Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)?
Recruiting · NCT05357781 · Observational (researchers observe without assigning treatment) · Lead sponsor: Insel Gruppe AG, University Hospital Bern
View the official record on ClinicalTrials.gov →Interventions studied
Laboratory test
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
1 location listed.
- University Hospital of Bern Inselspital - Bern, Canton of Bern, Switzerland