The aim of this study is to investigate the effects of DMF (Tecfidera) on the association between fatigue and fatigability measures in pwRRMS starting with DMF medication.
ID
Source
Brief title
Condition
- Central nervous system infections and inflammations
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Association between fatigue (as measured with the FSS questionnaire) and
measures of fatigability (changes in index finger abductor force and voluntary
activation) in pwRRMS after 16 weeks of Tecfidera medication.
Secondary outcome
Secondary study parameters are: 1. changes in the decline in voluntary,
electrically evoked force and muscle activation during the fatiguing task
(fatigability measures), and 2. changes in FSS scores after 16 weeks of
Tecfidera medication (fatigue measures).
Background summary
Fatigue is an important symptom in persons with relapsing-remitting multiple
sclerosis (pwRRMS) which negatively affects quality of life.
Previous research showed that the perception of fatigue was associated with the
force decline during a 2-minute sustained contraction.
Dimethylfumarate (DMF) is a first-line oral MS drug prescribed by neurologist
as disease modifying therapy for pwRRMS. Beside an anti-inflammatory, an
anti-oxidative response is described for DMF and it is our hypothesis that the
inflammatory response in pwMS is an important contributor to fatigue in pwMS.
If during treatment with DMF the association between the perception of fatigue
and force decline exists and continues to exist, will this observation open the
possibility to use force decline as a means to objective fatigue.
Study objective
The aim of this study is to investigate the effects of DMF (Tecfidera) on the
association between fatigue and fatigability measures in pwRRMS starting with
DMF medication.
Study design
Single-blinded prospective experimental study. Investigators are blinded for
the group and session number
Intervention
Twee-minute contraction with the index finger abductor muscle.
Study burden and risks
Participant are measured 4 times during a 2-minute contraction. The
measurements take about 1.5 hours. During the contraction the nerve will be
electrically activated; no risks are associated with this stimulation but the
stimulation feel a little painful (like touching a electrical fence).
Hanzeplein 1
Groningen 9700AV
NL
Hanzeplein 1
Groningen 9700AV
NL
Listed location countries
Age
Inclusion criteria
* Informed consent
* Age: 18 * 55 years
Additional criteria for pwRRMS:
* A diagnosis of RRMS according to the McDonald criteria
* A baseline Expanded Disability Status Scale <4.5
* Newly initiating treatment with DMF (Tecfidera) under routine clinical care
* Adequate hand function that allows subjects to utilize the force transducer (as determined by the neurologist).
Exclusion criteria
* 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62864.042.17 |
| Other | NTR 28290 |