Actively Recruiting
ActiCIDP Exploratory Study on Predicting CIDP Patients' Decline During Intravenous Immunoglobulins Treatment Adaptation
Led by Centre Hospitalier Universitaire de Liege · Updated on 2025-02-12
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Liege
Lead Sponsor
S
SYSNAV
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with Chronic Inflammatory Demyelinating Polyradiculoneuritis (CIDP) to explore the possibility of predicting disease progression during adjustments to intravenous immunoglobulin (IVIg) treatment. This academic study plans to include about 40 patients who have CIDP and are undergoing IVIg therapy. The aim is to closely monitor their condition and understand changes over time using various clinical and functional assessments. Participants will be assessed every three months over one year. During each visit, clinical examinations will include measures like the MRC sum score, mISS score, and I-RODS score. Functional tests such as the 6-minute walk test, myogrip measurement, and 9 Hole Peg Test will also be performed. Additionally, participants will wear the Actimyo device daily for one month following each visit. Actimyo is a home-based device consisting of two watch-like sensors that record movement data including acceleration and angular velocity. Throughout the study, researchers will gather data from clinical exams, functional tests, questionnaires, and Actimyo device monitoring to evaluate patients’ mobility and physical function. The primary outcomes include stride velocity and stride length measurements over one year. The study involves regular evaluations to track disease stability and monitor participants’ response to IVIg treatment. The total participation time is one year with quarterly visits and continuous device monitoring between visits.
CONDITIONS
Brief Title
Exploratory Study on Predicting CIDP Patients' Decline During IV Immunoglobulin Treatment Adaptation Feasibility.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with CIDP or possible CIDP based on 2021 EAN/PNS criteria
- Treated with intravenous immunoglobulin (IVIg) at a dose of 1 g/kg every 3 to 8 weeks or less
- Clinically stable disease for at least 3 months according to treating physician
- No treatment withdrawal failure within 1 year
- Age 18 years or older
You will not qualify if you...
- Significant cognitive or communication disorders
- Surgery or serious traumatic injury within the past 6 months
- Non-ambulant patient
- Current participation in a therapeutic trial
- Positive for anti-myeline antibodies (anti-MAG) or nodo-paranodopathy
- Other autoimmune diseases requiring corticosteroids, IVIg, or plasma exchange treatment
- Pregnancy or breastfeeding
- Any other condition that could interfere with patient evaluation or safety according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants wear two Actimyo devices in everyday life to record movement data. They also complete clinical examinations and tests including MRC sum score, mISS score, I-RODS score, 6-minute walk test, myogrip measurement, 9 Hole Peg Test, and questionnaires (mISS, INCAT, PGIC).
Regular visits for clinical assessments and device data collection
Trial Site Locations
Total: 1 location
1
CHR Citadelle
Liège, Liège, Belgium, 4000
Actively Recruiting
Research Team
L
Laurie Medard
M
Margaux Poleur, Dr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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