Clinical trial NCT06183645: Exploratory Study on Predicting CIDP Patients' Decline During IV Immunoglobulin Treatment Adaptation Feasibility.
Official title: ActiCIDP : Exploratory Study on the Feasibility of Predicting CIDP Patients' Evolution Decline During Intravenous Immunoglobulins Treatment Adaptation.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy
Keywords: Actimyo
Accelerometry
Daily living
Lead sponsor: Centre Hospitalier Universitaire de Liege
Sponsor class: OTHER
Collaborators: name: SYSNAV
name: Centre Hospitalier Régional de la Citadelle
First posted: 2023-12-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients with Chronic inflammatory demyelinating polyradiculoneuritis

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 95th centile of stride velocity
timeFrame: 1 year
measure: 50th centile of stride velocity
timeFrame: 1 year
measure: 95th centile of stride length
timeFrame: 1 year
measure: 50th centile of stride length
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHR Citadelle
Study officials:
affiliation: CHR Citadelle
name: Margaux Poleur, Dr
role: PRINCIPAL_INVESTIGATOR
References: