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NCT Number: NCT06183645

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

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR Citadelle

Liège, 4000, Belgium

Location status: Recruiting

Location contact

Laurie Medard

CONTACT

[email protected]

43218222 ext. 0032

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 95th centile of stride velocity

    Time frame: 1 year

    95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo) in real-life (meter per second).

  2. 50th centile of stride velocity

    Time frame: 1 year

    50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo) in real-life (meter per second).

  3. 95th centile of stride length

    Time frame: 1 year

    95th centile of stride length obtained with a magneto-inertial sensor (Actimyo) in real-life (meter).

  4. 50th centile of stride length

    Time frame: 1 year

    50th centile of stride length obtained with a magneto-inertial sensor (Actimyo) in real-life (meter).

Study contacts

Contact information is provided by the study sponsor or research team.

Laurie Medard

CONTACT

[email protected]

043215584 ext. +32

Margaux Poleur, Dr

CONTACT

[email protected]

04216127 ext. +32

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Liege

Other

Collaborators

  • Centre Hospitalier Régional de la Citadelle
  • SYSNAV

Registry information

Official study title

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

Acronym: ActiCIDP

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Dec 27, 2023
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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