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| Name | Class |
|---|---|
| National MS Center Melsbroek | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-challenging cognitive protocol to provoke stress and (cognitive) fatigue | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analogue Scale (VAS) Momentary fatigue | Momentary fatigue experienced following the protocol using Visual Analogue Scale (VAS) (minimum 0- maximum 10), higher scores indicate higher fatigue. | immediately post protocol (approx. 2 hours after baseline) |
| Change in Visual Analogue Scale (VAS) Momentary pain |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Fatigue Impact Scale (MFIS) | The MFIS is a self-report questionnaire used to measure the perceived impact of fatigue on physical, cognitive and psychosocial functioning. The participant answers 21 items on the basis of a 5-point Likert scale (0 = never; 5 = almost always). A higher score on the subscales (physical dimension: 0-36; cognitive dimension: 0-40; psychosocial functioning: 0-8) or in the total score represents a higher degree of fatigue. |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daphne Kos, PhD | Contact | +32496-107849 | daphne.kos@kuleuven.be | |
| Niels Peeters, MSc | Contact | +32474296463 | daphne.kos@kuleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Daphne Kos, PhD | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KU Leuven, Department of Rehabilitation Sciences | Recruiting | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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|
Momentary pain experienced following the protocol using Visual Analogue Scale (minimum 0- maximum 10), higher scores indicate higher pain. |
| immediately post protocol (approx. 2 hours after baseline) |
| Usefulness, Satisfaction, and ease of use Questionnaire (USE) | The USE is a self-report questionnaire in which 30 items in four dimensions (usefulness, ease of use, ease of learning and satisfaction) are answered on a 7-point Likert scale (1 = disagree, 7 = fully agree) and one not -answer option. Higher scores indicate higher satisfaction and usefulness. | post protocol (approx. 2 hours after baseline) |
| NASA Task Load Index (NASA-TLX) | The NASA-TLX is a self-report questionnaire that measures perceived work-related stress using six dimensions with a focus on mental stress: mental, physical and time-related stress, frustration and execution. The dimensions are assessed on the basis of a semantic differential scale (0-10). The six individual scores are converted to a global score by means of a "paired comparison task" in which "comparison cards" are used prior to the assessment. Higher scores indicate higher task load. | post protocol (approx. 2 hours after baseline) |
| Galvanic Skin Response (GSR) |
| baseline |
| Galvanic Skin Response (GSR) |
| during protocol (approx. 1 hour after baseline) |
| Galvanic Skin Response (GSR) |
| immediately post protocol (approx. 2 hours after baseline) |
| Brain activity | • Electroencephalography (EEG):
EEG measures: - The impact of the cognitive fatigue and stress inducing protocol on alpha, beta, delta, and there frequency bands will be studied. | baseline |
| Brain activity | • Electroencephalography (EEG):
EEG measures: - The impact of the cognitive fatigue and stress inducing protocol on alpha, beta, delta, and there frequency bands will be studied. | during protocol (approx. 1 hour after baseline) |
| Brain activity | • Electroencephalography (EEG):
EEG measures: - The impact of the cognitive fatigue and stress inducing protocol on alpha, beta, delta, and there frequency bands will be studied. | immediately post protocol (approx. 2 hours after baseline) |
| Respiration | Respiration set up:
Respiration measures:
| baseline |
| Respiration | Respiration set up:
Respiration measures:
| during protocol (approx. 1 hour after baseline) |
| Respiration | Respiration set up:
Respiration measures:
| immediately post protocol (approx. 2 hours after baseline) |
| Decline in Symbol Digit Modalities Test | The Symbol Digit Modalities Test (SDMT) Performance
Scores
| immediately post protocol (approx. 2 hours after baseline) |
| Decline in N-Back Task | The N-Back Task (NBT) Performance:
Scores:
| immediately post protocol (approx. 2 hours after baseline) |
| baseline |
| Perceived Stress Scale (PSS) | Questionnaire on perceived stress in daily life (14 items) The Perceived Stress Scale (PSS) is a self-report questionnaire to measure the perceived stress. In 14 items perceived stress is judged by taking into account the previous month's experiences.. Scoring is done using a 5-point Likert scale (0 = never; 4 = very often), with a maximum score (56) representing a higher degree of perceived stress. | baseline |
| Hospital Anxiety and Depression Scale (HADS) | Self-report questionnaire of depression and anxiety (14 items) The HADS is aimed at assessing anxiety and depression in a non-psychiatric setting, without questioning physical complaints such as fatigue.The HADS is a self-report questionnaire of 14 items that are answered on the basis of an ordinal scale with four answer options (0-3). Depression and anxiety subscale scores range from 0-21, with higher scores indicating increased depression or anxiety, respectively. | baseline |
| Life Balance Inventory (LBI) | LBI is a self-report assessment instrument containing 53 activities and on a dichotomous scale of yes/no, people have to answer, whether or not they do the activity or want to do the activity. For each item scored 'yes', participants have to rate their satisfaction with the amount of time they have spent doing that activity in the past month compared to the amount of time they wanted to do the activity. The possible answers are: "always less than I want (1), sometimes less than I want (2), about right for me (3), sometimes more than I want (2), always more than I want (1)". The LBI contains four subscales: (1) Health subscale (ex. Relaxing, getting regular exercise, …), (2) Relationship subscale (ex. Doing things with friends, partner, …), (3) Identity subscale (ex. Taking care of your appearance, participating in religious events, …), (4) Challenge/interest subscale (ex. Working for pay, making music, …). Higher scores reflect better life balance. | baseline |
| National Multiple Sclerosis Center | Recruiting | Melsbroek | Belgium |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |