Actively Recruiting
Immunoglobulin M (IgM)-Anti-myelin-associated-glycoprotein(MAG) Peripheral Neuropathy Study
Led by Hospices Civils de Lyon · Updated on 2026-01-20
45
Participants Needed
2
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
There is no international consensus regarding how to assess and treat patients with immunoglobulin M (IgM)-anti-myelin-associated-glycoprotein (MAG) monoclonal gammopathy associated peripheral neuropathy. The purpose of the IMAGiNe study-Lyon/Bicêtre is to prospectively collect standardized clinical data of 25 patients with IgM-anti-MAG monoclonal gammopathy associated peripheral neuropathy in order to participate in the international IMAGiNe Study. The main objective is to describe in detail the various clinical subtypes, clinical course, treatment responses, antibody titers of IgM-anti-MAG monoclonal gammopathy associated peripheral neuropathy using a variety of outcome measures. The obtained observational data will allow the construction of an IgM monoclonal gammopathy associated peripheral neuropathy-specific Rasch-built overall Disability Scale (RODS) that should fulfill all modern clinimetric requirements, including cross-cultural validity. The coordinating centers for the IgM-RODS construction will be the Maastricht University Medical Center and University Medical Center Utrecht, both in the Netherlands.
CONDITIONS
Official Title
Immunoglobulin M (IgM)-Anti-myelin-associated-glycoprotein(MAG) Peripheral Neuropathy Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fulfill international criteria for diagnosis of Immunoglobulin M (IgM) monoclonal gammopathy with anti-myelin-associated-glycoprotein (MAG) antibodies and peripheral neuropathy
- Be 18 years of age or older
- Provide informed consent and be followed in the neuromuscular department of Lyon
You will not qualify if you...
- Have diseases that might affect peripheral nerve or physical function such as diabetes, kidney failure, prior chemotherapy for other diseases, hereditary neuropathy, vitamin deficiency, connective tissue disorders, hepatitis B or C, HIV infection, or alcohol abuse exceeding 5 International Units per day
- Have an active cancer with poor prognosis undergoing treatment other than for monoclonal gammopathy associated peripheral neuropathy
- Are pregnant
- Use medication that may affect peripheral nerve function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hospices Civils de Lyon Service Neurologie C, Pathologies Neuromusculaires, Unité 302
Bron, France, 69500
Actively Recruiting
2
Centre de référence NNERf
Le Kremlin-Bicêtre, France, 94275
Actively Recruiting
Research Team
J
Juliette SVAHN, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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