ClinicalTrialsFinder
RecruitingNCT05357781

Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)?

Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)? - A Prospective Observational Fatigue Trial

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

106 participants

Start Date

Jul 1, 2022

Study Type

OBSERVATIONAL

Conditions

FatigueMultiple SclerosisHypogammaglobulinemia

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

  • 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 Criteria8

  • 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

Interventions

DIAGNOSTIC_TESTLaboratory test

Frequency of fatigue (defined as Fatigue Scala for Motor and Cognitive Function (FSMC) total ≥ 43 points) in MS patients with IgG-deficiency

Locations(1)

University Hospital of Bern Inselspital

Bern, Canton of Bern, Switzerland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05357781

Related Trials

From Genetics to Transcriptomics to Unravel the Mechanisms Behind a Poor Outcome in Multiple Sclerosis

NCT048734921 location

Upper Limb Nerve Cryoneurolysis is Non Inferior to the Usual Care and Has Therapeutic Add Value in Dealing With Shoulder Pain and Functional Problems Caused by Spasticity and Motor Impairment

NCT067824641 location

Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis

NCT074776392 locations

Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer

NCT0381634552 locations

Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis

NCT072253611 location