Exploratory Study on Predicting CIDP Patients' Decline During IV Immunoglobulin Treatment Adaptation Feasibility.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Actimyo.
- Who it may be relevant to
- Registry conditions: Chronic Inflammatory Demyelinating Polyneuropathy. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ActiCIDP : Exploratory Study on the Feasibility of Predicting CIDP Patients' Evolution Decline During Intravenous Immunoglobulins Treatment Adaptation.
Overview
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.
Interventions
- Device Actimyo
Participants will wear 2 Actimyos in everyday life. 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.
Primary outcome measures
- 95th centile of stride velocity [Time frame: 1 year]
- 50th centile of stride velocity [Time frame: 1 year]
- 95th centile of stride length [Time frame: 1 year]
- 50th centile of stride length [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Belgium · 1 center
- CHR Citadelle — Liège
Identifiers
NCT: NCT06183645 · ActiCIDP