InertiaLocoGraphy as a Biomarker of Immunoglobulin Therapy Efficacy in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (SW_CIDP)
Primary Purpose
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group with walking disorder
Group without walking disorder
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Eligibility Criteria
Inclusion Criteria:
- Patient whose age is ≥ 18 years
Patient diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP) in one of the following two cases:
- Certain IPDC according to ENFS / PNS 2010 criteria
- Possible or probable CIDP according to ENFS / PNS 2010 criteria with favorable response to immunomodulatory treatment 23
- Patient treated with IVIG
- Mobile patient, able to walk 2 sets of 20 m with a half turn, with a 3 min break between the two exercises.
Patients will be included in one of the following two groups:
- G_CIDP: if the patient reports walking disorders due to his illness
NG_CIDP: otherwise
- Patient living in an area accessible by public transport with a journey time of 1 hour (sector ≈ 5 - 6 km)
- Patient affiliated to a social security scheme
- Patient who has given oral, free, informed and express consent
Exclusion Criteria:
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Pregnant woman
- Patient with a pathology other than IPDC that may affect walking (muscular-skeletal pathology, other neurological pathology, etc.) according to the attached clinical questionnaire
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group with walking disorder
Group without walking disorder
Arm Description
This Group with walking disorder corresponds to patient reporting walking disorders due to his illness.
This Group without walking disorder corresponds to patients not reporting walking disorders due to his illness.
Outcomes
Primary Outcome Measures
Push-off Variation between D1 and D15
This outcome corresponds to comparison of the absolute variation of Push-off (corresponding to the power of the moment of propulsion at the ankle during the last moments of the support phase) between D0 and D15 in the three subgroups defined by the change in ONLS at D15.
Secondary Outcome Measures
Push-off Variation at Day 4
This outcome corresponds to comparison of the absolute variation of Push-off (corresponding to the power of the moment of propulsion at the ankle during the last moments of the support phase) between D0 and D4 in the three subgroups defined by the change in ONLS.
Walking speed Variation at Day 4
This outcome corresponds to comparison of the absolute variation of the walking speed and the quality criteria of walking (vigor of the step, rhythmicity, regularity, symmetry, stability, fluidity, synchronization) between D0 and D4 in the three sub-groups defined by the change in ONLS on D15 (Subgroups: responders if ONLS decrease by more than 1 point, non-responder if ONLS is stable, progressors if ONLS increase by more than 1 point) in groups of patients with and without walking disorders
Walking speed Variation at Day 15
This outcome corresponds to comparison of the absolute variation of the walking speed and the quality criteria of walking (vigor of the step, rhythmicity, regularity, symmetry, stability, fluidity, synchronization) between D0 and D15 in the three sub-groups defined by the change in ONLS on D15 (Subgroups: responders if ONLS decrease by more than 1 point, non-responder if ONLS is stable, progressors if ONLS increase by more than 1 point) in groups of patients with and without walking disorders
Full Information
NCT ID
NCT04529291
First Posted
August 21, 2020
Last Updated
June 29, 2022
Sponsor
Fondation Hôpital Saint-Joseph
1. Study Identification
Unique Protocol Identification Number
NCT04529291
Brief Title
InertiaLocoGraphy as a Biomarker of Immunoglobulin Therapy Efficacy in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Acronym
SW_CIDP
Official Title
InertiaLocoGraphy as a Biomarker of Immunoglobulin Therapy Efficacy in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The IP decided to stop.
Study Start Date
April 16, 2022 (Actual)
Primary Completion Date
April 16, 2022 (Actual)
Study Completion Date
April 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic inflammatory demyelinating polyradiculoneuropathy is a diffuse multifocal autoimmune disorder of the peripheral neuron, affecting 1 to 9 in 100,000 people. Its course is difficult to predict, and may be characterized by continuous progression, multiple relapses, or recovery after a few months. treatment. The predominantly motor form with 4 limbs represents the typical form, but the disease can take on other clinical forms (pure sensory impairment, ataxia, etc.).
In addition to induction therapy, patients most often require long-term maintenance therapy. First-line therapies, with the same efficacy according to a 2013 Cochrane study, are glucocorticoid therapy, plasma exchanges and intravenous immunoglobulin injections. Glucocorticoids have a grade C recommendation level while a grade A has been assigned to intravenous immunoglobulins and plasma exchange. However, the latter have less tolerance and have a rebound effect which limits their long-term interest. Intravenous immunoglobulins are therefore the preferred treatment today. The effect of intravenous immunoglobulins, delivered as a bolus over a few days, lasts two to six weeks, with the number of people being cured of three to improve a person. A more recent study has also shown their advantage in reducing the relapse rate at 6 months.
However, the response to intravenous immunoglobulins fluctuates in different patients and, for any given patient, changes over the course of the disease. The 2010 recommendations therefore recommend an adaptation of the doses and duration of intercourse (0.4 to 1.2 g / kg every 2 to 6 weeks) according to individual monitoring of the response to treatment. In order to embrace the diversity of symptoms of chronic inflammatory demyelinating polyradiculoneuropathy, several scores and scales are usually combined to ensure this follow-up in a cohort. Three clinical data are currently favored: the Inflammatory Rasch-built Overall Disability Scale (I-RODS), the INCAT Overall Neuropathy Limitations Scale (ONLS), the score of the Medical Research Council (MRC). However, none of them assess walking objectively.
However, patients with chronic inflammatory demyelinating polyradiculoneuropathy sometimes report significant walking disturbances, which may result from both sensory disturbances or motor disturbances present in varying degrees depending on the patient. The alterations concerned, according to the studies, the walking speed, the temporal pattern of the step, with an impairment of the durations of the different phases (support and oscillation) or the angle and the angular speed of roll at the level of the trunk. Alterations in speed and phase duration of the step improve during treatment with intravenous immunoglobulin cures, with greater sensitivity compared to the ONLS and MRC scales. The power of the propulsive moment at the ankle during the last moments of the stance phase - the push-off - is another promising gait parameter that has made it possible to distinguish diabetic patients with polyneuropathy from those without diabetes. polyneuropathy and the intensity of the deficit is linked to the severity of the attack. Gait speed, as a reflection of the subject's gait performance, and the quality of gait including the timing of gait, trunk rotation movements and push-off, therefore seem to be potential response markers. for monitoring patients treated with intravenous immunoglobulins.
InertiaLocoGraphy, quantification of gait by inertial measurement sensors, has proven its value in the evaluation of various pathologies in neurological practice, including chronic inflammatory demyelinating polyradiculoneuropathy. It gives access to the walking speed as well as to various walking quality criteria (vigor of the step, rhythmicity, regularity, symmetry, stability, fluidity, synchronization) including the times of the different walking phases and the rotational movements of the trunk, and a push-off substitute.
InertiaLocoGraphie, non-invasive, easy and quick to set up, reflecting the patient's function, therefore potentially provides biomarkers of choice for monitoring the response to intravenous immunoglobulin cures in patients with chronic inflammatory polyradiculoneuropathy demyelinating. Its association with the traditional monitoring tools such as the ONLS score, the I-ROS, and the CRM therefore appears to be of key interest for this monitoring.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group with walking disorder
Arm Type
Other
Arm Description
This Group with walking disorder corresponds to patient reporting walking disorders due to his illness.
Arm Title
Group without walking disorder
Arm Type
Other
Arm Description
This Group without walking disorder corresponds to patients not reporting walking disorders due to his illness.
Intervention Type
Other
Intervention Name(s)
Group with walking disorder
Intervention Description
During the patient's hospitalization, two questionnaires will be completed, assessing the handicap of the patient in his daily activities, and the specific incapacity to carry out activities of daily living and social life (10 minutes to complete). The patient will then carry out two 20-meter round-trip walking tests during his first day and his last day of care at the hospital. Additional home visits, corresponding to intervention, performed by a member of the investigative team, will take place once a week (15-20 minutes). The team will collect his feelings about the evolution of symptoms through the two questionnaires, and quantify the evolution of his walking. Walk tests are recorded using small inertial sensors (accelerometers and gyrometers) that will be placed at his feet, belt and forehead. This examination is not painful. All the measurements are carried out in 15 minutes by a member of the team.
Intervention Type
Other
Intervention Name(s)
Group without walking disorder
Intervention Description
During the patient's hospitalization, two questionnaires will be completed, assessing the handicap of the patient in his daily activities, and the specific incapacity to carry out activities of daily living and social life (10 minutes to complete). The patient will then carry out two 20-meter round-trip walking tests during his first day and his last day of care at the hospital.
Additional home visits, corresponding to interventions, performed by a member of the investigative team, will take place once a week (15-20 minutes). The team will collect his feelings about the evolution of symptoms through the two questionnaires, and quantify the evolution of his walking. Walk tests are recorded using small inertial sensors (accelerometers and gyrometers) that will be placed at his feet, belt and forehead. This examination is not painful. All the measurements are carried out in 15 minutes by a member of the team.
Primary Outcome Measure Information:
Title
Push-off Variation between D1 and D15
Description
This outcome corresponds to comparison of the absolute variation of Push-off (corresponding to the power of the moment of propulsion at the ankle during the last moments of the support phase) between D0 and D15 in the three subgroups defined by the change in ONLS at D15.
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Push-off Variation at Day 4
Description
This outcome corresponds to comparison of the absolute variation of Push-off (corresponding to the power of the moment of propulsion at the ankle during the last moments of the support phase) between D0 and D4 in the three subgroups defined by the change in ONLS.
Time Frame
Day 4
Title
Walking speed Variation at Day 4
Description
This outcome corresponds to comparison of the absolute variation of the walking speed and the quality criteria of walking (vigor of the step, rhythmicity, regularity, symmetry, stability, fluidity, synchronization) between D0 and D4 in the three sub-groups defined by the change in ONLS on D15 (Subgroups: responders if ONLS decrease by more than 1 point, non-responder if ONLS is stable, progressors if ONLS increase by more than 1 point) in groups of patients with and without walking disorders
Time Frame
Day 4
Title
Walking speed Variation at Day 15
Description
This outcome corresponds to comparison of the absolute variation of the walking speed and the quality criteria of walking (vigor of the step, rhythmicity, regularity, symmetry, stability, fluidity, synchronization) between D0 and D15 in the three sub-groups defined by the change in ONLS on D15 (Subgroups: responders if ONLS decrease by more than 1 point, non-responder if ONLS is stable, progressors if ONLS increase by more than 1 point) in groups of patients with and without walking disorders
Time Frame
Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient whose age is ≥ 18 years
Patient diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP) in one of the following two cases:
Certain IPDC according to ENFS / PNS 2010 criteria
Possible or probable CIDP according to ENFS / PNS 2010 criteria with favorable response to immunomodulatory treatment 23
Patient treated with IVIG
Mobile patient, able to walk 2 sets of 20 m with a half turn, with a 3 min break between the two exercises.
Patients will be included in one of the following two groups:
G_CIDP: if the patient reports walking disorders due to his illness
NG_CIDP: otherwise
Patient living in an area accessible by public transport with a journey time of 1 hour (sector ≈ 5 - 6 km)
Patient affiliated to a social security scheme
Patient who has given oral, free, informed and express consent
Exclusion Criteria:
Patient under guardianship or curatorship
Patient deprived of liberty
Pregnant woman
Patient with a pathology other than IPDC that may affect walking (muscular-skeletal pathology, other neurological pathology, etc.) according to the attached clinical questionnaire
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline REACH, MD
Organizational Affiliation
Fondation Hôpital Saint-Joseph
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
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InertiaLocoGraphy as a Biomarker of Immunoglobulin Therapy Efficacy in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
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