Exploring the link between immunoglobulin deficiency and fatigue in multiple sclerosis patients
Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)? - A Prospective Observational Fatigue Trial
This study is trying to see if low levels of a certain antibody in people with multiple sclerosis can be a cause of their fatigue and if treating it could help them feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 106 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Bern, Canton of Bern) |
| Trial ID | NCT05357781 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate whether hypogammaglobulinemia, characterized by low IgG serum levels, is a treatable cause of fatigue in patients with multiple sclerosis (MS). The primary objective is to establish a connection between hypogammaglobulinemia and fatigue, while the secondary objective focuses on understanding if fatigue is exacerbated by frequent infections in these patients. The study will involve laboratory tests to assess immunoglobulin levels in individuals diagnosed with MS who meet specific inclusion criteria. By identifying potential treatable factors contributing to fatigue, the study seeks to improve the quality of life for MS patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with a stable diagnosis of multiple sclerosis and no significant psychiatric or immunodeficiency issues.
Not a fit: Patients with severe depression, other forms of immunodeficiency, or those already receiving immunoglobulin replacement therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for fatigue in multiple sclerosis patients by addressing underlying immunoglobulin deficiencies.
How similar studies have performed: While studies have shown correlations between immunoglobulin therapy and fatigue in other conditions, this specific approach in multiple sclerosis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bern, Canton of Bern
- University Hospital of Bern Inselspital — Bern, Canton of Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Lara Diem, MD — Inselspital University Hospital of Bern
- Study coordinator: Lara Diem, MD
- Email: larafrancesca.diem@insel.ch
- Phone: 0041316327000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.