Multiple SclerosisFIMSNCT07182903
Fatigue in MS: From Invisible to Measurable
An observational study of Multiple Sclerosis, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Fatigue is one of the most common and burdensome symptoms of MS, but its precise cause remains unknown, and an effective treatment is lacking. Previous research has shown that the progression of MS is associated with a higher presence of a specific type of T-cell, the cytotoxic CD4+ T-cells, which play a role in the… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Oct 2025to 2 Apr 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 40 pwMS
Who may be able to join
- Diagnosis of relapsing remittion, primary progressive or secondary progressive MS
- Age: 18-60 years
- Ability to perform the foot-tapping task
- Ability to walk at least 20 meters (with or without walking aid)
Who cannot join
- Dimethyl fumarate, fingolimod or alemtuzumab treatment, since these medications have a strong influence on the immune system As a result of these treatments, there are few to no immune cells circulating in the blood, meaning we cannot find our population of interest in the blood.
- Change in medication 6 weeks before the start of the study (including medication not related to MS) - MS relapse within 6 weeks of the start of the study
- Had an infection in the last month - Received a vaccination in the last 14 days - Pregnant or pregnancy in the last 6 months
- Having a psychiatric disorder
- Having a neurological disorder other than MS
- Having cognitive or communicative problems that makes it hard to follow instructions
Trial locations and contacts
1 site in 1 country.
About this study
Fatigue is one of the most common and burdensome symptoms of MS, but its precise cause remains unknown, and an effective treatment is lacking. Previous research has shown that the progression of MS is associated with a higher presence of a specific type of T-cell, the cytotoxic CD4+ T-cells, which play a role in the immune system.
The aim of this study is to investigate whether these cells can also be linked to fatigue in people with MS.
Read the detailed description
Forty individuals with MS will be asked to complete questionnaires about fatigue and perform motor tasks. Additionally, blood samples will be taken to measure the levels of cytotoxic CD4+ T-cells. These values will then be correlated with fatigue scores and performance on the motor tasks.
Scores from the fatigue questionnaires and decline in amplitude and frequency from the performance fatiguability test will be correlated to the level of CD4 CTLs from the blood samples. Secondary study parameters include muscle activation patterns measured by EMG, distance walked on 6MWT and voluntary muscle activation.
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, fatigue, cytotoxic CD4 T cells
- 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.
| Study group | Role | What they receive |
|---|---|---|
| MS | Participants with multiple sclerosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between percentage of cytotoxic CD4+ T cells and FSS score
Bivariate correlations will be calculated between the percentage of cytotoxic CD4+ T cells and fatigue, measured with Fatigue Severity Scale (FSS).
Measured: Day 1
Correlation between percentage of cytotoxic CD4+ T cells and MFIS score
Bivariate correlations will be calculated between the percentage of cytotoxic CD4+ T cells and fatigue, measured with Modified Fatigue Impact Scale (MFIS).
Measured: Day 1
Correlation between percentage of cytotoxic CD4+ T cells and foot-tapping frequency decrease
Bivariate correlations will be calculated between the percentage of cytotoxic CD4+ T cells and fatigability, measured as the decrease in frequency from the first 10 seconds of the task to the last 10 seconds of the task.
Measured: Day 1
Correlation between percentage of cytotoxic CD4+ T cells and foot-tapping amplitude decrease
Bivariate correlations will be calculated between the percentage of cytotoxic CD4+ T cells and fatigability, measured as the decrease in amplitude from the first 10 seconds of the task to the last 10 seconds of the task.
Measured: Day 1
Secondary outcomes (4)
Changes in muscle activation during 6MWT
Comparison of the root-mean-square (RMS) of the EMG signal at the beginning of the task and the end of the task.
Measured: Day 1
Changes in muscle activation during foot tapping task
Comparison of the root-mean-square (RMS) of the EMG signal at the beginning (first 10 seconds) of the task and the end (last 10 seconds) of the task.
Measured: Day 1
Correlation changes in walking distance between the first and last minute of the 6MWT and CD4+ CTLs
Changes in distance between the first minute and the last minute of the 6MWT are measured to assess walking fatigability and will be correlated with the percentage of CD4+ CTLs in the blood.
Measured: Day 1
Correlation percentage voluntary muscle activation and CD4+ CTLs
The correlation is calculated between the percentage of CD4+ CTLs in the blood and the percentage of voluntary activation (1 - superimposed twitch/initial-doublet) x 100%).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start27 Oct 2025
- Primary completion2 Apr 2026
- Study completion2 Apr 2026
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 University Medical Center GroningenThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- UHasselt
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182903
- Sponsor's protocol ID
- FIMS
- Acronym
- FIMS
- Status last verified
- Apr 2026
- First submitted
- 3 Sep 2025
- Last updated
- 20 Apr 2026
- 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue in MS: From Invisible to Measurable
- ClinicalTrials.gov ID
- NCT07182903
- Acronym / sponsor ID
- FIMS / FIMS
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, fatigue, cytotoxic CD4 T cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- UHasselt
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 19 Sep 2025 (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.
Fatigue is one of the most common and burdensome symptoms of MS, but its precise cause remains unknown, and an effective treatment is lacking. Previous research has shown that the progression of MS is associated with a higher presence of a specific type of T-cell, the cytotoxic CD4+ T-cells, which play a role in the immune system.
The aim of this study is to investigate whether these cells can also be linked to fatigue in people with MS.
Detailed description
Forty individuals with MS will be asked to complete questionnaires about fatigue and perform motor tasks. Additionally, blood samples will be taken to measure the levels of cytotoxic CD4+ T-cells. These values will then be correlated with fatigue scores and performance on the motor tasks.
Scores from the fatigue questionnaires and decline in amplitude and frequency from the performance fatiguability test will be correlated to the level of CD4 CTLs from the blood samples. Secondary study parameters include muscle activation patterns measured by EMG, distance walked on 6MWT and voluntary muscle activation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS | – | –Participants with multiple sclerosis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 40 pwMS
Key inclusion criteria (4 listed)
- Diagnosis of relapsing remittion, primary progressive or secondary progressive MS
- Age: 18-60 years
- Ability to perform the foot-tapping task
- Ability to walk at least 20 meters (with or without walking aid)
Key exclusion criteria (6 listed)
- Dimethyl fumarate, fingolimod or alemtuzumab treatment, since these medications have a strong influence on the immune system As a result of these treatments, there are few to no immune cells circulating in the blood, meaning we cannot find our population of interest in the blood.
- Change in medication 6 weeks before the start of the study (including medication not related to MS) - MS relapse within 6 weeks of the start of the study
- Had an infection in the last month - Received a vaccination in the last 14 days - Pregnant or pregnancy in the last 6 months
- Having a psychiatric disorder
- Having a neurological disorder other than MS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between percentage of cytotoxic CD4+ T cells and FSS score
Time frame: Day 1
Bivariate correlations will be calculated between the percentage of cytotoxic CD4+ T cells and fatigue, measured with Fatigue Severity Scale (FSS).
Correlation between percentage of cytotoxic CD4+ T cells and MFIS score
Time frame: Day 1
Bivariate correlations will be calculated between the percentage of cytotoxic CD4+ T cells and fatigue, measured with Modified Fatigue Impact Scale (MFIS).
Correlation between percentage of cytotoxic CD4+ T cells and foot-tapping frequency decrease
Time frame: Day 1
Bivariate correlations will be calculated between the percentage of cytotoxic CD4+ T cells and fatigability, measured as the decrease in frequency from the first 10 seconds of the task to the last 10 seconds of the task.
Correlation between percentage of cytotoxic CD4+ T cells and foot-tapping amplitude decrease
Time frame: Day 1
Bivariate correlations will be calculated between the percentage of cytotoxic CD4+ T cells and fatigability, measured as the decrease in amplitude from the first 10 seconds of the task to the last 10 seconds of the task.
4 secondary outcomes
Changes in muscle activation during 6MWT
Time frame: Day 1
Changes in muscle activation during foot tapping task
Time frame: Day 1
Correlation changes in walking distance between the first and last minute of the 6MWT and CD4+ CTLs
Time frame: Day 1
Correlation percentage voluntary muscle activation and CD4+ CTLs
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Multiple Sclerosis
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Not yet recruitingPhase 1
A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis
Recruiting
Virtual Reality Versus Mental Practice On Balance And Gait In Patients With Multiple Sclerosis
Multiple Sclerosis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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, run by University Medical Center Groningen at 1 site in Netherlands.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between percentage of cytotoxic CD4+ T cells and FSS score (time frame: Day 1). The study lists 4 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 20 Apr 2026.