MRI in Diagnosing and Monitoring CIDP
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|ClinicalTrials.gov Identifier: NCT02017769|
Recruitment Status : Completed
First Posted : December 23, 2013
Last Update Posted : October 26, 2016
|Condition or disease|
|Chronic Inflammatory Demyelinating Polyradiculoneuropathy|
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
|Study Type :||Observational|
|Actual Enrollment :||39 participants|
|Observational Model:||Case Control|
|Official Title:||Magnetic Resonance Imaging and Ultrasound Imaging of Peripheral Nerves in Patients Treated With Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy.|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
CIDP - treated
Patients diagnosed with CIDP and fulfilling the criteria by EFNS and PNS and in maintenance treatment with subcutaneous immunoglobulin
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
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017769
|Department of Neurology, Aarhus University Hospital|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Henning Andersen, Prof, DMSc|