TBI (Traumatic Brain Injury)NCT04590911
Effectiveness of Multimodal Cognitive Rehabilitation for Traumatic Brain Injury Sustained During Older Adulthood
A study testing Cognitive Enrichment Program (CEP) in people with TBI (Traumatic Brain Injury) and Rehabilitation, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- TBI (Traumatic Brain Injury), Rehabilitation, Aging
- What is being tested?
- Cognitive Enrichment Program (CEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2012to 1 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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];
- post-traumatic amnesia period must be already resolved;
- aged at least 55 years;
- fluent in French (speaking, understanding, reading).
Who cannot join
- previously received or receiving another specific or direct cognitive intervention focusing on similar or identical cognitive functions;
- diagnosis or documented clinical impressions of dementia (medical files) or Montreal Cognitive 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 5 or more days weekly in the past 30 days), or consuming illicit drugs.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Cognitive Enrichment Program (CEP)
- Keywords
- traumatic brain injury, cognitive rehabilitation, aging, memory, executive functions, psychological well-being, daily life activities
- Medical subject headings
- Brain Injuries, Traumatic, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Enrichment Program (CEP)Behavioural
Multimodal cognitive rehabilitation program for individuals having sustained a traumatic brain injury during older adulthood
| Study group | Role | What they receive |
|---|---|---|
| CEP intervention | Experimental | 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. Receives: Behavioral: Cognitive Enrichment Program (CEP) |
| Usual care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (T0) Face-name association (Côte-des-Neiges Computerized Memory Battery) at 14 weeks (post-intervention - T1)
Episodic memory measure where participants have to associate 12 previously learned face-name pairs.
Measured: 14 weeks (pre-post intervention - T0-T1)
Change from post-intervention (T1) Face-name association (Côte-des-Neiges Computerized Memory Battery) at 6 months post-intervention (follow-up - T2)
Episodic memory measure where participants have to associate 12 previously learned face-name pairs.
Measured: 6-months post-intervention (follow-up - T2)
Change from baseline (T0) Word list recall (Côte-des-Neiges Computerized Memory Battery) at 14 weeks (post-intervention - T1)
Episodic memory measure where participants have to associate 12 previously learned words. Measures of immediate and delayed recall were obtained.
Measured: 14 weeks (pre-post intervention - T0-T1)
Change from post-intervention (T1) Word list recall (Côte-des-Neiges Computerized Memory Battery) at 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.
Measured: 6-months post-intervention (follow-up - T2)
Change from baseline (T0) Text memory (Côte-des-Neiges Computerized Memory Battery) at 14 weeks (post-intervention - 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.
Measured: 14 weeks (pre-post intervention - T0-T1)
Change from post-intervention (T1) Text memory (Côte-des-Neiges Computerized Memory Battery) at 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.
Measured: 6-months post-intervention (follow-up - T2)
Change from baseline (T0) Self-Evaluation Memory Questionnaire (SEMQ) at 14 weeks (post-intervention - 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. Higher scores indicate worse outcome.
Measured: 14 weeks (pre-post intervention - T0-T1)
Change from post-intervention (T1) Self-Evaluation Memory Questionnaire (SEMQ) at 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. Higher scores indicate worse outcome.
Measured: 6-months post-intervention (follow-up - T2)
Change from baseline (T0) Six Elements Task-Adapted (SET-A) at 14 weeks (post-intervention - 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.
Measured: 14 weeks (pre-post intervention - T0-T1)
Change from post-intervention (T1) Six Elements Task-Adapted (SET-A) at 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.
Measured: 6-months post-intervention (follow-up - T2)
Change from baseline (T0) Sorting Test - Delis-Kaplan Executive Function System (D-KEFS) at 14 weeks (post-intervention - 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.
Measured: 14 weeks (pre-post intervention - T0-T1)
Change from post-intervention (T1) Sorting Test - Delis-Kaplan Executive Function System (D-KEFS) at 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.
Measured: 6-months post-intervention (follow-up - T2)
Change from baseline (T0) Stroop Test - Four-color version at 14 weeks (post-intervention - 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.
Measured: 14 weeks (pre-post intervention - T0-T1)
Change from post-intervention (T1) Stroop Test - Four-color version at 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.
Measured: 6-months post-intervention (follow-up - T2)
Change from baseline (T0) Dysexecutive Questionnaire (DEX) at 14 weeks (post-intervention - 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. Higher scores indicate worse outcome.
Measured: 14 weeks (pre-post intervention - T0-T1)
Change from post-intervention (T1) Dysexecutive Questionnaire (DEX) at 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. Higher scores indicate worse outcome.
Measured: 6-months post-intervention (follow-up - T2)
Change from baseline (T0) Psychological General Well-Being Index (PGWBI) at 14 weeks (post-intervention - T1)
Self-report measure where participants rate (0-6; low to high) their self-perceived well-being on 22 items. Higher scores indicate better outcome.
Measured: 14 weeks (pre-post intervention - T0-T1)
Change from post-intervention (T1) Psychological General Well-Being Index (PGWBI) at 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. Higher scores indicate better outcome.
Measured: 6-months post-intervention (follow-up - T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Sep 2012
- Primary completion1 Apr 2017
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Semi-randomized, controlled, before-after study with follow-up at six-months with blinded outcome measurement
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Responsible party
- Principal investigator, Michelle McKerral, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Investigators
- Michelle McKerral, PhD, Principal investigator, CRIR-IURDPM-CCSMTL and Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590911
- Sponsor's protocol ID
- CRIR
- Status last verified
- Aug 2024
- First submitted
- 5 Oct 2020
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34325040Cisneros 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.
PubMed 34303000
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Multimodal Cognitive Rehabilitation for Traumatic Brain Injury Sustained During Older Adulthood
- ClinicalTrials.gov ID
- NCT04590911
- Acronym / sponsor ID
- CRIR
- Conditions
- TBI (Traumatic Brain Injury), Rehabilitation, Aging
- Keywords
- traumatic brain injury, cognitive rehabilitation, aging, memory, executive functions, psychological well-being, daily life activities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater MontrealUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Semi-randomized, controlled, before-after study with follow-up at six-months with blinded outcome measurement
| Arm | Type | Receives |
|---|---|---|
| CEP intervention | Experimental | Behavioral: Cognitive Enrichment Program (CEP)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. |
| Usual care | No intervention | –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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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];
- post-traumatic amnesia period must be already resolved;
- aged at least 55 years;
- fluent in French (speaking, understanding, reading).
Key exclusion criteria (4 listed)
- previously received or receiving another specific or direct cognitive intervention focusing on similar or identical cognitive functions;
- diagnosis or documented clinical impressions of dementia (medical files) or Montreal Cognitive 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 5 or more days weekly in the past 30 days), or consuming illicit drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Enrichment Program (CEP)Multimodal cognitive rehabilitation program for individuals having sustained a traumatic brain injury during older adulthood | Behavioural | CEP intervention |
Primary outcome
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. Higher scores indicate worse outcome.
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. Higher scores indicate worse outcome.
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 - Delis-Kaplan Executive Function System (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 - Delis-Kaplan Executive Function System (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. Higher scores indicate worse outcome.
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. Higher scores indicate worse outcome.
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. Higher scores indicate better outcome.
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. Higher scores indicate better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Derived from this study: PubMed 34325040Cisneros 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.
- Derived from this study: PubMed 34303000Cisneros 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle McKerral, PhD principal investigator
CRIR-IURDPM-CCSMTL and Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Enrichment Program (CEP) in people with TBI (Traumatic Brain Injury) and Rehabilitation, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04590911, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.