MRI in Diagnosing and Monitoring CIDP

Chronic Inflammatory Demyelinating Polyradiculoneuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02017769
• Other study ID #: 2012-100
• Status: Completed
• Phase: N/A
• First received: December 6, 2013
• Last updated: October 25, 2016
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Inflammatory Demyelinating Polyradiculoneuropathy
• Polyradiculoneuropathy
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Locations

Country	Name	City	State
Denmark	Department of Neurology, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DTI changes in nerves and muscles	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	At enrolment	No
Secondary	Changes in MRI findings between treated and untreated CIDP patients	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	All patients are examined at enrolment. Untreated patients are re-examined after 4 months of treatment	No
Secondary	Comparing clinical findings to MRI	Clinical evaluation by: Isokinetic dynamometry Clinical MRC score; These findings wil be compared to findings on MRI to assess an eventual correlation	At enrolment	No