MRI and Ultrasound Imaging in Diagnosing and Monitoring CIDP and MMN

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT02017769
First received: December 6, 2013
Last updated: December 16, 2013
Last verified: November 2013
  Purpose

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


Condition
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: January 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

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

Criteria

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
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 ClinicalTrials.gov identifier: NCT02017769

Contacts
Contact: Henning Andersen, Prof, DMSC hennande@rm.dk
Contact: Lars H Markvardsen, MD +45 7846 3337 larsmark@rm.dk

Locations
Denmark
Department of Neurology, Aarhus University Hospital Not yet recruiting
Aarhus, Denmark, 8000
Contact: Lars H Markvardsen, MD    +45 7846 3337    larsmark@rm.dk   
Sub-Investigator: Lars H Markvardsen, MD         
Principal Investigator: Henning Andersen, Prof, DMSc         
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Henning Andersen, Prof, DMSc
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02017769     History of Changes
Other Study ID Numbers: 2012-100
Study First Received: December 6, 2013
Last Updated: December 16, 2013
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
Polyneuropathies
Polyradiculoneuropathy
Neuritis
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014