Markers of Disease Progression and Gait Within the Parkinsonian Population

NCT ID: NCT04653688

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-22
• Study Completion Date: 2024-10-17

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Parkinsonian syndromes patients

Group Type: EXPERIMENTAL

The FeetMe® Evaluation

Intervention Type: DEVICE

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,

Intervention Type: DEVICE

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,

MRI

Intervention Type: RADIATION

• an anatomical 3D T1-weigthed gradient-echo sequence (1mm isotropic):
• anatomical registration
• automated segmentation
• volumetric
• texture analysis

DaTSCAN

Intervention Type: RADIATION

• quantify nigrostriatal dopaminergic depletion
• correlate its impact on the type and severity of gait disorders in Parkinson's disease.

healthy subjects

Group Type: SHAM_COMPARATOR

The FeetMe® Evaluation

Intervention Type: DEVICE

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.

MRI

Intervention Type: RADIATION

• an anatomical 3D T1-weigthed gradient-echo sequence (1mm isotropic):
• anatomical registration
• automated segmentation
• volumetric
• texture analysis

Interventions

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.

Intervention Type: 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,

Intervention Type: DEVICE

MRI

• an anatomical 3D T1-weigthed gradient-echo sequence (1mm isotropic):
• anatomical registration
• automated segmentation
• volumetric
• texture analysis

Intervention Type: RADIATION

DaTSCAN

• quantify nigrostriatal dopaminergic depletion
• correlate its impact on the type and severity of gait disorders in Parkinson's disease.

Intervention Type: RADIATION

Eligibility Criteria

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: collaborator

France Parkinson Association

OTHER

Sponsor Role: collaborator

Vaincre Parkinson

UNKNOWN

Sponsor Role: collaborator

FeetMe

INDUSTRY

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline Moreau, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hopital Roger Salengro, CHU Lille

Lille, , France

Countries

France

Other Identifiers

2020-A01998-31

Identifier Type: OTHER

Identifier Source: secondary_id

2019_64

Identifier Type: -

Identifier Source: org_study_id