Exploratory Study on Predicting CIDP Patients' Decline During IV Immunoglobulin Treatment Adaptation Feasibility.
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy
- Registration Number
- NCT06183645
- Lead Sponsor
- Centre Hospitalier Universitaire de Liege
- Brief Summary
ActiCIDP is a monocentric academic study. Patients with Chronic inflammatory demyelinating polyradiculoneuritis may be included on a voluntary basis.
The investigators plan to include a group of approximately 40 patients with CIDP.
The investigators have planned to assess patient every three months for a year. After each visit, participants will wear Actimyo for one month daily.
- Detailed Description
On each visit, participants will undergo a clinical examination with MRC sum score, a mISS score and a I-RODS score.
They will perform few tests 6-minutes walk test (6MWT), a myogrip measurement, and a 9 Hole Peg Test (9HPT) and will answer to some questionaires (mISS, INCAT and PGIC).
Actimyo is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Diagnosed with CIDP or possible CIDP based on 2021 EAN/PNS criteria2.
- Treated with IVIg (≤1g/kg/3-8week)
- Clinically Stable disease for 3 months (according to treating physician opinion).
- No treatment withdrawal failure within 1 year
- Age over 18 years
- Significant cognitive or communication disorders
- Surgery or serious traumatic injury ≤ 6 months
- Non ambulant patient
- Current participation to a therapeutic trial
- Anti-myeline antibodies (anti-MAG) positive or nodo-paranodopathy
- Other autoimmune disease that requires Corticosteroids, IVIg, Plasma Exchange treatment
- Pregnancy or breastfeeding
- Any other condition that, according to the investigator, could significantly interfere with patient evaluation or safety.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 95th centile of stride velocity 1 year 95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo) in real-life (meter per second).
50th centile of stride length 1 year 50th centile of stride length obtained with a magneto-inertial sensor (Actimyo) in real-life (meter).
50th centile of stride velocity 1 year 50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo) in real-life (meter per second).
95th centile of stride length 1 year 95th centile of stride length obtained with a magneto-inertial sensor (Actimyo) in real-life (meter).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHR Citadelle
🇧🇪Liège, Belgium