MRI and Ultrasound Imaging in Diagnosing and Monitoring CIDP and MMN

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: December 6, 2013
Last updated: December 2, 2014
Last verified: November 2013

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

Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Multifocal Motor Neuropathy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Magnetic Resonance Imaging and Ultrasound Imaging of Peripheral Nerves in Patients Treated With Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy and Multifocal Motor Neuropathy

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • MTR and DTI changes in nerves and muscles [ Time Frame: At enrolment ] [ Designated as safety issue: No ]
    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

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    Clinical evaluation by:

    Isokinetic dynamometry Clinical MRC score

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

Estimated Enrollment: 37
Study Start Date: May 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
CIDP - treated
Patients diagnosed with CIDP and fulfilling the criteria by EFNS and PNS and in maintenance treatment with subcutaneous immunoglobulin
MMN - treated
Patients diagnosed with MMN and fulfilling the criteria by EFNS and PNS and in maintenance treatment with subcutaneous immunoglobulin
Healthy controls
Healthy, gender and age matched controls
CIDP - untreated
Patients newly diagnosed with CIDP and untreated are treated with immunoglobulin and re-examined after 4 months of treatment

Detailed Description:

Chronic inflammatory neuropathies such as chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN) can be successfully treated with immunoglobulin either intravenously (IVIG) or subcutaneously (SCIG).

CIDP and MMN are 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 or MMN.

Moreover, we want to compare these findings to healthy matched controls and to see if treatment with immunoglobulin changes findings in MRI and ultrasound


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients treated with subcutaneous immunoglobulin for CIDP and MMN are invited to participate. They will be recruited from the outpatient clinic at Department of Neurology in Aarhus, Odense and at Rigshospitalet (Copenhagen)

Healthy controls will be recruited by public announcement


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

MMN patients

  • Age > 18 and < 80 years
  • Diagnosed with definite or probable MMN and fulfilling the 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

  Contacts and Locations
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Please refer to this study by its identifier: NCT02017769

Department of Neurology, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Principal Investigator: Henning Andersen, Prof, DMSc
  More Information

No publications provided

Responsible Party: University of Aarhus Identifier: NCT02017769     History of Changes
Other Study ID Numbers: 2012-100
Study First Received: December 6, 2013
Last Updated: December 2, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Subcutaneous immunoglobulin
Magnetic resonance imaging
Ultrasound imaging

Additional relevant MeSH terms:
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Demyelinating Diseases
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Immune System Diseases
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs processed this record on March 31, 2015