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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02017769
Other study ID # 2012-100
Secondary ID
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
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