NCT05003375|Unknown
Physiological Responses in Experimentally Induced Cognitive Fatigue in People With Multiple Sclerosis (MS)
PREFIMS
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PREFIMS
Sponsor study identifier
observational
40
1 country
2
Study Start
October 15, 2020
Actual (reported)Primary Completion
August 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2020
Actual (reported)January 25, 2021
Actual (reported)August 12, 2021
Actual (reported)August 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
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
Modified Fatigue Impact Scale (MFIS)
baseline
Perceived Stress Scale (PSS)
baseline
Hospital Anxiety and Depression Scale (HADS)
baseline
People with MS diagnosis, aged 18-55 years, Relapsing Remitting type, EDSS \< 6.0, normal vision (if necessary corrected), Dutch speaking.
Healthy controls without relevant health conditions (diabetes, thyroid diseases, neurological disorders), non-pregnant, aged 18-55 years, normal vision (if necessary corrected), Dutch speaking.
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
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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.
KU Leuven, Department of Rehabilitation Sciences
Leuven, 3000, Belgium
National Multiple Sclerosis Center
Melsbroek, Belgium
Daphne Kos, PhD
KU Leuven
First Submitted
January 25, 2021
First Posted
August 12, 2021
Study Start
October 15, 2020
Actual (reported)Primary Completion
August 30, 2021
Estimated (date passed)Bright Light Therapy as Possible Treatment Option for MS-Fatigue
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 12, 2021
Record last verified: 2021-08
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