intervention - T0-T1)
measure: Change from post-intervention (T1) Sorting Test - Delis-Kaplan Executive Function System (D-KEFS) at 6-months post-intervention (follow-up - T2)
timeFrame: 6-months post-intervention (follow-up - T2)
measure: Change from baseline (T0) Stroop Test - Four-color version at 14 weeks (post-intervention - T1)
timeFrame: 14 weeks (pre-post intervention - T0-T1)
measure: Change from post-intervention (T1) Stroop Test - Four-color version at 6-months post-intervention (follow-up - T2)
timeFrame: 6-months post-intervention (follow-up - T2)
measure: Change from baseline (T0) Dysexecutive Questionnaire (DEX) at 14 weeks (post-intervention - T1)
timeFrame: 14 weeks (pre-post intervention - T0-T1)
measure: Change from post-intervention (T1) Dysexecutive Questionnaire (DEX) at 6-months post-intervention (follow-up - T2)
timeFrame: 6-months post-intervention (follow-up - T2)
measure: Change from baseline (T0) Psychological General Well-Being Index (PGWBI) at 14 weeks (post-intervention - T1)
timeFrame: 14 weeks (pre-post intervention - T0-T1)
measure: Change from post-intervention (T1) Psychological General Well-Being Index (PGWBI) at 6-months post-intervention (follow-up - T2)
timeFrame: 6-months post-intervention (follow-up - T2)
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Iurdpm-Ccsmtl
state: Quebec
Study officials:
affiliation: CRIR-IURDPM-CCSMTL and Université de Montréal
name: Michelle McKerral, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.