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Trial record 2 of 25 for:    nerve | CIDP

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
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date December 6, 2013
First Posted Date December 23, 2013
Last Update Posted Date October 26, 2016
Study Start Date May 2014
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 17, 2015)
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
Original Primary Outcome Measures
 (submitted: December 16, 2013)
MTR and DTI changes in nerves and muscles [ Time Frame: At enrolment ]
Magnetisation Transfer Ratios (MTR) and Diffusion Tension Imaging (DTI) in peripheral nerves and muscles in the lower extremities in CIDP patients and upper extremities in MMN patients treated with SCIG will be compared to healthy controls
Change History Complete list of historical versions of study NCT02017769 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 17, 2015)
  • 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
Original Secondary Outcome Measures
 (submitted: December 16, 2013)
  • 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 findings from ultrasound and MRI [ Time Frame: At enrolment ]
    Findings on MRI will be compared to findings on ultrasound imaging in CIDP and MMN patients and compared to healthy controls
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MRI in Diagnosing and Monitoring CIDP
Official Title Magnetic Resonance Imaging and Ultrasound Imaging of Peripheral Nerves in Patients Treated With Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy.
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

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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

Condition Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 25, 2016)
39
Original Estimated Enrollment
 (submitted: December 16, 2013)
37
Actual Study Completion Date May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02017769
Other Study ID Numbers 2012-100
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Aarhus
Study Sponsor University of Aarhus
Collaborators Not Provided
Investigators
Principal Investigator: Henning Andersen, Prof, DMSc
PRS Account University of Aarhus
Verification Date August 2016