MRI in Diagnosing and Monitoring CIDP

Study Overview
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Brief Summary
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We want to study whether MRI can be useful in diagnosing and monitoring patients with CIDP in maintenance treatment with immunoglobulin

Detailed Description
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Chronic inflammatory neuropathies such as chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) can be successfully treated with immunoglobulin either intravenously (IVIG) or subcutaneously (SCIG). CIDP is diagnosed by electrophysiology which is time-consuming and unpleasant for the patient. New techniques suggest that Magnetic Resonance Imaging (MRI) and ultrasound imaging can be used to detect injuries in the peripheral nerves We want to study if MRI and ultrasound is able to detect damages in peripheral nerves, nerve roots and plexus in patients with CIDP. Moreover, we want to compare these findings to healthy matched controls and to see if treatment with immunoglobulin changes findings in MRI

Official Title
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Magnetic Resonance Imaging and Ultrasound Imaging of Peripheral Nerves in Patients Treated With Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy.

Conditions
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Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CIDP patients Age > 18 and < 80 years Diagnosed with definite and probable CIDP and fulfilling the European Federation of Neurological Sciences/Peripheral Nerve Society (EFNS/PNS) criteria Healthy controls Age > 18 and < 80 years No neurological disorders Exclusion Criteria: Age < 18 or > 80 years Contraindications to MRI Pregnancy Other cause of neuropathy (incl. pressure neuropathy) Diabetes mellitus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CIDP - treated<br>Patients diagnosed with CIDP and fulfilling the criteria by EFNS and PNS and in maintenance treatment with subcutaneous immunoglobulin | |
| Healthy controls<br>Healthy, gender and age matched controls | |
| CIDP - untreated<br>Patients newly diagnosed with CIDP and untreated are treated with immunoglobulin and re-examined after 4 months of treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DTI changes in nerves and muscles | Diffusion Tension Imaging (DTI) in peripheral nerves and muscles in the lower extremities in CIDP patients treated with SCIG will be compared to healthy controls | At enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in MRI findings between treated and untreated CIDP patients | Comparing changes in MTR and DTI between CIDP patients treated with subcutaneous immunoglobulin to those untreated. The untreated patients will be examined again after 4 months of treatment with immunoglobulin | All patients are examined at enrolment. Untreated patients are re-examined after 4 months of treatment | 
| Comparing clinical findings to MRI | Clinical evaluation by: Isokinetic dynamometry Clinical MRC score These findings wil be compared to findings on MRI to assess an eventual correlation | At enrolment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subcutaneous immunoglobulin, Magnetic resonance imaging