Clinical Trial: MRI in Diagnosing and Monitoring CIDP

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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

Detailed Summary:

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


Sponsor: University of Aarhus

Current Primary Outcome: DTI changes in nerves and muscles [ Time Frame: 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


Original Primary Outcome: MTR and DTI changes in nerves and muscles [ Time Frame: At enrolment ]

Magnetisation Transfer Ratios (MTR) and Diffusion Tension Imaging (DTI) in peripheral nerves and muscles in the lower extremities in CIDP patients and upper extremities in MMN patients treated with SCIG will be compared to healthy controls


Current Secondary Outcome:

  • Changes in MRI findings between treated and untreated CIDP patients [ Time Frame: 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

  • Comparing clinical findings to MRI [ Time Frame: At enrolment ]

    Clinical evaluation by:

    Isokinetic dynamometry Clinical MRC score

    These findings wil be compared to findings on MRI to assess an eventual correlation



Original Secondary Outcome:

  • Changes in MRI findings between treated and untreated CIDP patients [ Time Frame: 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

  • Comparing findings from ultrasound and MRI [ Time Frame: At enrolment ]
    Findings on MRI will be compared to findings on ultrasound imaging in CIDP and MMN patients and compared to healthy controls
  • Comparing clinical findings to MRI [ Time Frame: At enrolment ]

    Clinical evaluation by:

    Isokinetic dynamometry Clinical MRC score

    These findings wil be compared to findings on MRI to assess an eventual correlation



Information By: University of Aarhus

Dates:
Date Received: December 6, 2013
Date Started: May 2014
Date Completion:
Last Updated: October 25, 2016
Last Verified: August 2016