Fatigue in MS: From Invisible to Measurable

NCT07182903 | Completed

• 1 other identifier: FIMS
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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 immune system. The aim of this study is to investigate whether these cells can also be linked to fatigue in people with MS.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; fatigue; cytotoxic CD4 T cells

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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.

  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.

  Day 1

Secondary Outcomes (4)

• Changes in muscle activation during 6MWT

  Day 1

• Changes in muscle activation during foot tapping task

  Day 1

• Correlation changes in walking distance between the first and last minute of the 6MWT and CD4+ CTLs

  Day 1

• Correlation percentage voluntary muscle activation and CD4+ CTLs

  Day 1

Study Arms (1)

MS

Participants with multiple sclerosis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

40 pwMS

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• UHasselt: collaborator

Study Sites (1)

UMCG

Groningen, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 19, 2025
• Study Start: October 27, 2025
• Primary Completion: April 2, 2026
• Study Completion: April 2, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

NL (1)