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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06183645
Acronym
ActiCIDP
Enrollment
40
Registered
2023-12-27
Start date
2023-08-28
Completion date
2028-01-31
Last updated
2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

Actimyo, Accelerometry, Daily living

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.

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.

Interventions

DEVICEActimyo

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.

Sponsors

SYSNAV
CollaboratorINDUSTRY
Centre Hospitalier Régional de la Citadelle
CollaboratorOTHER
Centre Hospitalier Universitaire de Liege
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
95th centile of stride velocity1 year95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo) in real-life (meter per second).
50th centile of stride velocity1 year50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo) in real-life (meter per second).
95th centile of stride length1 year95th centile of stride length obtained with a magneto-inertial sensor (Actimyo) in real-life (meter).
50th centile of stride length1 year50th centile of stride length obtained with a magneto-inertial sensor (Actimyo) in real-life (meter).

Countries

Belgium

Contacts

Primary ContactLaurie Medard
laurie.medard@citadelle.be043215584
Backup ContactMargaux Poleur, Dr
margaux.poleur@citadelle.be04216127

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026