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
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
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
NCT ID
NCT04096651
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
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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