MRI in Diagnosing and Monitoring CIDP

N/ACompletedNCT02017769

University of Aarhus39 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department of Neurology, Aarhus University Hospital

Aarhus, Denmark

Outcomes

Primary Outcomes

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

Time frame: At enrolment

Secondary Outcomes

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

Time frame: 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

Time frame: At enrolment

Data from ClinicalTrials.gov

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