Pathophysiology of Gait and Posture in Progressive Supranuclear Palsy

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Brief Title

Pathophysiology of Gait and Posture in Progressive Supranuclear Palsy

Official Title

Pathophysiology of Gait and Posture in Progressive Supranuclear Palsy

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.
    


Study Type

Interventional


Primary Outcome

gait velocity

Secondary Outcome

 brain anatomy

Condition

Progressive Supranuclear Palsy

Intervention

gait recordings

Study Arms / Comparison Groups

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

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

48

Start Date

September 28, 2015

Completion Date

July 12, 2018

Primary Completion Date

July 12, 2018

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
      

Gender

All

Ages

40 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Annie LANNUZEL, PU-PH, , 



Administrative Informations


NCT ID

NCT04096651

Organization ID

RBM-PAP-2015/19


Responsible Party

Sponsor

Study Sponsor

Centre Hospitalier Universitaire de Pointe-a-Pitre

Collaborators

 University Hospital Center of Martinique

Study Sponsor

Annie LANNUZEL, PU-PH, Study Director, University Hospital of Guadeloupe


Verification Date

September 2019