A Prospective Study on Markers of Disease Progression and Gait Within the Parkinsonian Population

University Hospital, Lille1 site in 1 country83 target enrollmentDecember 22, 2020

ConditionsParkinson Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Parkinson Disease
Sponsor: University Hospital, Lille
Enrollment: 83
Locations: 1
Primary Endpoint: Changes of 95th percentile of home gait velocity (assessed during 10 days with FeetMe® Insoles) at 48 weeks versus baseline in Parkinsonian syndrome patient subgroups and in a control group.
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the project is to evaluate disease progression of patients with Parkinsonian syndrome of various severity through regular home-based gait parameters analysis.

We identified several steps in this project:

Acquisition of gait data in 120 patients with Parkinsonism at different stages in hospital and ecological condition (during 10 days at home), in a repetitive manner:
1. 30 Early PD patients, before 3 years of disease duration (MDS criteria, 2018)
2. 30 PD patients with motor fluctuations (5 to 8 years of disease duration) (MDS criteria, 2018)
3. 30 PD patients with FoG (10 years of disease duration) (MDS criteria, 2018)
4. 30 patients with MSA (less than 5 years after the first symptom)
Control groups will be composed by 30 healthy volunteers Correlation analysis with clinical measurements and biomarkers, namely blood biomarkers for neurodegeneration (4HN, NFLT …) and multimodal MRI repeated assessments (Iron overload, inflammation and degeneration) and genetic panel for common haplotypes involved in Parkinsonism.

Registry

clinicaltrials.gov

Start Date

December 22, 2020

End Date

October 17, 2024

Last Updated

4 months ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

University Hospital, Lille

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•PD Patients:
•Age: from 40 to 80 years
•Absence of intercurrent pathology that may interfere with the purpose of the study (rheumatologic or orthopedic condition, cardiac, severe pulmonary disease that may limit the perimeter of walking)
•Each group will be composed of:
•30 PD with a disease duration \< 3 years
•30 PD with a disease duration between 5 to 8 years
•30 PD with a disease duration \> 10 years MSA Patients
•Age \> 30 years old
•\< 5 years of disease duration
•deemed by the physicians to be able to walk at 1 year

Exclusion Criteria

•STN DBS for PD patients
•Intraduodeno-jejunal levodopa infusion (duodopa)
•Inability to walk without aid (walker or walking stick)

Outcomes

Primary Outcomes

Changes of 95th percentile of home gait velocity (assessed during 10 days with FeetMe® Insoles) at 48 weeks versus baseline in Parkinsonian syndrome patient subgroups and in a control group.

Time Frame: at 48 weeks

Secondary Outcomes

Changes of 95th percentile of home gait velocity (assessed during 10 days with FeetMe® Insoles) at 12 weeks (MSA subgroup only) and 24 weeks versus baseline in Parkinsonian syndrome patient subgroups(at baseline at 12weeks, at 24 weeks and 48 weeks)
Changes of 95th percentile of home gait cadence, stride length, stride, stance and swing durations (assessed during 10 days with FeetMe® Insoles) at 12 weeks (MSA subgroup only), 24 and 48 weeks versus baseline(at baseline at 12weeks, at 24 weeks and 48 weeks)
Changes of UMSARS I-II versus baseline in MSA subgroup(at baseline at 12weeks, at 24 weeks and 48 weeks)
Changes of MSA-QoL versus baseline in MSA subgroup(at baseline at 24 and 48 weeks)
Changes of OHQ versus baseline in MSA subgroup(at baseline at 24 and 48 weeks)
Changes of OHSA versus baseline in MSA subgroup(at baseline at 24 and 48 weeks)
Changes of BBS versus baseline in MSA subgroup(at baseline at 24 and 48 weeks)
Changes of Modified SE-ADL versus baseline in MSA subgroup(at baseline at 24 and 48 weeks)
Changes of PDSS-2 versus baseline in MSA subgroup(at baseline at 24 and 48 weeks)
Changes of COMPASS31 versus baseline in MSA subgroup(at baseline at 24 and 48 weeks)
Changes of MOCA versus baseline in MSA subgroup(at baseline at 24 and 48 weeks)
MRI changes at 24 and 48 weeks versus baseline.(at baseline at 24 and 48 weeks)
DAT-scan changes at 48 weeks versus baseline.(at baseline at 48 weeks)
PKG changes at 48 weeks versus baseline(at baseline and at 48 weeks)