Exploratory Study on Predicting CIDP Patients' Decline During IV Immunoglobulin Treatment Adaptation Feasibility.
NCT ID: NCT06183645
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2023-08-28
2028-01-31
Brief Summary
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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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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
99 Years
ALL
No
Sponsors
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SYSNAV
INDUSTRY
Centre Hospitalier Régional de la Citadelle
OTHER
Centre Hospitalier Universitaire de Liege
OTHER
Responsible Party
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Stéphanie DELSTANCHE
Coordinator of reference center for neuromuscular diseases
Principal Investigators
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Margaux Poleur, Dr
Role: PRINCIPAL_INVESTIGATOR
CHR Citadelle
Locations
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CHR Citadelle
Liège, Liège, Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ActiCIDP
Identifier Type: -
Identifier Source: org_study_id
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