No registrations found.
ID
Source
Health condition
Primary Sjögren's syndrome (pSS)
Fatigue
fMRI
Cytokines
Primaire syndroom van Sjögren
Vermoeidheid
fMRI
Cytokines
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Maximal force of the first dorsal interosseous (FDI) muscle
- Force decline during the fatiguing task
- Muscle activation during the fatiguing task
- Questionnaire scores
- Changes in cortical activation during the fatiguing task (functional MRI data).
Secondary outcome
- Ectromyographic activity of the FDI muscle during the motor tasks
Study objective
Fatigue in patients with primary Sjögren's syndrome can be explained by force decline during a fatiguing task, muscle activation, mood, and the serum levels of proinflammatory cytokines.
Patients with primary Sjögren's syndrome will show attenuated task-related cortical activation compared to control subjects and/or an attenuated increase in activation of effort-related areas.
Study design
The study comprises two sessions lasting approximately two hours. The first session takes place at the department of neuroscience. Subjects perform 3 motor tasks during which they have to produce force with their index fingers (FDI muscle). The ulnar nerve is activated using electrical stimulation to determine the muscle activation.
The second session takes place at the neuroimaging center to repeat the motor tasks in the MR-scanner. Changes in cortical activation during the tasks are measured using a 3T MR-scanner. Muscle force is measured using MR-compatible force transducers, and muscle activation is measured by stimulating the ulnar nerve with MR-compatible surface electrodes.
During the study, subjects are asked to fill out six questionnaires*. For the serum levels of proinflammatory cytokines, data from a cohort study will be used and no additional material needs to be collected from pSS patients.
* Fatigue: Fatigue Severity Scale, Modified Fatigue Impact Scale, Multidimensional Fatigue Inventory. Mood: Hospital Anxiety and Depression Scale. Disease activity: EULAR Sjögren’s Syndrome Patient Reported Index, patient acceptable symptom state.
Intervention
Fatigue protocol
University Medical Center Groningen
C.A.T. Zijdewind
Ant. Deusinglaan 1 P.O.Box 196
Groningen 9713 AV
The Netherlands
+31503616438
c.a.t.zijdewind@umcg.nl
University Medical Center Groningen
C.A.T. Zijdewind
Ant. Deusinglaan 1 P.O.Box 196
Groningen 9713 AV
The Netherlands
+31503616438
c.a.t.zijdewind@umcg.nl
Inclusion criteria
Both patients and control subjects:
- Age: 18-65 years
- Adequate hand function that allows subjects to utilize the force transducer
Patients:
- Diagnosed with pSS according to AECG and/or ACR-EULAR classification criteria
Exclusion criteria
Both patients and control subjects:
- Drug or alcohol addicition
- Neurologic condition unrelated to pSS
- Psychiatric disorder
- Other condition influencing fatigue
- Medication influencing fatigue or the immune system
- fMRI related exclusion criteria
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 |
---|---|
NTR-new | NL5896 |
NTR-old | NTR6084 |
Other | METc UMCG : 2016/173 |