|- candidate number||25270|
|- NTR Number||NTR6084|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-sep-2016|
|- Secondary IDs||2016/173 METc UMCG|
|- Public Title||Fatigue in patients with primary Sjogren’s syndrome|
|- Scientific Title||Fatigue in patients with primary Sjogren’s syndrome|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Sjogrens Syndrome, Fatigue, fMRI|
|- Inclusion criteria||Both patients and control subjects: |
- Age: 18-65 years
- Adequate hand function that allows subjects to utilize the force transducer
- 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
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||15-sep-2016|
|- planned closingdate||31-dec-2017|
|- Target number of participants||50|
|- Interventions||Fatigue protocol|
|- 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|
|- Timepoints||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.
|- Trial web site||n.a.|
|- CONTACT FOR PUBLIC QUERIES|| C.A.T. Zijdewind|
|- CONTACT for SCIENTIFIC QUERIES|| C.A.T. Zijdewind|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG)|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||8-sep-2016 - 11-nov-2016|