Markers of Disease Progression and Gait Within the Parkinsonian Population (Gait'N'Park)

University Hospital, Lille

Status: Completed

Conditions: Parkinson Disease

Treatments: Radiation: DaTSCAN; Radiation: MRI; Device: The FeetMe® Evaluation; Device: the PKG® Watch,

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04653688

2020-A01998-31 (Other Identifier)

2019_64

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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83 participants in 2 patient groups

Parkinsonian syndromes patients

Experimental group

Treatment:

Device: the PKG® Watch,

Device: The FeetMe® Evaluation

Radiation: MRI

Radiation: DaTSCAN

healthy subjects

Sham Comparator group

Treatment:

Device: The FeetMe® Evaluation

Radiation: MRI