NCT04653688

Markers of Disease Progression and Gait Within the Parkinsonian Population

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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.
DEVICE	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
RADIATION	DaTSCAN	* quantify nigrostriatal dopaminergic depletion * correlate its impact on the type and severity of gait disorders in Parkinson's disease.

Timeline

• Start date: 2020-12-22
• Primary completion: 2024-10-17
• Completion: 2024-10-17
• First posted: 2020-12-04
• Last updated: 2025-12-04

Locations

1 site across 1 country: France