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

NCT05357781 | Recruiting

• 1 other identifier: 2021-02372
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypogammaglobulinemia; Multiple Sclerosis; Fatigue

Keywords

Fatigue; Hypogammaglobulinemia

Outcome Measures

Primary Outcomes (2)

• Number of patients with fatigue and hypogammaglobulinemia

  The primary endpoint will be measured as frequency (%) of fatigue (defined as Fatigue Scala for Motor and Cognitive Function (FSMC) total ≥ 43 points) in MS patients with IgG-deficiency (IgG serum concentration \<7.0 g/L) compared to those with normal IgG-serum concentration (≥ 7.0 g/L). The FSMC is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue) FSMC Sum Score: ≥ 43 points mild fatigue, ≥ 53 points moderate fatigue, ≥ 63 severe fatigue

  1.5 years

• Number of patients with fatigue without hypogammaglobulinemia

  The primary endpoint will be measured as frequency (%) of fatigue (defined as Fatigue Scala for Motor and Cognitive Function (FSMC) total ≥ 43 points) in MS patients with IgG-deficiency (IgG serum concentration \<7.0 g/L) compared to those with normal IgG-serum concentration (≥ 7.0 g/L). The FSMC is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue) FSMC Sum Score: ≥ 43 points mild fatigue, ≥ 53 points moderate fatigue, ≥ 63 severe fatigue

  1.5 years

Secondary Outcomes (1)

• Fatigue and infections

  1.5 years

Study Arms (2)

MS patients with IgG deficiency (serum IgG-concentration <7g/L).

MS patients with IgG deficiency (serum IgG-concentration \<7g/L).

Diagnostic Test: Laboratory test

MS patients with normal IgG serum concentration (serum IgG-concentration ≥7g/L).

MS patients with normal IgG serum concentration (serum IgG-concentration ≥7g/L).

Diagnostic Test: Laboratory test

Interventions

Laboratory test DIAGNOSTIC_TEST

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

Also known as: Fatigue Score

MS patients with IgG deficiency (serum IgG-concentration <7g/L).; MS patients with normal IgG serum concentration (serum IgG-concentration ≥7g/L).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Multiple Sclerosis Patients

You may qualify if:

• Diagnosis of Multiple Sclerosis following McDonald 2017-Criteria
• Age 18-65 years
• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital of Bern Inselspital

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Agammaglobulinemia; Multiple Sclerosis; Fatigue

Interventions

Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Lara Diem, MD

  Inselspital University Hospital of Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lara Diem, MD

CONTACT

0041316327000; larafrancesca.diem@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 3, 2022
• Study Start: July 1, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)