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

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Brief Title

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

Official Title

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

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.
    



Study Type

Interventional


Primary Outcome

Push-off Variation between D1 and D15

Secondary Outcome

 Push-off Variation at Day 4

Condition

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Intervention

Group with walking disorder

Study Arms / Comparison Groups

 Group with walking disorder
Description:  This Group with walking disorder corresponds to patient reporting walking disorders due to his illness.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

20

Start Date

April 16, 2022

Completion Date

December 31, 2023

Primary Completion Date

December 31, 2023

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pauline REACH, MD, 0144126230, [email protected]



Administrative Informations


NCT ID

NCT04529291

Organization ID

SW_CIDP


Responsible Party

Sponsor

Study Sponsor

Groupe Hospitalier Paris Saint Joseph


Study Sponsor

Pauline REACH, MD, Principal Investigator, Groupe Hospitalier Paris Saint Joseph


Verification Date

January 2022