Chronic Inflammatory Demyelinating PolyradiculoneuropathyNCT02017769
MRI in Diagnosing and Monitoring CIDP
An observational study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy, run by University of Aarhus at 1 site in Denmark.
Trial summary
We want to study whether MRI can be useful in diagnosing and monitoring patients with CIDP in maintenance treatment with immunoglobulin Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Type of treatment
- Injection or infusion
- How many people
- 39 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Age < 18 or > 80 years
- Contraindications to MRI
- Pregnancy
- Other cause of neuropathy (incl. pressure neuropathy)
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Neurology, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: Magnetic Resonance Imaging and Ultrasound Imaging of Peripheral Nerves in Patients Treated With Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy.
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
- Keywords
- Subcutaneous immunoglobulin, Magnetic resonance imaging
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At enrolment
Secondary outcomes (2)
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
Measured: All patients are examined at enrolment. Untreated patients are re-examined after 4 months of treatment
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
Measured: At enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating PolyradiculoneuropathyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henning Andersen, Prof, DMSc, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017769
- Sponsor's protocol ID
- 2012-100
- Status last verified
- Aug 2016
- First submitted
- 6 Dec 2013
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging and Ultrasound Imaging of Peripheral Nerves in Patients Treated With Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy.
- ClinicalTrials.gov ID
- NCT02017769
- Acronym / sponsor ID
- 2012-100
- Keywords
- Subcutaneous immunoglobulin, Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Age < 18 or > 80 years
- Contraindications to MRI
- Pregnancy
- Other cause of neuropathy (incl. pressure neuropathy)
- Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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 clinical findings to MRI
Time frame: At enrolment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henning Andersen, Prof, DMSc principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DTI changes in nerves and muscles (time frame: At enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.