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

U

University Hospital Center (CHU) of Liege

Status

Enrolling

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Treatments

Device: Actimyo

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT06183645
ActiCIDP

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

Margaux Poleur, Dr; Laurie Medard

Data sourced from clinicaltrials.gov

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