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Completed

NCT Number: NCT02017769

MRI in Diagnosing and Monitoring CIDP

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

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Key information

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Diseases Disease Attributes Immune System Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology, Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

    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

    Time frame: At enrolment

    Clinical evaluation by:

    Isokinetic dynamometry Clinical MRC score

    These findings wil be compared to findings on MRI to assess an eventual correlation

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 23, 2013
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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