MRI in Diagnosing and Monitoring CIDP

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02017769

Enrollment

Registered

2013-12-23

Start date

2014-05-31

Completion date

2016-05-31

Last updated

2016-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Keywords

Subcutaneous immunoglobulin, Magnetic resonance imaging

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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

Countries

Denmark

Outcome results