Acquired Brain InjuryI-PRESSNCT04882215
Integrated PRocess and StrategieS Training: I-PRESS Training
A study testing GMT combined with WMU Training in people with Acquired Brain Injury, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
There is a pressing need to develop more effective interventions to remediate cognitive deficits in highly prevalent disabling conditions such as stroke, head injury and other forms of acquired brain injury (ABI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- GMT combined with WMU Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 May 2020to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only those able to give informed consent and able to comply with the training protocol will be included.
- ≥ 6 months post-ABI at time of recruitment (expression of interest to participate either verbally or in writing)
- Adults over the age of 18.
- English language fluency (speaking)
- a combination of self/relative/friend/carer reports of everyday organisation/memory problems
Who cannot join
- Individuals with contra-indications to MRI (e.g. heart pacemaker)
- Comorbid progressive neurological disorder or neurodegenerative condition (e.g. dementia)
- Major psychiatric disorder considered likely to prevent engagement in the intervention programme (pre-ABI history of mood disorder or stable antidepressant medication will not lead to exclusion)
- History of major substance abuse problems likely to prevent engagement in the intervention programme
- Unable to give informed consent
- Unable to cooperate with the study protocol (e.g. severe impairment of hearing, vision or language)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Lead Communirty Brain Injury Team NHS Lanarkshire Law House Airdrie Road
Carluke, Lanarkshire, ML8 5EP
About this study
Official title: Development and Evaluation of a Novel Treatment Intervention for People With Acquired Brain Injury
There is a pressing need to develop more effective interventions to remediate cognitive deficits in highly prevalent disabling conditions such as stroke, head injury and other forms of acquired brain injury (ABI). Neuropsychological rehabilitation interventions developed in a clinical setting have shown some beneficial effects, but the effectiveness of clinical interventions have potential to be enhanced if informed by findings from cognitive neuroscience. Research into cognitive training using methods such as functional magnetic resonance imaging (fMRI) has contributed to an understanding of factors that promote changes in brain function, but this approach seldom includes individuals with brain damage or cognitive deficits. Its potential for application with clinical populations is therefore uncertain, meaning that people who may benefit do not have access to interventions that may improve their health and wellbeing.
The proposed research brings together methods from neuropsychological rehabilitation and cognitive neuroscience to investigate 1) the feasibility of, and effect sizes arising from, combining an existing clinical intervention targeting mental strategies with an adaptive training programme targeting core cognitive processes, and 2) whether the novel treatment combination promotes changes in brain function that are detectable using fMRI.
This project will develop and evaluate a training intervention that aims to improve outcomes from a strategy-based rehabilitation intervention, Goal Management Training (GMT), by adding process-based cognitive training with adaptive difficulty to enhance the executive function of working memory updating (WMU). People with ABI (n=32) will complete 9 sessions of GMT, a recommended treatment for deficits in frontal-lobe executive functions, with the addition of 8 WMU training sessions with or without adaptive training. Measures of feasibility, acceptability, and fidelity will be taken, and effect sizes of differences in pre- to post-training changes on neural, cognitive, and functional measurements will be determined by comparing two experimental groups in which difficulty of the WMU training tasks either adaptively increases in response to performance or is fixed.
Read the detailed description
Globally, stroke and head injury are leading causes of disability. Deficits in cognitive functions are common in these conditions, including impairment in frontal-lobe 'executive' functions such as working memory and the ability to solve problems, plan, and regulate actions in order to achieve intended goals. These deficits affect individuals' ability to live independently, work, and maintain social relationships. We propose that improving outcomes for people with acquired brain injury (ABI) requires an interdisciplinary approach in which neuropsychological rehabilitation and cognitive neuroscience complement one another.
In neuropsychological rehabilitation, interventions are classified as 'restorative' (restoration of underlying core cognitive processes including executive functions) or 'compensatory' (compensation of function through the use of external aids or learned strategies). Clinical guidelines recommend the use of 'meta-cognitive strategy training' for the treatment of deficits in frontal-lobe executive functions. Goal Management Training (GMT) is one such validated meta-cognitive strategy. GMT trains compensatory mental strategies to manage attention during multi-step tasks. GMT has been evaluated behaviourally in randomised controlled trials with positive, albeit modest, outcomes in individuals with ABI.
In cognitive neuroscience, an emerging research area concerns experience-induced neural changes referred to as neural plasticity. These may involve neural changes in: 1) task-based functional activation patterns, i.e. activity increases, decreases, or reorganisation, 2) brain structure, i.e., grey matter and white matter volume changes and 3) functional connectivity, i.e. changes in connectivity between brain regions that are recruited for a mental procedure as well as changes in the strength and magnitude.
Neuroimaging studies have demonstrated that programmes to train core cognitive processes including working memory (WM) executive functions can drive changes both in behavioural and neural measures. Performance gains after process-based training have been observed by several authors employing different training tasks and including both younger and older populations. In addition, generalisation to broad cognitive abilities such as reasoning, episodic memory, after process-based training, has been observed in both young and older adults although this area is under debate. This work has primarily involved healthy adults and whether the same findings apply to those with ABI needs to be investigated.
This research study aims to develop and evaluate a novel treatment intervention for people with ABI that combines a process-based cognitive training with a strategy-based GMT rehabilitation intervention, and to acquire functional magnetic resonance imaging (fMRI) data before and after the intervention to measure patterns of brain activity associated with a task requiring executive functions. We propose that outcomes from GMT might be improved by an adaptive, process-based intervention aimed at enhancing working memory processes. Adaptive task difficulty involves dynamic adjustment of training task demands so that the individual remains within an optimal range of performance.
- Aims
The primary aim of the study is to investigate whether it is feasible and acceptable to deliver a novel intervention combining GMT with WMU training, within a randomised controlled trial (RCT) context in a sample of ABI individuals. A further aim is to examine the behavioural and neural changes related to the novel intervention as well as the effect sizes.
ii. Research Question
This project will combine methods from neuropsychological rehabilitation and cognitive neuroscience to answer the following: 1) Is it feasible to combine an existing treatment for executive dysfunction, GMT, with an adaptive WMU training and how much benefit is gained? 2) Does the novel treatment combination promote neural plasticity that is detectable using fMRI?
iii. Outcomes
Primary outcomes will be measures of feasibility, acceptability, and fidelity.
Secondary outcomes will be pre- to post-training change in behavioural data (i.e., neuro-psychological assessment battery, measures of cognitive task performance and everyday functioning) and fMRI data (i.e., task-related brain activity), analysed by training condition. In addition, exploratory analyses of individual differences in responsiveness to WMU training will be performed, by calculating correlations between amount of adaptive training task improvement and pre- to post-training change on neural, cognitive, and functional measurements.
iv. Design
Randomised controlled trial methodology; specifically stratified randomisation in conjunction with permuted block random allocation, using an active control group will compare two conditions: (1) GMT combined with adaptive training [AT]; (2) GMT combined with non-adaptive [NA] training. Thirty-two adults with non-progressive ABI sustained in adulthood will be recruited from the NHS.. Participants will complete a combination of standard GMT (9 sessions) and 8 WMU (AT or NA) training sessions, delivered in small groups. Neuropsychological and functional assessments will be performed before and after the intervention. In addition, fMRI scanning sessions will be conducted pre- and post-training
- Conditions
- Acquired Brain Injury
- Being tested
- GMT combined with WMU Training
- Keywords
- Traumatic Brain Injury, Stroke, executive dysfunction
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMT combined with WMU TrainingBehavioural
GMT teaches the use of mental strategies to support sustained attention during complex (multi-step) task performance following an interactive programme. GMT is structured into nine modules, with interactive discussions and homework assignments. It will be conducted on a group basis.
WMU training consists of computerised working memory updating tasks in which trial accuracy and response time are recorded. Two tasks will be trained: 1. a visuo-spatial Matrix Updating (MU) and 2. a verbal Keep Track (KT). For both training tasks, level of difficulty can be modulated by increasing or decreasing the update level, i.e., the number of updates on each trial.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Training (AT) | Experimental | For AT participants, difficulty of the training tasks is progressively increased in response to task performance. Receives: Behavioral: GMT combined with WMU Training |
| Non Adaptive Training (NA) | Active comparator | For NA participants, task difficulty is fixed at a relatively low level across all sessions. Receives: Behavioral: GMT combined with WMU Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Recruitment Process.
Number of people referred from NHS eligible for screening and those entering the intervention. This will be continuously monitored throughout the study period.
Measured: From pre-intervention (Week 1) to post-intervention (Week 12).
Participants' Drop-out Rates
Number of people completing the intervention to assess drop-out rates. This will be continuously monitored throughout the study period.
Measured: From pre-intervention (Week 1) to post-intervention (Week 12).
Participants' Coherence and Adherence to the Intervention.
Mean percentage of working memory training sessions completed (a total of eight) were calculated across participants.
Measured: From pre-intervention (Week 1) to post-intervention (Week 12).
Feedback Questionnaire
Participant evaluation of the intervention using a study-specific questionnaire including eight 5-point Likert-scale agreement questions (scores of 1 to 5 with 1 being positive and 5 being negative). Mean feedback score was calculated across participants.
Measured: Post-intervention session (Week 12)
Secondary outcomes (8)
Visuospatial Working Memory Using the Visuospatial Matrix Updating fMRI Task
Performance in visuospatial working memory using the visuospatial Matrix Updating fMRI task. Accuracy is calculated as the proportion of correct responses at low and high difficulty task trials. Post-intervention session was used to calculate this measure.
Measured: Post-intervention session (week 12)
Visuospatial Working Memory fMRI Task Accuracy Using the Spatial N-back fMRI Task
Performance on spatial working memory using the spatial n-back fMRI task as calculated by proportion of correct responses at low and high difficulty n-back task trials. Post-intervention session was used to calculate this measure.
Measured: Post-intervention session (Week 12)
Episodic Visual Memory Accuracy Using the Object-location Association fMRI Task.
Performance on visual episodic memory using the Object-location association fMRI task calculated by the proportion of correct responses at low and high difficulty level task trials. Post-intervention session was used to calculate this measure.
Measured: Post-intervention session (Week 12)
Changes in Shifting Attention Using the Intra-Extra Dimensional Set Shift Test Variant From CANTAB Connect Research Web-testing.
Number of trials for which the outcome was an incorrect response (subject pressed the incorrect button within the response window), calculated across all assessed trials. Higher score indicates a worse outcome. Mean percentage change between pre and post intervention scores was calculated across participants.
Measured: Pre-intervention (Week 1) and post-intervention (Week 12)
Changes in Spatial Planning and Problem Solving Using the Stockings of Cambridge Test Variant From CANTAB Connect Research Web-testing.
Number of assessed problems that the participant successfully completed in the minimum possible number of moves. Calculated over all assessed trials. Higher score indicates a better outcome. Mean percentage change between pre and post intervention scores was calculated across participants.
Measured: Pre-intervention (Week 1) and post-intervention (Week 12)
Changes in Spatial Working Memory Using the Spatial Working Memory Test Variant From CANTAB Connect Research Web-testing.
The number of times the subject incorrectly revisits a box in which a token has previously been found. Calculated across all assessed four, six and eight token trials. Higher score indicates a worse outcome. Mean percentage change between pre and post intervention scores was calculated across participants.
Measured: Pre-intervention (Week 1) and post-intervention (Week 12)
Changes in Visuospatial Working Memory Using the Spatial Span Forward Test Variant From CANTAB Connect Research Web-testing.
The Spatial Span forward test variant from CANTAB connect research web-testing was used calculated by the longest sequence of boxes successfully recalled by the participant. Higher score indicates a better outcome. Mean percentage change between pre and post intervention scores was calculated across participants.
Measured: Pre-intervention (Week 1) and post-intervention (Week 12)
Changes in Visuospatial Working Memory Using the Spatial Span Reverse Test Variant From CANTAB Connect Research Web-testing.
The Spatial Span reverse test variant from CANTAB connect research web-testing was used calculated by the longest sequence of boxes successfully recalled. Higher score indicates a better outcome. Mean percentage change between pre and post intervention scores was calculated across participants.
Measured: Pre-intervention (Week 1) and Post-intervention (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start18 May 2020
- Primary completion30 Aug 2022
- Study completion1 Oct 2023
Why it stopped: Unable to secure further funding to resume study activities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuryStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Jonathan Evans, PhD, DClin, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882215
- Sponsor's protocol ID
- GN19NE479
- Acronym
- I-PRESS
- Status last verified
- Nov 2023
- First submitted
- 26 Apr 2021
- Last updated
- 14 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.
PubMed 21440699Tornas S, Lovstad M, Solbakk AK, Evans J, Endestad T, Hol PK, Schanke AK, Stubberud J. Rehabilitation of Executive Functions in Patients with Chronic Acquired Brain Injury with Goal Management Training, External Cuing, and Emotional Regulation: A Randomized Controlled Trial. J Int Neuropsychol Soc. 2016 Apr;22(4):436-52. doi: 10.1017/S1355617715001344. Epub 2016 Jan 26.
PubMed 26812574Brehmer Y, Kalpouzos G, Wenger E, Lovden M. Plasticity of brain and cognition in older adults. Psychol Res. 2014 Nov;78(6):790-802. doi: 10.1007/s00426-014-0587-z. Epub 2014 Sep 28.
PubMed 25261907Constantinidis C, Klingberg T. The neuroscience of working memory capacity and training. Nat Rev Neurosci. 2016 Jul;17(7):438-49. doi: 10.1038/nrn.2016.43. Epub 2016 May 26.
PubMed 27225070Klingberg T. Training and plasticity of working memory. Trends Cogn Sci. 2010 Jul;14(7):317-24. doi: 10.1016/j.tics.2010.05.002. Epub 2010 Jun 16.
PubMed 20630350Westerberg H, Klingberg T. Changes in cortical activity after training of working memory--a single-subject analysis. Physiol Behav. 2007 Sep 10;92(1-2):186-92. doi: 10.1016/j.physbeh.2007.05.041. Epub 2007 May 21.
PubMed 17597168Dahlin E, Neely AS, Larsson A, Backman L, Nyberg L. Transfer of learning after updating training mediated by the striatum. Science. 2008 Jun 13;320(5882):1510-2. doi: 10.1126/science.1155466.
PubMed 18556560Dahlin E, Backman L, Neely AS, Nyberg L. Training of the executive component of working memory: subcortical areas mediate transfer effects. Restor Neurol Neurosci. 2009;27(5):405-19. doi: 10.3233/RNN-2009-0492.
PubMed 19847067Jaeggi SM, Buschkuehl M, Jonides J, Perrig WJ. Improving fluid intelligence with training on working memory. Proc Natl Acad Sci U S A. 2008 May 13;105(19):6829-33. doi: 10.1073/pnas.0801268105. Epub 2008 Apr 28.
PubMed 18443283Buschkuehl M, Hernandez-Garcia L, Jaeggi SM, Bernard JA, Jonides J. Neural effects of short-term training on working memory. Cogn Affect Behav Neurosci. 2014 Mar;14(1):147-60. doi: 10.3758/s13415-013-0244-9.
PubMed 24496717Melby-Lervag M, Hulme C. Is working memory training effective? A meta-analytic review. Dev Psychol. 2013 Feb;49(2):270-91. doi: 10.1037/a0028228. Epub 2012 May 21.
PubMed 22612437Hsu NS, Novick JM, Jaeggi SM. The development and malleability of executive control abilities. Front Behav Neurosci. 2014 Jun 24;8:221. doi: 10.3389/fnbeh.2014.00221. eCollection 2014.
PubMed 25071485Jolles DD, Grol MJ, Van Buchem MA, Rombouts SA, Crone EA. Practice effects in the brain: Changes in cerebral activation after working memory practice depend on task demands. Neuroimage. 2010 Aug 15;52(2):658-68. doi: 10.1016/j.neuroimage.2010.04.028. Epub 2010 Apr 23.
PubMed 20399274
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Novel Treatment Intervention for People With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT04882215
- Acronym / sponsor ID
- I-PRESS / GN19NE479
- Conditions
- Acquired Brain Injury
- Keywords
- Traumatic Brain Injury, Stroke, executive dysfunction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to secure further funding to resume study activities.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 18 May 2020 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Posted 14 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a pressing need to develop more effective interventions to remediate cognitive deficits in highly prevalent disabling conditions such as stroke, head injury and other forms of acquired brain injury (ABI). Neuropsychological rehabilitation interventions developed in a clinical setting have shown some beneficial effects, but the effectiveness of clinical interventions have potential to be enhanced if informed by findings from cognitive neuroscience. Research into cognitive training using methods such as functional magnetic resonance imaging (fMRI) has contributed to an understanding of factors that promote changes in brain function, but this approach seldom includes individuals with brain damage or cognitive deficits. Its potential for application with clinical populations is therefore uncertain, meaning that people who may benefit do not have access to interventions that may improve their health and wellbeing.
The proposed research brings together methods from neuropsychological rehabilitation and cognitive neuroscience to investigate 1) the feasibility of, and effect sizes arising from, combining an existing clinical intervention targeting mental strategies with an adaptive training programme targeting core cognitive processes, and 2) whether the novel treatment combination promotes changes in brain function that are detectable using fMRI.
This project will develop and evaluate a training intervention that aims to improve outcomes from a strategy-based rehabilitation intervention, Goal Management Training (GMT), by adding process-based cognitive training with adaptive difficulty to enhance the executive function of working memory updating (WMU). People with ABI (n=32) will complete 9 sessions of GMT, a recommended treatment for deficits in frontal-lobe executive functions, with the addition of 8 WMU training sessions with or without adaptive training. Measures of feasibility, acceptability, and fidelity will be taken, and effect sizes of differences in pre- to post-training changes on neural, cognitive, and functional measurements will be determined by comparing two experimental groups in which difficulty of the WMU training tasks either adaptively increases in response to performance or is fixed.
Detailed description
Globally, stroke and head injury are leading causes of disability. Deficits in cognitive functions are common in these conditions, including impairment in frontal-lobe 'executive' functions such as working memory and the ability to solve problems, plan, and regulate actions in order to achieve intended goals. These deficits affect individuals' ability to live independently, work, and maintain social relationships. We propose that improving outcomes for people with acquired brain injury (ABI) requires an interdisciplinary approach in which neuropsychological rehabilitation and cognitive neuroscience complement one another.
In neuropsychological rehabilitation, interventions are classified as 'restorative' (restoration of underlying core cognitive processes including executive functions) or 'compensatory' (compensation of function through the use of external aids or learned strategies). Clinical guidelines recommend the use of 'meta-cognitive strategy training' for the treatment of deficits in frontal-lobe executive functions. Goal Management Training (GMT) is one such validated meta-cognitive strategy. GMT trains compensatory mental strategies to manage attention during multi-step tasks. GMT has been evaluated behaviourally in randomised controlled trials with positive, albeit modest, outcomes in individuals with ABI.
In cognitive neuroscience, an emerging research area concerns experience-induced neural changes referred to as neural plasticity. These may involve neural changes in: 1) task-based functional activation patterns, i.e. activity increases, decreases, or reorganisation, 2) brain structure, i.e., grey matter and white matter volume changes and 3) functional connectivity, i.e. changes in connectivity between brain regions that are recruited for a mental procedure as well as changes in the strength and magnitude.
Neuroimaging studies have demonstrated that programmes to train core cognitive processes including working memory (WM) executive functions can drive changes both in behavioural and neural measures. Performance gains after process-based training have been observed by several authors employing different training tasks and including both younger and older populations. In addition, generalisation to broad cognitive abilities such as reasoning, episodic memory, after process-based training, has been observed in both young and older adults although this area is under debate. This work has primarily involved healthy adults and whether the same findings apply to those with ABI needs to be investigated.
This research study aims to develop and evaluate a novel treatment intervention for people with ABI that combines a process-based cognitive training with a strategy-based GMT rehabilitation intervention, and to acquire functional magnetic resonance imaging (fMRI) data before and after the intervention to measure patterns of brain activity associated with a task requiring executive functions. We propose that outcomes from GMT might be improved by an adaptive, process-based intervention aimed at enhancing working memory processes. Adaptive task difficulty involves dynamic adjustment of training task demands so that the individual remains within an optimal range of performance.
- Aims
The primary aim of the study is to investigate whether it is feasible and acceptable to deliver a novel intervention combining GMT with WMU training, within a randomised controlled trial (RCT) context in a sample of ABI individuals. A further aim is to examine the behavioural and neural changes related to the novel intervention as well as the effect sizes.
ii. Research Question
This project will combine methods from neuropsychological rehabilitation and cognitive neuroscience to answer the following: 1) Is it feasible to combine an existing treatment for executive dysfunction, GMT, with an adaptive WMU training and how much benefit is gained? 2) Does the novel treatment combination promote neural plasticity that is detectable using fMRI?
iii. Outcomes
Primary outcomes will be measures of feasibility, acceptability, and fidelity.
Secondary outcomes will be pre- to post-training change in behavioural data (i.e., neuro-psychological assessment battery, measures of cognitive task performance and everyday functioning) and fMRI data (i.e., task-related brain activity), analysed by training condition. In addition, exploratory analyses of individual differences in responsiveness to WMU training will be performed, by calculating correlations between amount of adaptive training task improvement and pre- to post-training change on neural, cognitive, and functional measurements.
iv. Design
Randomised controlled trial methodology; specifically stratified randomisation in conjunction with permuted block random allocation, using an active control group will compare two conditions: (1) GMT combined with adaptive training [AT]; (2) GMT combined with non-adaptive [NA] training. Thirty-two adults with non-progressive ABI sustained in adulthood will be recruited from the NHS.. Participants will complete a combination of standard GMT (9 sessions) and 8 WMU (AT or NA) training sessions, delivered in small groups. Neuropsychological and functional assessments will be performed before and after the intervention. In addition, fMRI scanning sessions will be conducted pre- and post-training
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive Training (AT) | Experimental | Behavioral: GMT combined with WMU TrainingFor AT participants, difficulty of the training tasks is progressively increased in response to task performance. |
| Non Adaptive Training (NA) | Active comparator | Behavioral: GMT combined with WMU TrainingFor NA participants, task difficulty is fixed at a relatively low level across all sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Only those able to give informed consent and able to comply with the training protocol will be included.
- ≥ 6 months post-ABI at time of recruitment (expression of interest to participate either verbally or in writing)
- Adults over the age of 18.
- English language fluency (speaking)
- a combination of self/relative/friend/carer reports of everyday organisation/memory problems
Key exclusion criteria (6 listed)
- Individuals with contra-indications to MRI (e.g. heart pacemaker)
- Comorbid progressive neurological disorder or neurodegenerative condition (e.g. dementia)
- Major psychiatric disorder considered likely to prevent engagement in the intervention programme (pre-ABI history of mood disorder or stable antidepressant medication will not lead to exclusion)
- History of major substance abuse problems likely to prevent engagement in the intervention programme
- Unable to give informed consent
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 |
|---|---|---|
| GMT combined with WMU TrainingGMT teaches the use of mental strategies to support sustained attention during complex (multi-step) task performance following an interactive programme. GMT is structured into nine modules, with interactive discussions and homework assignments. It will be conducted on a group basis. WMU training consists of computerised working memory updating tasks in which trial accuracy and response time are recorded. Two tasks will be trained: 1. a visuo-spatial Matrix Updating (MU) and 2. a verbal Keep Track (KT). For both training tasks, level of difficulty can be modulated by increasing or decreasing the update level, i.e., the number of updates on each trial. | Behavioural | Adaptive Training (AT), Non Adaptive Training (NA) |
Primary outcome
Feasibility of Recruitment Process.
Time frame: From pre-intervention (Week 1) to post-intervention (Week 12).
Number of people referred from NHS eligible for screening and those entering the intervention. This will be continuously monitored throughout the study period.
Participants' Drop-out Rates
Time frame: From pre-intervention (Week 1) to post-intervention (Week 12).
Number of people completing the intervention to assess drop-out rates. This will be continuously monitored throughout the study period.
Participants' Coherence and Adherence to the Intervention.
Time frame: From pre-intervention (Week 1) to post-intervention (Week 12).
Mean percentage of working memory training sessions completed (a total of eight) were calculated across participants.
Feedback Questionnaire
Time frame: Post-intervention session (Week 12)
Participant evaluation of the intervention using a study-specific questionnaire including eight 5-point Likert-scale agreement questions (scores of 1 to 5 with 1 being positive and 5 being negative). Mean feedback score was calculated across participants.
8 secondary outcomes
Visuospatial Working Memory Using the Visuospatial Matrix Updating fMRI Task
Time frame: Post-intervention session (week 12)
Visuospatial Working Memory fMRI Task Accuracy Using the Spatial N-back fMRI Task
Time frame: Post-intervention session (Week 12)
Episodic Visual Memory Accuracy Using the Object-location Association fMRI Task.
Time frame: Post-intervention session (Week 12)
Changes in Shifting Attention Using the Intra-Extra Dimensional Set Shift Test Variant From CANTAB Connect Research Web-testing.
Time frame: Pre-intervention (Week 1) and post-intervention (Week 12)
Changes in Spatial Planning and Problem Solving Using the Stockings of Cambridge Test Variant From CANTAB Connect Research Web-testing.
Time frame: Pre-intervention (Week 1) and post-intervention (Week 12)
Changes in Spatial Working Memory Using the Spatial Working Memory Test Variant From CANTAB Connect Research Web-testing.
Time frame: Pre-intervention (Week 1) and post-intervention (Week 12)
Changes in Visuospatial Working Memory Using the Spatial Span Forward Test Variant From CANTAB Connect Research Web-testing.
Time frame: Pre-intervention (Week 1) and post-intervention (Week 12)
Changes in Visuospatial Working Memory Using the Spatial Span Reverse Test Variant From CANTAB Connect Research Web-testing.
Time frame: Pre-intervention (Week 1) and Post-intervention (Week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21440699Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.
- Background: PubMed 26812574Tornas S, Lovstad M, Solbakk AK, Evans J, Endestad T, Hol PK, Schanke AK, Stubberud J. Rehabilitation of Executive Functions in Patients with Chronic Acquired Brain Injury with Goal Management Training, External Cuing, and Emotional Regulation: A Randomized Controlled Trial. J Int Neuropsychol Soc. 2016 Apr;22(4):436-52. doi: 10.1017/S1355617715001344. Epub 2016 Jan 26.
- Background: PubMed 25261907Brehmer Y, Kalpouzos G, Wenger E, Lovden M. Plasticity of brain and cognition in older adults. Psychol Res. 2014 Nov;78(6):790-802. doi: 10.1007/s00426-014-0587-z. Epub 2014 Sep 28.
- Background: PubMed 27225070Constantinidis C, Klingberg T. The neuroscience of working memory capacity and training. Nat Rev Neurosci. 2016 Jul;17(7):438-49. doi: 10.1038/nrn.2016.43. Epub 2016 May 26.
- Background: PubMed 20630350Klingberg T. Training and plasticity of working memory. Trends Cogn Sci. 2010 Jul;14(7):317-24. doi: 10.1016/j.tics.2010.05.002. Epub 2010 Jun 16.
- Background: PubMed 17597168Westerberg H, Klingberg T. Changes in cortical activity after training of working memory--a single-subject analysis. Physiol Behav. 2007 Sep 10;92(1-2):186-92. doi: 10.1016/j.physbeh.2007.05.041. Epub 2007 May 21.
- Background: PubMed 18556560Dahlin E, Neely AS, Larsson A, Backman L, Nyberg L. Transfer of learning after updating training mediated by the striatum. Science. 2008 Jun 13;320(5882):1510-2. doi: 10.1126/science.1155466.
- Background: PubMed 19847067Dahlin E, Backman L, Neely AS, Nyberg L. Training of the executive component of working memory: subcortical areas mediate transfer effects. Restor Neurol Neurosci. 2009;27(5):405-19. doi: 10.3233/RNN-2009-0492.
- Background: PubMed 18443283Jaeggi SM, Buschkuehl M, Jonides J, Perrig WJ. Improving fluid intelligence with training on working memory. Proc Natl Acad Sci U S A. 2008 May 13;105(19):6829-33. doi: 10.1073/pnas.0801268105. Epub 2008 Apr 28.
- Background: PubMed 24496717Buschkuehl M, Hernandez-Garcia L, Jaeggi SM, Bernard JA, Jonides J. Neural effects of short-term training on working memory. Cogn Affect Behav Neurosci. 2014 Mar;14(1):147-60. doi: 10.3758/s13415-013-0244-9.
- Background: PubMed 22612437Melby-Lervag M, Hulme C. Is working memory training effective? A meta-analytic review. Dev Psychol. 2013 Feb;49(2):270-91. doi: 10.1037/a0028228. Epub 2012 May 21.
- Background: PubMed 25071485Hsu NS, Novick JM, Jaeggi SM. The development and malleability of executive control abilities. Front Behav Neurosci. 2014 Jun 24;8:221. doi: 10.3389/fnbeh.2014.00221. eCollection 2014.
- 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.
Jonathan Evans, PhD, DClin principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GMT combined with WMU Training in people with Acquired Brain Injury, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 14 Nov 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 14 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of Recruitment Process. (time frame: From pre-intervention (Week 1) to post-intervention (Week 12).). The study lists 4 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 NCT04882215, which also lists 13 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 14 Nov 2024.