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

NCT06183645 | Recruiting

• 1 other identifier: ActiCIDP
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

Actimyo; Accelerometry; Daily living

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Actimyo DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults patients with Chronic inflammatory demyelinating polyradiculoneuritis

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Liege: lead
• SYSNAV: collaborator
• Centre Hospitalier Régional de la Citadelle: collaborator

Study Sites (1)

CHR Citadelle

Liège, Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Margaux Poleur, Dr

  CHR Citadelle

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurie Medard

CONTACT

043215584; laurie.medard@citadelle.be

Margaux Poleur, Dr

CONTACT

04216127; margaux.poleur@citadelle.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of reference center for neuromuscular diseases

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 27, 2023
• Study Start: August 28, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)