Physiological Responses in Experimentally Induced Cognitive Fatigue in People With Multiple Sclerosis (MS)
NCT ID: NCT05003375
Last Updated: 2021-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2020-10-15
2021-09-01
Brief Summary
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The aims of this study are: 1) to evaluate the feasibility and usability of assessing physiological responses in an experimental set-up and 2) to investigate the association between physiological outcomes, experimentally induced stress and cognitive fatigue in people with multiple sclerosis (MS) and healthy controls.
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Detailed Description
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Physiological responses (heart rate variability, skin conductance, body temperature) and brain activity (EEG) will be measured while resting (resting baseline), while speaking as normal (speaking baseline), during protocol performance and following the protocol (post-protocol).
Demographic and clinical characteristics, as well as levels of perceived fatigue, stress, pain, daily activity performance, quality of life and anxiety and depression will be assessed using medical records and questionnaires.
Feasibility and usability will be assessed in participants and researcher(s) by standardized questionnaires.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Multiple Sclerosis (MS)
People with MS diagnosis, aged 18-55 years, Relapsing Remitting type, EDSS \< 6.0, normal vision (if necessary corrected), Dutch speaking.
High-challenging cognitive protocol to provoke stress and (cognitive) fatigue
Baseline measurement is done in two parts: 1) resting for five minutes (no talking, no movement) and 2) speaking at normal pace (2 minutes).
This is immediately followed by a measurement of the physiological response variables during the testing, in which the following protocol is performed in the order presented: 1) SDMT-NBack task-SDMT\*-NBacktask\*\*, 2) NBack task-SDMT-NBack task-SDMT. Participants will run either sequence to check for effects of the previous testing. During the conduct of the study, it will be ensured that half of the participants in each group followed Sequence 1 and the other half of the group followed Sequence 2.
During all these measurements, the participant will sit at a table with a computer on which the tests are performed.
\*SDMT: Symbol Digit Modalities Test: see description in outcome measures
\*\*N-Back Task: see description in outcome measures
Healthy Controls (HC)
Healthy controls without relevant health conditions (diabetes, thyroid diseases, neurological disorders), non-pregnant, aged 18-55 years, normal vision (if necessary corrected), Dutch speaking.
High-challenging cognitive protocol to provoke stress and (cognitive) fatigue
Baseline measurement is done in two parts: 1) resting for five minutes (no talking, no movement) and 2) speaking at normal pace (2 minutes).
This is immediately followed by a measurement of the physiological response variables during the testing, in which the following protocol is performed in the order presented: 1) SDMT-NBack task-SDMT\*-NBacktask\*\*, 2) NBack task-SDMT-NBack task-SDMT. Participants will run either sequence to check for effects of the previous testing. During the conduct of the study, it will be ensured that half of the participants in each group followed Sequence 1 and the other half of the group followed Sequence 2.
During all these measurements, the participant will sit at a table with a computer on which the tests are performed.
\*SDMT: Symbol Digit Modalities Test: see description in outcome measures
\*\*N-Back Task: see description in outcome measures
Interventions
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High-challenging cognitive protocol to provoke stress and (cognitive) fatigue
Baseline measurement is done in two parts: 1) resting for five minutes (no talking, no movement) and 2) speaking at normal pace (2 minutes).
This is immediately followed by a measurement of the physiological response variables during the testing, in which the following protocol is performed in the order presented: 1) SDMT-NBack task-SDMT\*-NBacktask\*\*, 2) NBack task-SDMT-NBack task-SDMT. Participants will run either sequence to check for effects of the previous testing. During the conduct of the study, it will be ensured that half of the participants in each group followed Sequence 1 and the other half of the group followed Sequence 2.
During all these measurements, the participant will sit at a table with a computer on which the tests are performed.
\*SDMT: Symbol Digit Modalities Test: see description in outcome measures
\*\*N-Back Task: see description in outcome measures
Eligibility Criteria
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Inclusion Criteria
* Expanded Disability Status Scale (EDSS) \<6 (MS group)
* Dutch speaking
* normal or corrected vision
* feasible use of computer
Exclusion Criteria
* pregnancy
* relevant comorbidity (thyroid disease, diabetes, other neurological disorders, metabolic diseases, neuro-endocrine tumor(s)
* severe cognitive disability
18 Years
55 Years
ALL
Yes
Sponsors
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National MS Center Melsbroek
OTHER
KU Leuven
OTHER
Responsible Party
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Daphne Kos
Associate Professor
Principal Investigators
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Daphne Kos, PhD
Role: PRINCIPAL_INVESTIGATOR
KU Leuven
Locations
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KU Leuven, Department of Rehabilitation Sciences
Leuven, , Belgium
National Multiple Sclerosis Center
Melsbroek, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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S63552
Identifier Type: -
Identifier Source: org_study_id
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