Fatigue, Fatigability, relapsing-remitting multiple sclerosis, force, dimethyl fumarate
Conditions
Interventions
2-minute sustained index finger abduction
Sponsors
University Medical Center Groningen
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Informed consent • Age: 18 – 55 years • Adequate hand function that allows subjects to utilize the force transducer (as determined by the neurologist) Additional inclusion criteria for pwRRMS: • Newly initiating treatment with DMF (Tecfidera) under routine clinical care • A diagnosis of RRMS according to the McDonald criteria • A baseline Expanded Disability Status Scale <4.5
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • History of alcohol or drug abuse or current alcohol or drug abuse • Neurologic condition unrelated to MS Psychiatric disorder (including affective disorders). • Other conditions/diseases influencing fatigue: o Chronic fatigue syndrome • Primary immunodeficiency. • Treatment with steroids within one month prior to inclusion • Participation in an investigational drug study within 3 months prior to inclusion • A MS relapse within one month prior to inclusion • Medication: o 4-aminopyridine or another form of fampridine o antidepressant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Description of the association between measures of fatigability and fatigue in pwRRMS after 16 weeks of treatment with dimethyl fumarate (Tecfidera). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Description of the effect of 16-week treatment with DMF on fatigue as quantified with the Fatigue severity scale (FSS) in pwRRMS. 2) Description of the effect of 16-week treatment with DMF on fatigability as quantified by a decline in muscle force and changes in voluntary drive in relapsing-remitting MS patients. | — |
Contacts
Public ContactC.A.T. Zijdewind
Dept Neuroscience, Section Medical Physiology, HPC-FB43 University Medical Center Groningen
Outcome results
None listed