Physiological Responses in Experimentally Induced Cognitive Fatigue in People With Multiple Sclerosis (MS)
PREFIMS
1 other identifier
observational
40
1 country
2
Brief Summary
The current study will add to the current knowledge by combining several electrophysiological techniques to examine the relationship between physiological responses and cognitive fatigue and daily activity performance in a stress- and fatigue-inducing protocol. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2020
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2020
CompletedFirst Submitted
Initial submission to the registry
January 25, 2021
CompletedFirst Posted
Study publicly available on registry
August 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedAugust 12, 2021
August 1, 2021
11 months
January 25, 2021
August 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in heart rate variability (time-domain)
ECG monitoring will be done using the MindMedia NEXUS-10MKII.- Heart Rate Variability will be studied in a time- and frequency domain. For the time-domain following measures are studied: 1) the average normal-normal interval; 2) the standard deviation of normal-normal (SDNN); 3) the Root Mean Square of Successive Differences (RMSSD); 4) the percentage of adjacent normal-normal intervals with differences of more than 50miliseconds. (PNN50).
immediately post protocol (approx. 2 hours after baseline)
Change in heart rate variability (frequency-domain)
ECG monitoring will be done using the MindMedia NEXUS-10MKII.- Heart Rate Variability will be studied in a time- and frequency domain. For the frequency domain, the changes in the high frequency (HF) and low frequency (LF) will be studied and analysed.
immediately post protocol (approx. 2 hours after baseline)
Secondary Outcomes (15)
Change in Visual Analogue Scale (VAS) Momentary fatigue
immediately post protocol (approx. 2 hours after baseline)
Change in Visual Analogue Scale (VAS) Momentary pain
immediately post protocol (approx. 2 hours after baseline)
Usefulness, Satisfaction, and ease of use Questionnaire (USE)
post protocol (approx. 2 hours after baseline)
NASA Task Load Index (NASA-TLX)
post protocol (approx. 2 hours after baseline)
Galvanic Skin Response (GSR)
baseline
- +10 more secondary outcomes
Other Outcomes (4)
Modified Fatigue Impact Scale (MFIS)
baseline
Perceived Stress Scale (PSS)
baseline
Hospital Anxiety and Depression Scale (HADS)
baseline
- +1 more other outcomes
Study Arms (2)
Multiple Sclerosis (MS)
People with MS diagnosis, aged 18-55 years, Relapsing Remitting type, EDSS \< 6.0, normal vision (if necessary corrected), Dutch speaking.
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.
Interventions
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
A convenience sample of 20 people with currently stable multiple sclerosis (MS) between 18 and 55 years old and able to walk for 100m will be recruited from the National MS Center Melsbroek, as well as 20 age-matched healthy volunteers.
You may qualify if:
- diagnosis MS, Relapsing Remitting (RR) type (MS group)
- Expanded Disability Status Scale (EDSS) \<6 (MS group)
- Dutch speaking
- normal or corrected vision
- feasible use of computer
You may not qualify if:
- relapse \< 3 months (MS group)
- pregnancy
- relevant comorbidity (thyroid disease, diabetes, other neurological disorders, metabolic diseases, neuro-endocrine tumor(s)
- severe cognitive disability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
- National MS Center Melsbroekcollaborator
Study Sites (2)
KU Leuven, Department of Rehabilitation Sciences
Leuven, 3000, Belgium
National Multiple Sclerosis Center
Melsbroek, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daphne Kos, PhD
KU Leuven
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 25, 2021
First Posted
August 12, 2021
Study Start
October 15, 2020
Primary Completion
August 30, 2021
Study Completion
September 1, 2021
Last Updated
August 12, 2021
Record last verified: 2021-08