MRI in Diagnosing and Monitoring CIDP

Completed

• Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy

• Registration Number: NCT02017769
• Lead Sponsor: University of Aarhus

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2013-12-06
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-23
• Study Start: 2014-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

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Exclusion Criteria

• Age < 18 or > 80 years
• Contraindications to MRI
• Pregnancy
• Other cause of neuropathy (incl. pressure neuropathy)
• Diabetes mellitus

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DTI changes in nerves and muscles	At enrolment	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

Secondary Outcome Measures

Name	Time	Method
Comparing clinical findings to MRI	At enrolment	Clinical evaluation by: Isokinetic dynamometry Clinical MRC score; These findings wil be compared to findings on MRI to assess an eventual correlation
Changes in MRI findings between treated and untreated CIDP patients	All patients are examined at enrolment. Untreated patients are re-examined after 4 months of treatment	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

Trial Locations

Locations (1)

Department of Neurology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark