search
Back to results

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Withdrawn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
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 21, 2020
    Last Updated
    June 29, 2022
    Sponsor
    Fondation Hôpital Saint-Joseph
    search

    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:
    PubMed Identifier
    19564582
    Citation
    Laughlin RS, Dyck PJ, Melton LJ 3rd, Leibson C, Ransom J, Dyck PJ. Incidence and prevalence of CIDP and the association of diabetes mellitus. Neurology. 2009 Jul 7;73(1):39-45. doi: 10.1212/WNL.0b013e3181aaea47.
    Results Reference
    result
    PubMed Identifier
    7041788
    Citation
    Dyck PJ, O'Brien PC, Oviatt KF, Dinapoli RP, Daube JR, Bartleson JD, Mokri B, Swift T, Low PA, Windebank AJ. Prednisone improves chronic inflammatory demyelinating polyradiculoneuropathy more than no treatment. Ann Neurol. 1982 Feb;11(2):136-41. doi: 10.1002/ana.410110205.
    Results Reference
    result
    PubMed Identifier
    24379104
    Citation
    Eftimov F, Winer JB, Vermeulen M, de Haan R, van Schaik IN. Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2013 Dec 30;(12):CD001797. doi: 10.1002/14651858.CD001797.pub3.
    Results Reference
    result
    PubMed Identifier
    20456730
    Citation
    Van den Bergh PY, Hadden RD, Bouche P, Cornblath DR, Hahn A, Illa I, Koski CL, Leger JM, Nobile-Orazio E, Pollard J, Sommer C, van Doorn PA, van Schaik IN; European Federation of Neurological Societies; Peripheral Nerve Society. European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy: report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society - first revision. Eur J Neurol. 2010 Mar;17(3):356-63. doi: 10.1111/j.1468-1331.2009.02930.x. Erratum In: Eur J Neurol. 2011 May;18(5):796.
    Results Reference
    result
    PubMed Identifier
    27241239
    Citation
    Adrichem ME, Eftimov F, van Schaik IN. Intravenous immunoglobulin treatment in chronic inflammatory demyelinating polyradiculoneuropathy, a time to start and a time to stop. J Peripher Nerv Syst. 2016 Sep;21(3):121-7. doi: 10.1111/jns.12176.
    Results Reference
    result
    PubMed Identifier
    18178525
    Citation
    Hughes RA, Donofrio P, Bril V, Dalakas MC, Deng C, Hanna K, Hartung HP, Latov N, Merkies IS, van Doorn PA; ICE Study Group. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomised placebo-controlled trial. Lancet Neurol. 2008 Feb;7(2):136-44. doi: 10.1016/S1474-4422(07)70329-0. Erratum In: Lancet Neurol. 2008 Sep;7(9):771.
    Results Reference
    result
    PubMed Identifier
    19496628
    Citation
    Kuitwaard K, van Doorn PA. Newer therapeutic options for chronic inflammatory demyelinating polyradiculoneuropathy. Drugs. 2009 May 29;69(8):987-1001. doi: 10.2165/00003495-200969080-00004.
    Results Reference
    result
    PubMed Identifier
    27918219
    Citation
    Debs R, Reach P, Cret C, Demeret S, Saheb S, Maisonobe T, Viala K. A new treatment regimen with high-dose and fractioned immunoglobulin in a special subgroup of severe and dependent CIDP patients. Int J Neurosci. 2017 Oct;127(10):864-872. doi: 10.1080/00207454.2016.1269328. Epub 2016 Dec 20.
    Results Reference
    result
    PubMed Identifier
    30463240
    Citation
    Oudre L, Barrois-Muller R, Moreau T, Truong C, Vienne-Jumeau A, Ricard D, Vayatis N, Vidal PP. Template-Based Step Detection with Inertial Measurement Units. Sensors (Basel). 2018 Nov 19;18(11):4033. doi: 10.3390/s18114033.
    Results Reference
    result
    PubMed Identifier
    16365632
    Citation
    Antoine JC, Azulay JP, Bouche P, Creange A, Fournier E, Gallouedec G, Lagueny A, Lefaucheur JP, Leger JM, Magy L, Maisonobe T, Nicolas G, Pouget J, Soichot P, Stojkovic T, Vallat JM, Verschueren A, Vial C, Viala K; Groupe d'Etude francais des PIDC. [Chronic inflammatory demyelinating polyradiculoneuropathy: diagnostic strategy. Guidelines of the French CIDP study group]. Rev Neurol (Paris). 2005 Oct;161(10):988-96. doi: 10.1016/s0035-3787(05)85166-5. French.
    Results Reference
    result
    PubMed Identifier
    28572784
    Citation
    Vienne A, Barrois RP, Buffat S, Ricard D, Vidal PP. Inertial Sensors to Assess Gait Quality in Patients with Neurological Disorders: A Systematic Review of Technical and Analytical Challenges. Front Psychol. 2017 May 18;8:817. doi: 10.3389/fpsyg.2017.00817. eCollection 2017.
    Results Reference
    result
    PubMed Identifier
    32373047
    Citation
    Vienne-Jumeau A, Oudre L, Moreau A, Quijoux F, Edmond S, Dandrieux M, Legendre E, Vidal PP, Ricard D. Personalized Template-Based Step Detection From Inertial Measurement Units Signals in Multiple Sclerosis. Front Neurol. 2020 Apr 21;11:261. doi: 10.3389/fneur.2020.00261. eCollection 2020.
    Results Reference
    result
    PubMed Identifier
    9208265
    Citation
    Andersen H, Jakobsen J. A comparative study of isokinetic dynamometry and manual muscle testing of ankle dorsal and plantar flexors and knee extensors and flexors. Eur Neurol. 1997;37(4):239-42. doi: 10.1159/000117450.
    Results Reference
    result
    PubMed Identifier
    16293415
    Citation
    Rao S, Saltzman C, Yack HJ. Ankle ROM and stiffness measured at rest and during gait in individuals with and without diabetic sensory neuropathy. Gait Posture. 2006 Nov;24(3):295-301. doi: 10.1016/j.gaitpost.2005.10.004. Epub 2005 Nov 15.
    Results Reference
    result

    Learn more about this trial

    InertiaLocoGraphy as a Biomarker of Immunoglobulin Therapy Efficacy in Chronic Inflammatory Demyelinating Polyradiculoneuropathy

    We'll reach out to this number within 24 hrs