Multiple SclerosisPREFIMSNCT05003375
Physiological Responses in Experimentally Induced Cognitive Fatigue in People With Multiple Sclerosis (MS)
An observational study of Multiple Sclerosis and Fatigue, run by KU Leuven at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Fatigue, Stress
- What is being tested?
- High-challenging cognitive protocol to provoke stress and (cognitive) fatigue
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 2 sitesBelgium
- Study dates
- 15 Oct 2020to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- relapse < 3 months (MS group)
- pregnancy
- relevant comorbidity (thyroid disease, diabetes, other neurological disorders, metabolic diseases, neuro-endocrine tumor(s)
- severe cognitive disability
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
KU Leuven, Department of Rehabilitation Sciences
Leuven, 3000
Daphne Kos, PhD, daphne.kos@kuleuven.be
Niels Peeters, MSc, niels.peeters@kuleuven.be
- Recruiting
National Multiple Sclerosis Center
Melsbroek
Sofie Ferdinand, Ba, +3225978690, sofie.ferdinand@mscenter.be
Mieke D'hooge, MSc, mieke.dhooge@mscenter.be
About this study
Official title: Physiological Responses in Experimentally Induced Cognitive Fatigue in People With Multiple Sclerosis (MS): a Feasibility Study
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Fatigue, Stress
- Being tested
- High-challenging cognitive protocol to provoke stress and (cognitive) fatigue
- Keywords
- fatigability, cognitive fatigue, cognitive fatigability
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-challenging cognitive protocol to provoke stress and (cognitive) fatigueBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis (MS) | People with MS diagnosis, aged 18-55 years, Relapsing Remitting type, EDSS < 6.0, normal vision (if necessary corrected), Dutch speaking. Receives: Behavioral: High-challenging cognitive protocol to provoke stress and (cognitive) fatigue | |
| 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. Receives: Behavioral: High-challenging cognitive protocol to provoke stress and (cognitive) fatigue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: immediately post protocol (approx. 2 hours after baseline)
Secondary outcomes (15)
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.
Measured: immediately post protocol (approx. 2 hours after baseline)
Change in Visual Analogue Scale (VAS) Momentary pain
Momentary pain experienced following the protocol using Visual Analogue Scale (minimum 0- maximum 10), higher scores indicate higher pain.
Measured: 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.
Measured: 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.
Measured: post protocol (approx. 2 hours after baseline)
Galvanic Skin Response (GSR)
- For the monitoring of the GSR, the Mind Media NEXUS-10MKII will be used.
- Two electrodes will be placed on the palmar side of the left manus. The first electrode is positioned on the phalanx medialis of the index, the second electrode is positioned on the phalanx medialis of the digitus annulare.
- As the participants will not be exposed to abrupt changes in stimulus presentation, and no expected or unexpected changes in the environment will be present, the tonic Skin Conductance Level (SCL) will be analysed.
Measured: baseline
Galvanic Skin Response (GSR)
- For the monitoring of the GSR, the Mind Media NEXUS-10MKII will be used.
- Two electrodes will be placed on the palmar side of the left manus. The first electrode is positioned on the phalanx medialis of the index, the second electrode is positioned on the phalanx medialis of the digitus annulare.
- As the participants will not be exposed to abrupt changes in stimulus presentation, and no expected or unexpected changes in the environment will be present, the tonic Skin Conductance Level (SCL) will be analysed, using mean microsiemens.
Measured: during protocol (approx. 1 hour after baseline)
Galvanic Skin Response (GSR)
- For the monitoring of the GSR, the Mind Media NEXUS-10MKII will be used.
- Two electrodes will be placed on the palmar side of the left manus. The first electrode is positioned on the phalanx medialis of the index, the second electrode is positioned on the phalanx medialis of the digitus annulare.
- As the participants will not be exposed to abrupt changes in stimulus presentation, and no expected or unexpected changes in the environment will be present, the tonic Skin Conductance Level (SCL) will be analysed, using mean microsiemens.
Measured: immediately post protocol (approx. 2 hours after baseline)
Brain activity
- Electroencephalography (EEG):
- EEG monitoring will be done using the MindMedia NEXUS-10MKII.
- Ten20 conductive paste for EEG is used in combination with Ag/AgCl disc electrodes.
- A positive electrode will be placed on Cz according to the international 10-20 system, a negative electrode will be placed on the left earlobe, and the ground electrode for EEG and ECG measurement will be placed on the right earlobe.
EEG measures:
- The impact of the cognitive fatigue and stress inducing protocol on alpha, beta, delta, and there frequency bands will be studied.
Measured: baseline
Brain activity
- Electroencephalography (EEG):
- EEG monitoring will be done using the MindMedia NEXUS-10MKII.
- Ten20 conductive paste for EEG is used in combination with Ag/AgCl disc electrodes.
- A positive electrode will be placed on Cz according to the international 10-20 system, a negative electrode will be placed on the left earlobe, and the ground electrode for EEG and ECG measurement will be placed on the right earlobe.
EEG measures:
- The impact of the cognitive fatigue and stress inducing protocol on alpha, beta, delta, and there frequency bands will be studied.
Measured: during protocol (approx. 1 hour after baseline)
Brain activity
- Electroencephalography (EEG):
- EEG monitoring will be done using the MindMedia NEXUS-10MKII.
- Ten20 conductive paste for EEG is used in combination with Ag/AgCl disc electrodes.
- A positive electrode will be placed on Cz according to the international 10-20 system, a negative electrode will be placed on the left earlobe, and the ground electrode for EEG and ECG measurement will be placed on the right earlobe.
EEG measures:
- The impact of the cognitive fatigue and stress inducing protocol on alpha, beta, delta, and there frequency bands will be studied.
Measured: immediately post protocol (approx. 2 hours after baseline)
Respiration
Respiration set up:
- The mind media NEXUS-10 MKII will be used for respiration measurement.
- An elastic band with sensor will be worn around the trunk at height of the umbilicus.
Respiration measures:
- Data will solely cover mechanical aspects of breathing.
- Only the respiration rate will be taken into analyses to study relations with previous neurophysiological measures.
- Also the breathing rate (BRPM) per minute will be analysed.
Measured: baseline
Respiration
Respiration set up:
- The mind media NEXUS-10 MKII will be used for respiration measurement.
- An elastic band with sensor will be worn around the trunk at height of the umbilicus.
Respiration measures:
- Data will solely cover mechanical aspects of breathing.
- Only the respiration rate will be taken into analyses to study relations with previous neurophysiological measures.
- Also the breathing rate (BRPM) per minute will be analysed.
Measured: during protocol (approx. 1 hour after baseline)
Respiration
Respiration set up:
- The mind media NEXUS-10 MKII will be used for respiration measurement.
- An elastic band with sensor will be worn around the trunk at height of the umbilicus.
Respiration measures:
- Data will solely cover mechanical aspects of breathing.
- Only the respiration rate will be taken into analyses to study relations with previous neurophysiological measures.
- Also the breathing rate (BRPM) per minute will be analysed.
Measured: immediately post protocol (approx. 2 hours after baseline)
Decline in Symbol Digit Modalities Test
The Symbol Digit Modalities Test (SDMT) Performance
- The SDMT is frequently used in the normal treatment and follow up of people with MS. Therefore, a customized version for this study is developed.
- Participants are shown one file with at the top a row as example consisting of symbols with related numbers. Beneath this row, a couple of rows with symbols are shown. The participant has to link the number to the specific symbol according to the example row. This as fast as possible within 90 seconds.
Scores
- A total score consisting of the total amount of correct answers will be determined.
- The SDMT will be divided in three equal parts of 30 seconds.
- For part1 part2, and part3 a correct score will be determined.
- Additionally, a cognitive fatigability score is determined: the difference between part3 versus part1.
Measured: immediately post protocol (approx. 2 hours after baseline)
Decline in N-Back Task
The N-Back Task (NBT)
Performance:
- The participants are shown a presentation of a series of letters. The participants have to respond with 'yes' whenever the same letter appeared as two letters previously.
- The participants perform two versions of this: with a 2- and 1-second interstimulus interval.
Scores:
- A total score consisting of the total amount of correct answers is determined.
- The NBT is then divided in three equal parts. For part1, part2, and part3, a total correct score is determined.
- Additionally, a cognitive fatigability score (i.e. difference between part3 and part1) is determined.
Measured: immediately post protocol (approx. 2 hours after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start15 Oct 2020
- Primary completion30 Aug 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- National MS Center Melsbroek
- Responsible party
- Principal investigator, Daphne Kos, KU Leuven
- Investigators
- Daphne Kos, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003375
- Sponsor's protocol ID
- S63552
- Acronym
- PREFIMS
- Status last verified
- Aug 2021
- First submitted
- 25 Jan 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Responses in Experimentally Induced Cognitive Fatigue in People With Multiple Sclerosis (MS): a Feasibility Study
- ClinicalTrials.gov ID
- NCT05003375
- Acronym / sponsor ID
- PREFIMS / S63552
- Conditions
- Multiple Sclerosis, Fatigue, Stress
- Keywords
- fatigability, cognitive fatigue, cognitive fatigability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- National MS Center Melsbroek
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis (MS) | – | Behavioral: High-challenging cognitive protocol to provoke stress and (cognitive) fatiguePeople with MS diagnosis, aged 18-55 years, Relapsing Remitting type, EDSS < 6.0, normal vision (if necessary corrected), Dutch speaking. |
| Healthy Controls (HC) | – | Behavioral: High-challenging cognitive protocol to provoke stress and (cognitive) fatigueHealthy controls without relevant health conditions (diabetes, thyroid diseases, neurological disorders), non-pregnant, aged 18-55 years, normal vision (if necessary corrected), Dutch speaking. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- relapse < 3 months (MS group)
- pregnancy
- relevant comorbidity (thyroid disease, diabetes, other neurological disorders, metabolic diseases, neuro-endocrine tumor(s)
- severe cognitive disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-challenging cognitive protocol to provoke stress and (cognitive) fatigueBaseline 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 | Behavioural | Healthy Controls (HC), Multiple Sclerosis (MS) |
Primary outcome
Change in heart rate variability (time-domain)
Time frame: immediately post protocol (approx. 2 hours after baseline)
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).
Change in heart rate variability (frequency-domain)
Time frame: immediately post protocol (approx. 2 hours after baseline)
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.
15 secondary outcomes
Change in Visual Analogue Scale (VAS) Momentary fatigue
Time frame: immediately post protocol (approx. 2 hours after baseline)
Change in Visual Analogue Scale (VAS) Momentary pain
Time frame: immediately post protocol (approx. 2 hours after baseline)
Usefulness, Satisfaction, and ease of use Questionnaire (USE)
Time frame: post protocol (approx. 2 hours after baseline)
NASA Task Load Index (NASA-TLX)
Time frame: post protocol (approx. 2 hours after baseline)
Galvanic Skin Response (GSR)
Time frame: baseline
Galvanic Skin Response (GSR)
Time frame: during protocol (approx. 1 hour after baseline)
Galvanic Skin Response (GSR)
Time frame: immediately post protocol (approx. 2 hours after baseline)
Brain activity
Time frame: baseline
Brain activity
Time frame: during protocol (approx. 1 hour after baseline)
Brain activity
Time frame: immediately post protocol (approx. 2 hours after baseline)
Respiration
Time frame: baseline
Respiration
Time frame: during protocol (approx. 1 hour after baseline)
Respiration
Time frame: immediately post protocol (approx. 2 hours after baseline)
Decline in Symbol Digit Modalities Test
Time frame: immediately post protocol (approx. 2 hours after baseline)
Decline in N-Back Task
Time frame: immediately post protocol (approx. 2 hours after baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daphne Kos, PhD principal investigator
KU Leuven
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Fatigue, run by KU Leuven at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daphne Kos, PhD (+32496-107849, daphne.kos@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in heart rate variability (time-domain) (time frame: immediately post protocol (approx. 2 hours after baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.