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Pathophysiology of Gait and Posture in Progressive Supranuclear Palsy (Gait-PSP)

Primary Purpose

Progressive Supranuclear Palsy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
gait recordings
brain magnetic resonance imaging
oculomotor movement recordings
Sponsored by
Centre Hospitalier Universitaire de Pointe-a-Pitre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Progressive Supranuclear Palsy focused on measuring progressive supranuclear palsy PSP, atypical parkinsonism, gait disorders, neurophysiology, imaging

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient :
  • Patients who met the clinical criteria for PSP and Gd-PSP
  • Walking and standing alone without assistance
  • Patient or responsible third party who received information about the study and who signed the informed consent
  • French
  • Patients over 40 years
  • Clinically detectable eye movement anomaly

Witnesses :

  • To be affiliated or beneficiary of social security scheme
  • French person
  • Major subjects, matched for age (± 3 years) and sex, showing no neurological or psychiatric disease or severe progressive disease
  • No Indication against MRI

Exclusion Criteria:

Patient :

  • Patient not affiliated with the social security system
  • Cognitive impairment: MMSE ≤ 20; FAB ≤ 12
  • psychiatric disorders likely to interfere with exploration; severe postural disorders
  • MRI not feasible Witnesses
  • Not affiliated or benificiary of social security scheme
  • Not a french person
  • Somebody showing neurological or psychiatric disease or severe progressive disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    PSP Classic

    Caribbean PSP

    Healthy controls

    Arm Description

    15 patients with a "classical" form of PSP are recruited to realize all the tests of the multimodal approach.

    15 patients with a "Caribbean PSP" are recruited to realize all the tests of the multimodal approach.

    15 persons with no PSP are recruited to realize all the tests of the multimodal approach.

    Outcomes

    Primary Outcome Measures

    gait velocity
    gait recordings

    Secondary Outcome Measures

    brain anatomy
    magnetic resonance imaging
    oculomotor movements recordings
    oculomotor movements recordings

    Full Information

    First Posted
    September 6, 2019
    Last Updated
    September 17, 2019
    Sponsor
    Centre Hospitalier Universitaire de Pointe-a-Pitre
    Collaborators
    University Hospital Center of Martinique, Groupe Hospitalier Pitie-Salpetriere
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04096651
    Brief Title
    Pathophysiology of Gait and Posture in Progressive Supranuclear Palsy
    Acronym
    Gait-PSP
    Official Title
    Pathophysiology of Gait and Posture in Progressive Supranuclear Palsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 28, 2015 (Actual)
    Primary Completion Date
    July 12, 2018 (Actual)
    Study Completion Date
    July 12, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Pointe-a-Pitre
    Collaborators
    University Hospital Center of Martinique, Groupe Hospitalier Pitie-Salpetriere

    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
    The main hypothesis is that the gait and postural deficits in the Caribbean form of PSP may be associated with a dysfunction of the cerebral cortex, as they result from sub-cortical involvement in classical forms. The investigators will characterize the gait and posture with a force platform to collect biomechanical gait parameters, coupled with the kinematic and electromyographic (EMG) study. Then the investigators realize a multimodal imaging study [structural magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI)] that allow us to determine if a correlation can be found between the clinical characteristics of postural control and walking on one hand, and morphological changes and structural MRI changes in cortico-subcortical pathways on the other hand. The study of performance on neuropsychological tests, registration of ocular movements and the analysis of functional cortical activity will complete our multimodal approach. A better understanding of these disorders is expected to propose new drug treatment and rehabilitative strategies.
    Detailed Description
    Progressive supranuclear palsy (PSP) is a rare neurodegenerative disease (6/100 000 inhabitants) characterized by the association of Parkinson's syndrome, a paralysis of the verticality of the gaze and an alteration early balance and walking with the onset of falls during the first year of evolution of the disease. From a neuropathological point of view, it is characterized by a tauopathy with neurodegeneration within the basal ganglia, cerebellum, and midbrain (which includes the mesencephalic locomotor region-MLR). In the Caribs this pathology is abnormally frequent (incidence over 3 times higher than expected), and represents 1/3 of the total Parkinsonian syndromes. In these patients, cortical pathology predominates leading to different cognitive deficit relative to patients with the classical form of PSP. Conversely, in PSP patients, imaging data suggest a preferential midbrain-thalamocortical pathway dysfunction. Pathophysiological mechanisms causing gait disturbances and postural control presented by these patients remains however not fully elucidated . In patients with Caribbean PSP, of which the clinical features are specific, gait disorders and falls appear later in the course of the disease (2.5 years on average) suggesting perhaps a different physiopathological mechanism. Consequently weak knowledge of the mechanisms involved, none specific treatment is currently available and the taking in therapeutic charge of these disorders rests essentially on a re-educative approach that remains poorly codified. In this study, gait and balance disorders will be recorded using a force platform, coupled with kinematic study and EMG in patients with classical form of PSP and Caribbean one, and in controls. The functional and anatomy of brain will be examined using a multimodal brain imaging approach (with DTI. Performance in neuropsychological tests and oculomotor movements will also be measured. A comparative and correlation analyses will be performed to assess the link between gait, balance, oculomotor and cognitive performances and brain anatomy, and the differences between subjects groups. Caribbean PSP patients are recruited from Neurology and Physical Medicine and Rehabilitation of University Hospital of Pointe-à-Pitre and Fort de France, Classical PSP patients are be recruited from the Centre d'Investigation Clinique (CIC) of the Pitié-Salpêtrière hospital, and healthy volunteers from both centers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Progressive Supranuclear Palsy
    Keywords
    progressive supranuclear palsy PSP, atypical parkinsonism, gait disorders, neurophysiology, imaging

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PSP Classic
    Arm Type
    Other
    Arm Description
    15 patients with a "classical" form of PSP are recruited to realize all the tests of the multimodal approach.
    Arm Title
    Caribbean PSP
    Arm Type
    Other
    Arm Description
    15 patients with a "Caribbean PSP" are recruited to realize all the tests of the multimodal approach.
    Arm Title
    Healthy controls
    Arm Type
    Other
    Arm Description
    15 persons with no PSP are recruited to realize all the tests of the multimodal approach.
    Intervention Type
    Other
    Intervention Name(s)
    gait recordings
    Intervention Description
    gait recordings
    Intervention Type
    Other
    Intervention Name(s)
    brain magnetic resonance imaging
    Intervention Description
    brain magnetic resonance imaging
    Intervention Type
    Other
    Intervention Name(s)
    oculomotor movement recordings
    Intervention Description
    oculomotor movement recordings
    Primary Outcome Measure Information:
    Title
    gait velocity
    Description
    gait recordings
    Time Frame
    at inclusion
    Secondary Outcome Measure Information:
    Title
    brain anatomy
    Description
    magnetic resonance imaging
    Time Frame
    at inclusion
    Title
    oculomotor movements recordings
    Description
    oculomotor movements recordings
    Time Frame
    at inclusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patient : Patients who met the clinical criteria for PSP and Gd-PSP Walking and standing alone without assistance Patient or responsible third party who received information about the study and who signed the informed consent French Patients over 40 years Clinically detectable eye movement anomaly Witnesses : To be affiliated or beneficiary of social security scheme French person Major subjects, matched for age (± 3 years) and sex, showing no neurological or psychiatric disease or severe progressive disease No Indication against MRI Exclusion Criteria: Patient : Patient not affiliated with the social security system Cognitive impairment: MMSE ≤ 20; FAB ≤ 12 psychiatric disorders likely to interfere with exploration; severe postural disorders MRI not feasible Witnesses Not affiliated or benificiary of social security scheme Not a french person Somebody showing neurological or psychiatric disease or severe progressive disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Annie LANNUZEL, PU-PH
    Organizational Affiliation
    University Hospital of Guadeloupe
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Régine EDRAGAS, PH
    Organizational Affiliation
    University Hospital of Martinique
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Marie-Laure WELTER, PU-PH
    Organizational Affiliation
    Groupe Hospitalier Pitie-Salpetriere
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Pathophysiology of Gait and Posture in Progressive Supranuclear Palsy

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