Markers of Disease Progression and Gait Within the Parkinsonian Population

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

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.

Sponsors & Collaborators

• H. Lundbeck A/S

  collaborator INDUSTRY

• France Parkinson Association

  collaborator OTHER

• Vaincre Parkinson

  collaborator UNKNOWN

• FeetMe

  collaborator INDUSTRY

• University Hospital, Lille

  lead OTHER

Principal Investigators

• Caroline Moreau, MD,PhD · University Hospital, Lille

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

30 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-12-22

Primary Completion

2024-10-17

Completion

2024-10-17

Countries

• France

Study Locations