Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu
Trial record 2 of 26 for:    nerve | CIDP

MRI in Diagnosing and Monitoring CIDP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02017769
Recruitment Status : Completed
First Posted : December 23, 2013
Last Update Posted : October 26, 2016
Information provided by (Responsible Party):
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

Condition or disease
Chronic Inflammatory Demyelinating Polyradiculoneuropathy

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

Layout table for study information
Study Type : Observational
Actual Enrollment : 39 participants
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.
Study Start Date : May 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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 from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02017769

Layout table for location information
Department of Neurology, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Layout table for investigator information
Principal Investigator: Henning Andersen, Prof, DMSc

Layout table for additonal information
Responsible Party: University of Aarhus Identifier: NCT02017769    
Other Study ID Numbers: 2012-100
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: August 2016
Keywords provided by University of Aarhus:
Subcutaneous immunoglobulin
Magnetic resonance imaging
Additional relevant MeSH terms:
Layout table for MeSH terms
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs