Understanding Mental Fatigue After Stroke

NCT04866420 | Completed DMC

• 1 other identifier: 201376
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Stroke; Post-Stroke Fatigue; Fatigue

Keywords

Cognitive impairment; Attention

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

• Oxford Cognitive Screen

  Baseline cognitive abilities

• Ecological Momentary Assessment App

  7 days

Other Outcomes (1)

• Accelerometer

  7 days

Study Arms (1)

Poststroke fatigue

Participants who are experiencing fatigue post stroke.

Behavioral: The MenFAS Study

Interventions

The MenFAS Study BEHAVIORAL

A cross over repeated exposure randomized design observational study

Poststroke fatigue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Clinical diagnosis of stroke
• Are over the age of 18 (no upper limit)
• Ability to understand spoken and / or written English

You may not qualify if:

• 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).

Sponsors & Collaborators

• Oxford Brookes University: lead

Study Sites (1)

Health and Life Sciences

Oxford, Oxfordshire, OX30PB, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 22614741 BACKGROUND

• Penner 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.

  PMID: 19995840 BACKGROUND

MeSH Terms

Conditions

Stroke; Fatigue; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Avril Dillon, BSc

  Oxford Brookes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Elizabeth Casson Trust PhD Scholar

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 29, 2021
• Study Start: May 3, 2021
• Primary Completion: December 5, 2021
• Study Completion: December 5, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

GB (1)