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Clinical Trials/NCT02017769
NCT02017769
Completed
Not Applicable

Magnetic Resonance Imaging and Ultrasound Imaging of Peripheral Nerves in Patients Treated With Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy.

University of Aarhus1 site in 1 country39 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Sponsor
University of Aarhus
Enrollment
39
Locations
1
Primary Endpoint
DTI changes in nerves and muscles
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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

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

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
May 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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
  • 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

Outcomes

Primary Outcomes

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 Outcomes

  • Comparing clinical findings to MRI(At enrolment)
  • 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)

Study Sites (1)

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