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

NCT ID: NCT06183645

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-28

Study Completion Date

2028-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Inflammatory Demyelinating Polyneuropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

SYSNAV

INDUSTRY

Sponsor Role collaborator

Centre Hospitalier Régional de la Citadelle

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Liege

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stéphanie DELSTANCHE

Coordinator of reference center for neuromuscular diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Margaux Poleur, Dr

Role: PRINCIPAL_INVESTIGATOR

CHR Citadelle

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHR Citadelle

Liège, Liège, Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Laurie Medard

Role: CONTACT

043215584 ext. +32

Margaux Poleur, Dr

Role: CONTACT

04216127 ext. +32

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Laurie Medard

Role: primary

43218222 ext. 0032

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ActiCIDP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

IVIG vs SCIG in CIDP
NCT05584631 RECRUITING PHASE1