ClinicalTrials.gg
CompletedNCT02017769Updated Oct 26, 2016

MRI in Diagnosing and Monitoring CIDP

An observational study in Chronic Inflammatory Demyelinating Polyradiculoneuropathy, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-26.

Sponsored by University of Aarhus · Observational

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
39
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 24 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Denmark — 8 open to participants now, 11 under way, 6 of them phase 3. Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · Denmark.

Started
2014
with 2 others
Observational
7 of 24
1 open now
Registered
4th of 24
by date
Lead sponsor
6 of 24
University of Aarhus

Among the 24 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Denmark, this one is one of 3 that started in 2014, is one of 7 observational ones, and was the 4th registered.

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.

Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →

Open to participants now

8 of the 24 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Denmark are open now. Recruiting first, the newest first:

3 more — sign in →

All 8 open studies →

A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →

Who these studies take

Of the 36 Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies recruiting now, 24 (67%) set no upper age limit and 9 (25%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · healthy volunteers too.

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02

Study summary

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

Read the 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

03

Conditions studied

  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Keywords

  • Subcutaneous immunoglobulin
  • Magnetic resonance imaging
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Age \< 18 or > 80 years
  • to MRI
  • Pregnancy
  • Other cause of neuropathy (incl. pressure neuropathy)
  • Diabetes mellitus
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
39 participants (actual)
Patient registry
No

Groups and 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

06

What researchers measure

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

    Time frame: At enrolment

Secondary outcomes

  1. 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

    Time frame: All patients are examined at enrolment. Untreated patients are re-examined after 4 months of treatment

  2. 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

    Time frame: At enrolment

07

Study locations

1 site
  • Department of Neurology, Aarhus University Hospital
    Aarhus, 8000, Denmark
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2014, a primary completion of May 2016 and a completion of May 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 6, 2013
First posted
Dec 23, 2013
Start
May 2014
Primary completionActual
May 2016
CompletionActual
May 2016
Last update
Oct 26, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02017769
Responsible party
Sponsor
First posted
Dec 23, 2013
Start date
May 2014
Primary completion
May 2016
Completion
May 2016
Last update
Oct 26, 2016

Study contacts

Henning Andersen, Prof, DMSc
principal investigator

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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