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

Chronic Inflammatory Demyelinating Polyneuropathy Clinical Trial

— ActiCIDP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06183645
• Other study ID #: ActiCIDP
• Status: Recruiting
• Start date: August 28, 2023
• Est. completion date: January 2028

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Liege
• Contact: Laura Buscemi
• Phone: 043215584
• Email: laura.buscemi[@]citadelle.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Inflammatory Demyelinating Polyneuropathy
• Polyneuropathies
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Belgium	CHR Citadelle	Liège

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Liege	Centre Hospitalier Régional de la Citadelle, SYSNAV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	95th centile of stride velocity	95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo) in real-life (meter per second).	1 year
Primary	50th centile of stride velocity	50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo) in real-life (meter per second).	1 year
Primary	95th centile of stride length	95th centile of stride length obtained with a magneto-inertial sensor (Actimyo) in real-life (meter).	1 year
Primary	50th centile of stride length	50th centile of stride length obtained with a magneto-inertial sensor (Actimyo) in real-life (meter).	1 year