Chronic Inflammatory Demyelinating PolyneuropathyActiCIDPNCT06183645
Exploratory Study on Predicting CIDP Patients' Decline During IV Immunoglobulin Treatment Adaptation Feasibility.
An observational study of Chronic Inflammatory Demyelinating Polyneuropathy, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy
- What is being tested?
- Actimyo
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Aug 2023to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients with Chronic inflammatory demyelinating polyradiculoneuritis
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
CHR Citadelle
Liège, Liège, 4000
Laurie Medard, 43218222 ext. 0032, Laurie.Medard@citadelle.be
About this study
Official title: ActiCIDP : Exploratory Study on the Feasibility of Predicting CIDP Patients' Evolution Decline During Intravenous Immunoglobulins Treatment Adaptation.
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.
Read the 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.
- Being tested
- Actimyo
- Keywords
- Actimyo, Accelerometry, Daily living
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActimyoDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
95th centile of stride velocity
95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo) in real-life (meter per second).
Measured: 1 year
50th centile of stride velocity
50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo) in real-life (meter per second).
Measured: 1 year
95th centile of stride length
95th centile of stride length obtained with a magneto-inertial sensor (Actimyo) in real-life (meter).
Measured: 1 year
50th centile of stride length
50th centile of stride length obtained with a magneto-inertial sensor (Actimyo) in real-life (meter).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start28 Aug 2023
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Collaborators
- SYSNAV, Centre Hospitalier Régional de la Citadelle
- Responsible party
- Principal investigator, Stéphanie DELSTANCHE, Centre Hospitalier Universitaire de Liege
- Investigators
- Margaux Poleur, Dr, Principal investigator, CHR Citadelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183645
- Sponsor's protocol ID
- ActiCIDP
- Acronym
- ActiCIDP
- Status last verified
- Feb 2025
- First submitted
- 14 Dec 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ActiCIDP : Exploratory Study on the Feasibility of Predicting CIDP Patients' Evolution Decline During Intravenous Immunoglobulins Treatment Adaptation.
- ClinicalTrials.gov ID
- NCT06183645
- Acronym / sponsor ID
- ActiCIDP / ActiCIDP
- Keywords
- Actimyo, Accelerometry, Daily living
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Collaborators
- SYSNAV, Centre Hospitalier Régional de la Citadelle
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients with Chronic inflammatory demyelinating polyradiculoneuritis
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActimyoParticipants 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. | Device | – |
Primary outcome
95th centile of stride velocity
Time frame: 1 year
95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo) in real-life (meter per second).
50th centile of stride velocity
Time frame: 1 year
50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo) in real-life (meter per second).
95th centile of stride length
Time frame: 1 year
95th centile of stride length obtained with a magneto-inertial sensor (Actimyo) in real-life (meter).
50th centile of stride length
Time frame: 1 year
50th centile of stride length obtained with a magneto-inertial sensor (Actimyo) in real-life (meter).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margaux Poleur, Dr principal investigator
CHR Citadelle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Inflammatory Demyelinating Polyneuropathy, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurie Medard (043215584 ext. +32, laurie.medard@citadelle.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
95th centile of stride velocity (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025; AzTrials last refreshed its copy on 29 Oct 2026.