MRI in Diagnosing and Monitoring CIDP

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: December 6, 2013
Last updated: August 17, 2015
Last verified: August 2015

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

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

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.

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • DTI changes in nerves and muscles [ Time Frame: At enrolment ] [ Designated as safety issue: No ]
    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:
  • 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 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: 40
Study Start Date: May 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 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
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) 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


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 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 17, 2015
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Subcutaneous immunoglobulin
Magnetic resonance 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 October 09, 2015