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MRI in Diagnosing and Monitoring CIDP

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT02017769
Collaborator
(none)
39
Enrollment
1
Location
24
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 1, 2014
    Actual Primary Completion Date :
    May 1, 2016
    Actual Study Completion Date :
    May 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Department of Neurology, Aarhus University Hospital Aarhus Denmark 8000

    Sponsors and Collaborators

    • University of Aarhus

    Investigators

    • Principal Investigator: Henning Andersen, Prof, DMSc,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT02017769
    Other Study ID Numbers:
    • 2012-100
    First Posted:
    Dec 23, 2013
    Last Update Posted:
    Oct 26, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by University of Aarhus
    Subcutaneous immunoglobulin
    Magnetic resonance imaging
    Additional relevant MeSH terms:
    Polyradiculoneuropathy
    Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

    Study Results

    No Results Posted as of Oct 26, 2016