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

• ClinicalTrials.gov Identifier: NCT04590911
• Recruitment Status: Completed
• First Posted: October 19, 2020
• Last Update Posted: October 19, 2020
• Sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
• Collaborator: Fonds de la Recherche en Santé du Québec
• Information provided by (Responsible Party): Michelle McKerral, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Tracking Information

• First Submitted Date: October 5, 2020
• First Posted Date: October 19, 2020
• Last Update Posted Date: October 19, 2020
• Actual Study Start Date: September 1, 2012
• Actual Primary Completion Date: April 1, 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 9, 2020)

• Change from baseline (T0) Face-name association (Côte-des-Neiges Computerized Memory Battery) at 14 weeks (post-intervention - T1) [ Time Frame: 14 weeks (pre-post intervention - T0-T1) ]
  Episodic memory measure where participants have to associate 12 previously learned face-name pairs.
• Change from post-intervention (T1) Face-name association (Côte-des-Neiges Computerized Memory Battery) at 6 months post-intervention (follow-up - T2) [ Time Frame: 6-months post-intervention (follow-up - T2) ]
  Episodic memory measure where participants have to associate 12 previously learned face-name pairs.
• Change from baseline (T0) Word list recall (Côte-des-Neiges Computerized Memory Battery) at 14 weeks (post-intervention - T1) [ Time Frame: 14 weeks (pre-post intervention - T0-T1) ]
  Episodic memory measure where participants have to associate 12 previously learned words. Measures of immediate and delayed recall were obtained.
• Change from post-intervention (T1) Word list recall (Côte-des-Neiges Computerized Memory Battery) at 6-months post-intervention (follow-up - T2) [ Time Frame: 6-months post-intervention (follow-up - T2) ]
  Episodic memory measure where participants have to associate 12 previously learned words. Measures of immediate and delayed recall were obtained.
• Change from baseline (T0) Text memory (Côte-des-Neiges Computerized Memory Battery) at 14 weeks (post-intervention - T1) [ Time Frame: 14 weeks (pre-post intervention - T0-T1) ]
  Episodic memory measure where participants have to recall a short text, which is divided into 23 macrostructure elements (main ideas of the text giving a meaning to the story), and 24 microstructure elements (specific details about the story). Measures of immediate and delayed recall were obtained for macrostructure and microstructure elements.
• Change from post-intervention (T1) Text memory (Côte-des-Neiges Computerized Memory Battery) at 6-months post-intervention (follow-up - T2) [ Time Frame: 6-months post-intervention (follow-up - T2) ]
  Episodic memory measure where participants have to recall a short text, which is divided into 23 macrostructure elements (main ideas of the text giving a meaning to the story), and 24 microstructure elements (specific details about the story). Measures of immediate and delayed recall were obtained for macrostructure and microstructure elements.
• Change from baseline (T0) Self-Evaluation Memory Questionnaire (SEMQ) at 14 weeks (post-intervention - T1) [ Time Frame: 14 weeks (pre-post intervention - T0-T1) ]
  Self-report memory measure where participants rate (1 to 6; never to always) their memory performance for 10 dimensions for which are derived mean scores: Conversations, Books & movies, Slips of attention, People, Use of objects, Political & social events, Places, Actions to perform, Personal events, General.
• Change from post-intervention (T1) Self-Evaluation Memory Questionnaire (SEMQ) at 6-months post-intervention (follow-up - T2) [ Time Frame: 6-months post-intervention (follow-up - T2) ]
  Self-report memory measure where participants rate (1 to 6; never to always) their memory performance for 10 dimensions for which are derived mean scores: Conversations, Books & movies, Slips of attention, People, Use of objects, Political & social events, Places, Actions to perform, Personal events, General.
• Change from baseline (T0) Six Elements Task-Adapted (SET-A) at 14 weeks (post-intervention - T1) [ Time Frame: 14 weeks (pre-post intervention - T0-T1) ]
  Executive function measure where participants complete a task where the goal is to earn as many points as possible while following specific rules. Five dimensions are rated according to the degree of attainment (0-3) : Tackling the 6 subtasks, Inter-task balance, Avoiding rule-breaking, Checking time at appropriate moments, and Efficient behavior. The Total score (/15) is also computed.
• Change from post-intervention (T1) Six Elements Task-Adapted (SET-A) at 6-months post-intervention (follow-up - T2) [ Time Frame: 6-months post-intervention (follow-up - T2) ]
  Executive function measure where participants complete a task where the goal is to earn as many points as possible while following specific rules. Five dimensions are rated according to the degree of attainment (0-3) : Tackling the 6 subtasks, Inter-task balance, Avoiding rule-breaking, Checking time at appropriate moments, and Efficient behavior. The Total score (/15) is also computed.
• Change from baseline (T0) Sorting Test - D-KEFS at 14 weeks (post-intervention - T1) [ Time Frame: 14 weeks (pre-post intervention - T0-T1) ]
  Executive function measure where participant must sort cards with printed words into groups in as many ways as possible and describe their sorting criteria. Measures used are: Confirmed Correct Sort Total (CCS) raw score, Free Sorting Description (FSD) total raw score, and Time-Per-Sort Ratio (TSR) in seconds.
• Change from post-intervention (T1) Sorting Test - D-KEFS at 6-months post-intervention (follow-up - T2) [ Time Frame: 6-months post-intervention (follow-up - T2) ]
  Executive function measure where participant must sort cards with printed words into groups in as many ways as possible and describe their sorting criteria. Measures used are: Confirmed Correct Sort Total (CCS) raw score, Free Sorting Description (FSD) total raw score, and Time-Per-Sort Ratio (TSR) in seconds.
• Change from baseline (T0) Stroop Test - Four-color version at 14 weeks (post-intervention - T1) [ Time Frame: 14 weeks (pre-post intervention - T0-T1) ]
  Executive function measure where participant complete four tasks (reading, colors, inhibition and flexibility). The measures used (time, in seconds) are Inhibition of the Stroop effect by verbally indicating the color of the ink instead of reading the words, and Flexibility, where participants indicate the color of the ink and read the words when they appear in a box.
• Change from post-intervention (T1) Stroop Test - Four-color version at 6-months post-intervention (follow-up - T2) [ Time Frame: 6-months post-intervention (follow-up - T2) ]
  Executive function measure where participant complete four tasks (reading, colors, inhibition and flexibility). The measures used (time, in seconds) are Inhibition of the Stroop effect by verbally indicating the color of the ink instead of reading the words, and Flexibility, where participants indicate the color of the ink and read the words when they appear in a box.
• Change from baseline (T0) Dysexecutive Questionnaire (DEX) at 14 weeks (post-intervention - T1) [ Time Frame: 14 weeks (pre-post intervention - T0-T1) ]
  Self-report executive function measure where participants rate (0 to 5; never to always) their executive functioning on three scales: Executive cognition, Behavioural-Emotional Self-Regulation, and Metacognition. Self-awareness of executive difficulties was used as a measure of generalization by calculating the difference between participants' and a significant other's scores on the three subscales.
• Change from post-intervention (T1) Dysexecutive Questionnaire (DEX) at 6-months post-intervention (follow-up - T2) [ Time Frame: 6-months post-intervention (follow-up - T2) ]
  Self-report executive function measure where participants rate (0 to 5; never to always) their executive functioning on three scales: Executive cognition, Behavioural-Emotional Self-Regulation, and Metacognition. Self-awareness of executive difficulties was used as a measure of generalization by calculating the difference between participants' and a significant other's scores on the three subscales.
• Change from baseline (T0) Psychological General Well-Being Index (PGWBI) at 14 weeks (post-intervention - T1) [ Time Frame: 14 weeks (pre-post intervention - T0-T1) ]
  Self-report measure where participants rate (0-6; low to high) their self-perceived well-being on 22 items.
• Change from post-intervention (T1) Psychological General Well-Being Index (PGWBI) at 6-months post-intervention (follow-up - T2) [ Time Frame: 6-months post-intervention (follow-up - T2) ]
  Self-report measure where participants rate (0-6; low to high) their self-perceived well-being on 22 items.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Semi-randomized, controlled, before-after study with follow-up at six-months with blinded outcome measurement

Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Condition

• TBI (Traumatic Brain Injury)
• Rehabilitation
• Aging

Intervention

Behavioral: Cognitive Enrichment Program (CEP)

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

Study Arms

• Experimental: 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.
  Intervention: Behavioral: Cognitive Enrichment Program (CEP)
• No Intervention: 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 9, 2020): 42
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 1, 2015
• Actual Primary Completion Date: April 1, 2015 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 55 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT04590911
• Other Study ID Numbers: CRIR
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Michelle McKerral, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
• Study Sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
• Collaborators: Fonds de la Recherche en Santé du Québec

Investigators

• Principal Investigator: Michelle McKerral, PhD; CRIR-IURDPM-CCSMTL and Université de Montréal

• PRS Account: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
• Verification Date: October 2020