Markers of Disease Progression and Gait Within the Parkinsonian Population

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Device: The FeetMe® Evaluation; Device: the PKG® Watch,; Radiation: MRI; Radiation: DaTSCAN

• Registration Number: NCT04653688
• Lead Sponsor: University Hospital, Lille

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:

1. 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)

2. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-11-26
• Study First Posted: 2020-12-04
• Study Start: 2020-12-22
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-15
• Primary Completion: 2024-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Healthy subjects

• Similar age and sex distribution

For all

• 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)
• Absence of cognitive disorders (MoCA> 24/30 according to the MDS criteria)
• Stable treatment for at least 2 weeks before inclusion
• Ability to walk at least 100 meters
• Have an affiliation to the social security or equivalent
• Have signed an informed consent

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Parkinsonian syndromes patients	MRI	-
healthy subjects	The FeetMe® Evaluation	-
Parkinsonian syndromes patients	The FeetMe® Evaluation	-
Parkinsonian syndromes patients	DaTSCAN	-
Parkinsonian syndromes patients	the PKG® Watch,	-
healthy subjects	MRI	-

Primary Outcome Measures

Name	Time	Method
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.	at 48 weeks

Secondary Outcome Measures

Name	Time	Method
Changes of MOCA versus baseline in MSA subgroup	at baseline at 24 and 48 weeks
PKG changes at 48 weeks versus baseline	at baseline and at 48 weeks	in early PD and fluctuating subgroups.
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	UMSARS contains four parts, the UMSARS-1 and UMSARS-2 are reported in this outcome. UMSARS-1 scores symptoms of neurological and autonomic dysfunction (12 questions). UMSARS-2 is motor examination (14 questions). All questions range from 0 (normal) to 4(extreme dysfunction). Higher scores mean greater the impairment. Negative change from baseline values indicate improvement.
Changes of MSA-QoL versus baseline in MSA subgroup	at baseline at 24 and 48 weeks	MSA-QoL is a patient-rated health-related Quality of life scale for patients with multiple system atrophy (MSA). Visual Analog score is designed to determine overall life satisfaction in patient with MSA. Scale is given response option format (0 - extremely unsatisfied with life 100 - extremely satisfied with life), where higher scores indicate better satisfaction/quality of life.
Changes of OHQ versus baseline in MSA subgroup	at baseline at 24 and 48 weeks	OHQ : Oxford Happiness Questionnaire. The total score ranges from 8 to 54, with a higher number indicating better subjective wellness
Changes of OHSA versus baseline in MSA subgroup	at baseline at 24 and 48 weeks	Orthostatic Hypotension Symptom Assessment (OHSA) and Orthostatic Hypotension Daily Activities Scale (OHDAS) 10 items measured on a Likert-scale
Changes of BBS versus baseline in MSA subgroup	at baseline at 24 and 48 weeks	Berg Balance Scale (BBS) is a clinical 14-item scale designed to measure balance
Changes of Modified SE-ADL versus baseline in MSA subgroup	at baseline at 24 and 48 weeks	The Schwab and England Activities of Daily Living (SE-ADL) evaluates patients' perceptions of global functional capacity and dependence. Scoring is expressed in terms of percentage, in 10 steps from 100 to 0 (100% indicates completely independent, 0% indicates bedridden with impaired vegetative functions), so that the lower the score, the worse the functional status. The assessment is conducted by a trained clinician.
Changes of PDSS-2 versus baseline in MSA subgroup	at baseline at 24 and 48 weeks	The PDSS-2 is a 15-question instrument designed to simultaneously capture the multidimensional aspects of sleep-related problems and changes in sleep quality.
Changes of COMPASS31 versus baseline in MSA subgroup	at baseline at 24 and 48 weeks	Composite Autonomic Symptom Score (CONPASS 31) includes 31 questions and it will be used to assess autonomic symptoms that provides clinically relevant scores of autonomic symptom severity based. The higher the score the more autonomic symptoms present
MRI changes at 24 and 48 weeks versus baseline.	at baseline at 24 and 48 weeks	For MSA subgroup and all subgroups
DAT-scan changes at 48 weeks versus baseline.	at baseline at 48 weeks	For Early PD subgroup

Trial Locations

Locations (1)

Hopital Roger Salengro, CHU Lille; 🇫🇷 Lille, France