Fatigue in MS: From Invisible to Measurable

NCT ID: NCT07182903

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2025-12-31

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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

MS

Participants with multiple sclerosis

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UHasselt

UNKNOWN

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Nikki Dreijer

Role: CONTACT

n.dreijer@umcg.nl

+31625647172

Other Identifiers

19721

Identifier Type: -

Identifier Source: org_study_id