Clinical trial NCT05003375: Physiological Responses in Experimentally Induced Cognitive Fatigue in People With Multiple Sclerosis (MS)
Official title: Physiological Responses in Experimentally Induced Cognitive Fatigue in People With Multiple Sclerosis (MS): a Feasibility Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Fatigue
Stress
Keywords: fatigability
cognitive fatigue
cognitive fatigability
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: National MS Center Melsbroek
First posted: 2021-08-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: In an experimental set-up participants (20 people with MS and 20 healthy controls) will perform a high-challenging cognitive protocol to provoke stress and (cognitive) fatigue.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* relapse \< 3 months (MS group)
* pregnancy
* relevant comorbidity (thyroid disease, diabetes, other neurological disorders, metabolic diseases, neuro-endocrine tumor(s)
* severe cognitive disability

Primary outcomes:
measure: Change in heart rate variability (time-domain)
timeFrame: immediately post protocol (approx. 2 hours after baseline)
measure: Change in heart rate variability (frequency-domain)
timeFrame: immediately post protocol (approx. 2 hours after baseline)
Secondary outcomes:
measure: Change in Visual Analogue Scale (VAS) Momentary fatigue
timeFrame: immediately post protocol (approx. 2 hours after baseline)
measure: Change in Visual Analogue Scale (VAS) Momentary pain
timeFrame: immediately post protocol (approx. 2 hours after baseline)
measure: Usefulness, Satisfaction, and ease of use Questionnaire (USE)
timeFrame: post protocol (approx. 2 hours after baseline)
measure: NASA Task Load Index (NASA-TLX)
timeFrame: post protocol (approx. 2 hours after baseline)
measure: Galvanic Skin Response (GSR)
timeFrame: baseline
measure: Galvanic Skin Response (GSR)
timeFrame: during protocol (approx. 1 hour after baseline)
measure: Galvanic Skin Response (GSR)
timeFrame: immediately post protocol (approx. 2 hours after baseline)
measure: Brain activity
timeFrame: baseline
measure: Brain activity
timeFrame: during protocol (approx. 1 hour after baseline)
measure: Brain activity
timeFrame: immediately post protocol (approx. 2 hours after baseline)
measure: Respiration
timeFrame: baseline
measure: Respiration
timeFrame: during protocol (approx. 1 hour after baseline)
measure: Respiration
timeFrame: immediately post protocol (approx. 2 hours after baseline)
measure: Decline in Symbol Digit Modalities Test
timeFrame: immediately post protocol (approx. 2 hours after baseline)
measure: Decline in N-Back Task
timeFrame: immediately post protocol (approx. 2 hours after baseline)
Other outcomes:
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: baseline
measure: Perceived Stress Scale (PSS)
timeFrame: baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline
measure: Life Balance Inventory (LBI)
timeFrame: baseline
Locations:
city: Leuven
country: Belgium
facility: KU Leuven, Department of Rehabilitation Sciences
city: Melsbroek
country: Belgium
facility: National Multiple Sclerosis Center
Study officials:
affiliation: KU Leuven
name: Daphne Kos, PhD
role: PRINCIPAL_INVESTIGATOR
References: