Markers of Disease Progression and Gait Within the Parkinsonian Population

Parkinson Disease Clinical Trial

— Gait'N'Park  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04653688
• Other study ID #: 2019_64
• Secondary ID: 2020-A01998-31
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2020
• Est. completion date: January 2024

Study information

• Verified date: February 2022
• Source: University Hospital, Lille
• Contact: Caroline Moreau, MD,PhD
• Phone: 0320445962
• Email: caroline.moreau[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Disease Progression
• Parkinson Disease

Intervention

Device:
• The FeetMe® Evaluation
The FeetMe® Evaluation device is a medical device (class Im CE 0459) for ambulatory gait analysis, consisting of a pair of connected insoles and an Android mobile application.
• the PKG® Watch,
The PKG® provides continuous, objective, ambulatory assessment of the treatable and disabling symptoms of Parkinson's disease including tremor, bradykinesia and dyskinesia. The PKG® system consists of a wrist-worn movement recording device known as the PKG® Watch,

Radiation:
• MRI
an anatomical 3D T1-weigthed gradient-echo sequence (1mm isotropic): anatomical registration automated segmentation volumetric texture analysis
• DaTSCAN
quantify nigrostriatal dopaminergic depletion correlate its impact on the type and severity of gait disorders in Parkinson's disease.

Locations

Country	Name	City	State
France	Hopital Roger Salengro, CHU Lille	Lille

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Lille	FeetMe, France Parkinson Association, H. Lundbeck A/S, Vaincre Parkinson

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Changes of UMSARS I-II versus baseline in MSA subgroup	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.	at baseline at 12weeks, at 24 weeks and 48 weeks
Secondary	Changes of MSA-QoL versus baseline in MSA subgroup	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.	at baseline at 24 and 48 weeks
Secondary	Changes of OHQ versus baseline in MSA subgroup	OHQ : Oxford Happiness Questionnaire. The total score ranges from 8 to 54, with a higher number indicating better subjective wellness	at baseline at 24 and 48 weeks
Secondary	Changes of OHSA versus baseline in MSA subgroup	Orthostatic Hypotension Symptom Assessment (OHSA) and Orthostatic Hypotension Daily Activities Scale (OHDAS) 10 items measured on a Likert-scale	at baseline at 24 and 48 weeks
Secondary	Changes of BBS versus baseline in MSA subgroup	Berg Balance Scale (BBS) is a clinical 14-item scale designed to measure balance	at baseline at 24 and 48 weeks
Secondary	Changes of Modified SE-ADL versus baseline in MSA subgroup	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.	at baseline at 24 and 48 weeks
Secondary	Changes of PDSS-2 versus baseline in MSA subgroup	The PDSS-2 is a 15-question instrument designed to simultaneously capture the multidimensional aspects of sleep-related problems and changes in sleep quality.	at baseline at 24 and 48 weeks
Secondary	Changes of COMPASS31 versus baseline in MSA subgroup	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	at baseline at 24 and 48 weeks
Secondary	Changes of MOCA versus baseline in MSA subgroup		at baseline at 24 and 48 weeks
Secondary	MRI changes at 24 and 48 weeks versus baseline.	For MSA subgroup and all subgroups	at baseline at 24 and 48 weeks
Secondary	DAT-scan changes at 48 weeks versus baseline.	For Early PD subgroup	at baseline at 48 weeks
Secondary	PKG changes at 48 weeks versus baseline	in early PD and fluctuating subgroups.	at baseline and at 48 weeks