Exploratory Study on Predicting CIDP Patients' Decline During IV Immunoglobulin Treatment Adaptation Feasibility. (ActiCIDP)

ActiCIDP : Exploratory Study on the Feasibility of Predicting CIDP Patients' Evolution Decline During Intravenous Immunoglobulins Treatment Adaptation.

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Inflammatory Demyelinating Polyneuropathy
• Intervention / Treatment: Device: Actimyo

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Margaux Poleur, Dr; Phone Number: +32 04216127; Email: margaux.poleur@citadelle.be
• Study Contact Backup: Name: Laurie Medard; Phone Number: +32 043215584; Email: laurie.medard@citadelle.be

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Recruiting
    • CHR Citadelle
    • Contact: Laurie MEDARD; Phone Number: 0032 43218222; Email: Laurie.Medard@citadelle.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults patients with Chronic inflammatory demyelinating polyradiculoneuritis

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
95th centile of stride velocity	95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo) in real-life (meter per second).	1 year
50th centile of stride velocity	50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo) in real-life (meter per second).	1 year
95th centile of stride length	95th centile of stride length obtained with a magneto-inertial sensor (Actimyo) in real-life (meter).	1 year
50th centile of stride length	50th centile of stride length obtained with a magneto-inertial sensor (Actimyo) in real-life (meter).	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Liege
• Collaborators: Centre Hospitalier Régional de la Citadelle; SYSNAV
• Investigators: Principal Investigator: Margaux Poleur, Dr, CHR Citadelle

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Accelerometry; Actimyo; Daily living
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyradiculoneuropathy; Polyneuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
• Other Study ID Numbers: ActiCIDP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No