StrokeMenFASNCT04866420
Understanding Mental Fatigue After Stroke
An observational study of Stroke and Post-Stroke Fatigue, run by Oxford Brookes University at 1 site in United Kingdom.
Trial summary
Mental fatigue is a major problem for stroke survivors and sometimes remains present years after the event. It is often rated as the most persisting and frustrating symptom. For many, mental fatigue has a significant negative effect on rehabilitation, and patients report difficulties with returning to previous levels… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Post-Stroke Fatigue, Fatigue
- What is being tested?
- The MenFAS Study
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 May 2021to 5 Dec 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be > 2 months post stroke and will be in this study for a maximum 4 week period, consisting of two sessions at home.
Who may be able to join
- Clinical diagnosis of stroke
- Are over the age of 18 (no upper limit)
- Ability to understand spoken and / or written English
Who cannot join
- Not functionally able to undergo neuropsychological assessment or reply to questionnaires. This will be assessed on the cognitive screen, the Oxford Cognitive Screen (OCS).
- Medically unstable or have another condition that could impact results (e.g. substance abuse).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Health and Life Sciences
Oxford, Oxfordshire, OX30PB
About this study
Official title: The MenFAS Study: Understanding Mental Fatigue After Stroke
Mental fatigue is a major problem for stroke survivors and sometimes remains present years after the event. It is often rated as the most persisting and frustrating symptom. For many, mental fatigue has a significant negative effect on rehabilitation, and patients report difficulties with returning to previous levels of participation in their meaningful everyday activities whether at home, work or in the community.
The development of effective evidence based interventions have been limited by our understanding of post stroke fatigue. This may be attributed to the fact that the underlying mechanisms for post stroke mental fatigue are unknown. Evolving theories suggest that mental fatigue may be associated with a dysfunction in the cognitive domain of attention.
Read more
An impairment in the domain of attention may result in previously effortless activities of daily living that require sustained attention to become exhausting. Specific knowledge on the influence of background noise and other distractions on a person's ability to sustain attention after stroke is lacking. This research project will contribute to new and important knowledge in this area.
A total of 30 adults will be reviewed at least 2 months after stroke on tasks that require sustained attention. The investigators plan to observe the influence background distraction has on the ability to do these tasks and whether wearing earphones will assist with concentration levels, and reduce fatiguing situations.
This project provides a unique opportunity to investigate how a dysfunction in the cognitive domain of attention may be related to the experience of mental fatigue after stroke. The investigators will use a reaction time based test, fatigue questionnaires, alongside the wearing of earphones when examining associations. This knowledge may help to determine who is at risk of developing symptoms of mental fatigue. Furthermore, it may shed a light on possible prevention strategies, and provide more suitable guidance to those affected by mental fatigue.
Read the detailed description
Fatigue is reported by stroke survivors as a highly problematic and persisting experience with many rating it as their most severe amongst all post - stroke sequelae. Given the negative impact of fatigue on participation, an investigation into the possible underlying mechanisms mediating fatigue after stroke has clinical implications.
Recent studies indicate that an impairment in the domain of attention is related to the experience of higher fatigue levels. However, the complexity of this mechanism, presentation and measurement have made the findings unclear. In studies, testing methods to identify a dysfunction in the domain of attention can be mentally fatiguing. Moreover, it is not clear whether the impact of contextual factors on concentration levels, such as background noise and distraction, has been considered.
Primary Objective:
Among people with stroke engaging in a task requiring sustained attention, to what extent does the use of noise-cancelling earphones impact on mental fatigue? Fatigue will be assessed using two measures: 1) The Continuous Performance Test, a reaction time based assessment completed on a computer tablet and 2) A Visual Analog Scale for Fatigue, which is paper based.
Design: A cross - over repeated exposure randomised design will be used. Study participants will be randomised to do tasks of sustained attention, followed by a reaction time based assessment on a tablet, first with and then without earphones or first without and then with earphones. The two assessment sessions will be done one week apart to allow for a washout period. Participants will be invited to rank their fatigue levels on a visual analog scale, pre - post these assessments.
Secondary Objectives:
- Is baseline cognitive fatigue a predictor for performance decrement on tasks of sustained attention? This will be assessed using the Fatigue Scale for Motor and Cognitive Functions (FSMC). This scale includes both physical and cognitive aspects of fatigue.
- What are the contextual factors mediating fatigue symptoms? This will be assessed using a momentary ecological assessment application on a mobile phone or a diary paper based assessment.
- What is the influence of fatigue symptoms on participatory patterns as seen on the ecological momentary app or diary? This will be assessed with a wrist worn Accelerometer.
- Conditions
- Stroke, Post-Stroke Fatigue, Fatigue
- Being tested
- The MenFAS Study
- Keywords
- Cognitive impairment, Attention
- Medical subject headings
- Stroke, Fatigue, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The MenFAS StudyBehavioural
A cross over repeated exposure randomized design observational study
| Study group | Role | What they receive |
|---|---|---|
| Poststroke fatigue | Participants who are experiencing fatigue post stroke. Receives: Behavioral: The MenFAS Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Continuous Performance Task
The Continuous Performance Task (CPT) is a computerised reaction time test and is one of the most frequently used, objective tools to measure sustained attention over time. This assessment takes 12 minutes. Sustained attention will be assessed based on changes on performance over time. The task will be completed twice (once with, once without earphones) over the two assessment days.
Measured: 12 minutes
Change in baseline fatigue at 2 hours - Visual Analog Scale for fatigue
A VAS consisting of a 10cm vertical line from 1 (no fatigue) to 10 (worst possible fatigue) will be used to obtain the momentary fatigue associated with completing the task of sustained attention. Participants will rank their mental fatigue at the beginning and the end of each reaction time task (on the CPT) performed.
Measured: 4 x across 2 testing days (1 week apart). Day 1: Before (baseline) and after reaction time assessment (2hours). Day 2: Before (baseline) and after reaction time assessment (2hours)
Secondary outcomes (3)
Fatigue Scale for Motor and Cognitive functions.
Baseline fatigue will be measured using the self-reported Fatigue Scale for Motor and Cognitive Functions (FSMC) which has been validated for use in neurological conditions, including stroke (Ref -Hubs). This scale includes both physical and cognitive fatigue. Cut-off values for the FSMC total scale and both subscales were determined by standard deviations from the mean values of healthy control population in two other studies (Hubacher et al 2012; Penner et al 2009). Subdivision from mild, moderate to severe fatigue for both domains as well as for the composite fatigue score are provided:
FSMC Sum Score ≥43 Mild fatigue, ≥53 Moderate fatigue, ≥63 Severe fatigue. FSMC Cognitive Score ≥22 Mild cognitive fatigue ≥ 28 Moderate cognitive fatigue ≥ 34 Severe cognitive fatigue FSMC Physical Score ≥ 22 Mild motor fatigue, ≥27 Moderate motor fatigue, ≥32 Severe motor fatigue.
Measured: Baseline fatigue.
Oxford Cognitive Screen
Baseline cognitive abilities will be assessed using the Oxford Cognitive Screen (OCS). The OCS assesses the major cognitive domains of memory, language, number, praxis, executive functions and attention. It has been designed as a screening tool which provides a rapid assessment (approximately 15 minutes) of a patient's cognitive function. The OCS is inclusive for patients with aphasia and neglect.
Measured: Baseline cognitive abilities
Ecological Momentary Assessment App
This study will use a smart ecological momentary assessment delivered via a smart - phone app (smart EMA). The smart EMA samples in -the- moment data of fatigue and activity. Participants record fatigue levels (on a VAS) and contextual factors alongside every day and meaningful occupational participation from pre-defined lists. The app was developed using an iterative, user centred design and is grounded in the fatigue experiences of people with acquired brain injury, including stroke. It has been tested on participants with brain injury in the community and received good response and completion rates, with high levels of satisfaction. The participant will be prompted five times a day to record their activity and fatigue levels over a seven day period.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start3 May 2021
- Primary completion5 Dec 2021
- Study completion5 Dec 2021
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 StrokeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Brookes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avril Dillon, Oxford Brookes University
- Investigators
- Avril Dillon, BSc, Principal investigator, Oxford Brookes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866420
- Sponsor's protocol ID
- 201376
- Acronym
- MenFAS
- Status last verified
- Apr 2022
- First submitted
- 22 Apr 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hubacher M, Calabrese P, Bassetti C, Carota A, Stocklin M, Penner IK. Assessment of post-stroke fatigue: the fatigue scale for motor and cognitive functions. Eur Neurol. 2012;67(6):377-84. doi: 10.1159/000336736. Epub 2012 May 17.
PubMed 22614741Penner IK, Raselli C, Stocklin M, Opwis K, Kappos L, Calabrese P. The Fatigue Scale for Motor and Cognitive Functions (FSMC): validation of a new instrument to assess multiple sclerosis-related fatigue. Mult Scler. 2009 Dec;15(12):1509-17. doi: 10.1177/1352458509348519. Epub 2009 Dec 7.
PubMed 19995840
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MenFAS Study: Understanding Mental Fatigue After Stroke
- ClinicalTrials.gov ID
- NCT04866420
- Acronym / sponsor ID
- MenFAS / 201376
- Conditions
- Stroke, Post-Stroke Fatigue, Fatigue
- Keywords
- Cognitive impairment, Attention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Oxford Brookes UniversityUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 5 Dec 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 29 Apr 2021 (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.
Mental fatigue is a major problem for stroke survivors and sometimes remains present years after the event. It is often rated as the most persisting and frustrating symptom. For many, mental fatigue has a significant negative effect on rehabilitation, and patients report difficulties with returning to previous levels of participation in their meaningful everyday activities whether at home, work or in the community.
The development of effective evidence based interventions have been limited by our understanding of post stroke fatigue. This may be attributed to the fact that the underlying mechanisms for post stroke mental fatigue are unknown. Evolving theories suggest that mental fatigue may be associated with a dysfunction in the cognitive domain of attention.
An impairment in the domain of attention may result in previously effortless activities of daily living that require sustained attention to become exhausting. Specific knowledge on the influence of background noise and other distractions on a person's ability to sustain attention after stroke is lacking. This research project will contribute to new and important knowledge in this area.
A total of 30 adults will be reviewed at least 2 months after stroke on tasks that require sustained attention. The investigators plan to observe the influence background distraction has on the ability to do these tasks and whether wearing earphones will assist with concentration levels, and reduce fatiguing situations.
This project provides a unique opportunity to investigate how a dysfunction in the cognitive domain of attention may be related to the experience of mental fatigue after stroke. The investigators will use a reaction time based test, fatigue questionnaires, alongside the wearing of earphones when examining associations. This knowledge may help to determine who is at risk of developing symptoms of mental fatigue. Furthermore, it may shed a light on possible prevention strategies, and provide more suitable guidance to those affected by mental fatigue.
Detailed description
Fatigue is reported by stroke survivors as a highly problematic and persisting experience with many rating it as their most severe amongst all post - stroke sequelae. Given the negative impact of fatigue on participation, an investigation into the possible underlying mechanisms mediating fatigue after stroke has clinical implications.
Recent studies indicate that an impairment in the domain of attention is related to the experience of higher fatigue levels. However, the complexity of this mechanism, presentation and measurement have made the findings unclear. In studies, testing methods to identify a dysfunction in the domain of attention can be mentally fatiguing. Moreover, it is not clear whether the impact of contextual factors on concentration levels, such as background noise and distraction, has been considered.
Primary Objective:
Among people with stroke engaging in a task requiring sustained attention, to what extent does the use of noise-cancelling earphones impact on mental fatigue? Fatigue will be assessed using two measures: 1) The Continuous Performance Test, a reaction time based assessment completed on a computer tablet and 2) A Visual Analog Scale for Fatigue, which is paper based.
Design: A cross - over repeated exposure randomised design will be used. Study participants will be randomised to do tasks of sustained attention, followed by a reaction time based assessment on a tablet, first with and then without earphones or first without and then with earphones. The two assessment sessions will be done one week apart to allow for a washout period. Participants will be invited to rank their fatigue levels on a visual analog scale, pre - post these assessments.
Secondary Objectives:
- Is baseline cognitive fatigue a predictor for performance decrement on tasks of sustained attention? This will be assessed using the Fatigue Scale for Motor and Cognitive Functions (FSMC). This scale includes both physical and cognitive aspects of fatigue.
- What are the contextual factors mediating fatigue symptoms? This will be assessed using a momentary ecological assessment application on a mobile phone or a diary paper based assessment.
- What is the influence of fatigue symptoms on participatory patterns as seen on the ecological momentary app or diary? This will be assessed with a wrist worn Accelerometer.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Poststroke fatigue | – | Behavioral: The MenFAS StudyParticipants who are experiencing fatigue post stroke. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be > 2 months post stroke and will be in this study for a maximum 4 week period, consisting of two sessions at home.
Key inclusion criteria (3 listed)
- Clinical diagnosis of stroke
- Are over the age of 18 (no upper limit)
- Ability to understand spoken and / or written English
Key exclusion criteria (2 listed)
- Not functionally able to undergo neuropsychological assessment or reply to questionnaires. This will be assessed on the cognitive screen, the Oxford Cognitive Screen (OCS).
- Medically unstable or have another condition that could impact results (e.g. substance abuse).
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 |
|---|---|---|
| The MenFAS StudyA cross over repeated exposure randomized design observational study | Behavioural | Poststroke fatigue |
Primary outcome
The Continuous Performance Task
Time frame: 12 minutes
The Continuous Performance Task (CPT) is a computerised reaction time test and is one of the most frequently used, objective tools to measure sustained attention over time. This assessment takes 12 minutes. Sustained attention will be assessed based on changes on performance over time. The task will be completed twice (once with, once without earphones) over the two assessment days.
Change in baseline fatigue at 2 hours - Visual Analog Scale for fatigue
Time frame: 4 x across 2 testing days (1 week apart). Day 1: Before (baseline) and after reaction time assessment (2hours). Day 2: Before (baseline) and after reaction time assessment (2hours)
A VAS consisting of a 10cm vertical line from 1 (no fatigue) to 10 (worst possible fatigue) will be used to obtain the momentary fatigue associated with completing the task of sustained attention. Participants will rank their mental fatigue at the beginning and the end of each reaction time task (on the CPT) performed.
3 secondary outcomes
Fatigue Scale for Motor and Cognitive functions.
Time frame: Baseline fatigue.
Oxford Cognitive Screen
Time frame: Baseline cognitive abilities
Ecological Momentary Assessment App
Time frame: 7 days
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 7 Apr 2022.
- Background: PubMed 22614741Hubacher M, Calabrese P, Bassetti C, Carota A, Stocklin M, Penner IK. Assessment of post-stroke fatigue: the fatigue scale for motor and cognitive functions. Eur Neurol. 2012;67(6):377-84. doi: 10.1159/000336736. Epub 2012 May 17.
- Background: PubMed 19995840Penner IK, Raselli C, Stocklin M, Opwis K, Kappos L, Calabrese P. The Fatigue Scale for Motor and Cognitive Functions (FSMC): validation of a new instrument to assess multiple sclerosis-related fatigue. Mult Scler. 2009 Dec;15(12):1509-17. doi: 10.1177/1352458509348519. Epub 2009 Dec 7.
- Individual participant dataSharing planned: Undecided
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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.
Avril Dillon, BSc principal investigator
Oxford Brookes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Post-Stroke Fatigue, run by Oxford Brookes University 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 3 inclusion and 2 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 7 Apr 2022. 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?
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?
The Continuous Performance Task (time frame: 12 minutes). The study lists 2 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 NCT04866420, 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 7 Apr 2022; AzTrials last refreshed its copy on 29 Oct 2026.