MRI in Diagnosing and Monitoring CIDP

NCT02017769 | Completed

• 1 other identifier: 2012-100
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Keywords

Subcutaneous immunoglobulin; Magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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 clinical findings to MRI

  At enrolment

Study Arms (3)

CIDP - treated

Patients diagnosed with CIDP 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with subcutaneous immunoglobulin for CIDP 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

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 or \> 80 years
• Contraindications to MRI
• Pregnancy
• Other cause of neuropathy (incl. pressure neuropathy)
• Diabetes mellitus

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Neurology, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

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

Study Officials

• Henning Andersen, Prof, DMSc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 23, 2013
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-08

Locations

DK (1)