NCT04096651

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

2.8 years

First QC Date

September 6, 2019

Last Update Submit

September 17, 2019

Conditions

Progressive Supranuclear Palsy

Keywords

progressive supranuclear palsy PSPatypical parkinsonismgait disordersneurophysiologyimaging

Outcome Measures

Primary Outcomes (1)

  • gait velocity

    gait recordings

    at inclusion

Secondary Outcomes (2)

  • brain anatomy

    at inclusion

  • oculomotor movements recordings

    at inclusion

Study Arms (3)

PSP Classic

OTHER

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

Other: gait recordingsOther: brain magnetic resonance imagingOther: oculomotor movement recordings

Caribbean PSP

OTHER

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

Other: gait recordingsOther: brain magnetic resonance imagingOther: oculomotor movement recordings

Healthy controls

OTHER

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

Other: gait recordingsOther: brain magnetic resonance imagingOther: oculomotor movement recordings

Interventions

gait recordingsOTHER

gait recordings

Caribbean PSPHealthy controlsPSP Classic
brain magnetic resonance imagingOTHER

brain magnetic resonance imaging

Caribbean PSPHealthy controlsPSP Classic
oculomotor movement recordingsOTHER

oculomotor movement recordings

Caribbean PSPHealthy controlsPSP Classic

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Supranuclear Palsy, ProgressiveMobility Limitation

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesNeurodegenerative DiseasesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Annie LANNUZEL, PU-PH

    University Hospital of Guadeloupe

    STUDY DIRECTOR

  • Régine EDRAGAS, PH

    University Hospital of Martinique

    PRINCIPAL INVESTIGATOR

  • Marie-Laure WELTER, PU-PH

    Groupe Hospitalier Pitie-Salpetriere

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 20, 2019

Study Start

September 28, 2015

Primary Completion

July 12, 2018

Study Completion

July 12, 2018

Last Updated

September 20, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share