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

Last updated: February 10, 2025
Sponsor: Centre Hospitalier Universitaire de Liege
Overall Status: Active - Recruiting

Phase

N/A

Condition

Peripheral Neuropathy

Treatment

Actimyo

Clinical Study ID

NCT06183645
ActiCIDP
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 Exchangetreatment

  • Pregnancy or breastfeeding

  • Any other condition that, according to the investigator, could significantlyinterfere with patient evaluation or safety.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Actimyo
Phase:
Study Start date:
August 28, 2023
Estimated Completion Date:
January 31, 2028

Study 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.

Connect with a study center

  • CHR Citadelle

    Liège, 4000
    Belgium

    Active - Recruiting

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