Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)?
Recruiting now
Conditions studied: Hypogammaglobulinemia, Multiple Sclerosis, Fatigue
In brief
The investigators hypothesize that hypogammaglobulinemia (defined as IgG serum concentration \<7.0g/L) is a treatable cause of fatigue in people with MS: The primary objective is to prove the link between hypogammaglobulinemia and fatigue in patients with multiple sclerosis. The secondary objective is to show that fatigue is mediated via frequent infections in people with MS and hypogammaglobulinemia.
Key facts
- Study ID
- NCT05357781
- Run by
- Insel Gruppe AG, University Hospital Bern
- People needed
- 106
- Starts
- 2022-07-01
- Expected to finish
- 2026-12-30
- Last updated by the study team
- 2026-05-01
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of Multiple Sclerosis following McDonald 2017-Criteria
- Age 18-65 years
- Stable MS disease at inclusion (definition: no clinical relapse, no MRI activity, stable disability within the last 12 months)
- Unchanged immunotherapy within the last 12 months
- Expanded Disability Status Scale (EDSS) level <4 points indicating fully ambulatory patients.
- Capability of written informed consent
You may not qualify if…
- Severe depression (definition: Beck Depression Index-II (BDI-II) ≥29 points) or other established psychiatric diagnosis
- Immunodeficiency other than hypogammaglobulinemia
- Immunglobulin replacement therapy or indication for immunoglobulin replacement therapy
- Severe Sleepiness (definition: Epworth-Sleepiness-Scale (ESS) >16 points)
- Fatigue aggravating factors such: liver/renal/thyroid dysfunction, substance abuse, medication (tranquilizers /antiepileptics/psychopharmaceuticals), chronic infectious disease (like hepatitis/HIV).
- Other neurodegenerative/autoimmune disease.
- Patients not able to give written consent
- Vulnerable patients such as children, pregnant women and prisoners
Where it is running
- University Hospital of Bern Inselspital — Bern, Canton of Bern, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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