Markers of Disease Progression and Gait Within the Parkinsonian Population

NCT04653688 | Completed DMC

• 2 other identifiers: 2019_642020-A01998-31
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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. 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:
2. 2.30 Early PD patients, before 3 years of disease duration (MDS criteria, 2018)
3. 3.30 PD patients with motor fluctuations (5 to 8 years of disease duration) (MDS criteria, 2018)
4. 4.30 PD patients with FoG (10 years of disease duration) (MDS criteria, 2018)
5. 5.30 patients with MSA (less than 5 years after the first symptom)
6. 6.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

Keywords

Gait disorders; On-OFF detection; FOG detection; Quality of life; personalize medicine; telemedicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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

• 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

• Changes of UMSARS I-II versus baseline in MSA subgroup

  at baseline at 12weeks, at 24 weeks and 48 weeks

• Changes of MSA-QoL versus baseline in MSA subgroup

  at baseline at 24 and 48 weeks

• Changes of OHQ versus baseline in MSA subgroup

  at baseline at 24 and 48 weeks

Study Arms (2)

Parkinsonian syndromes patients

EXPERIMENTAL

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

healthy subjects

SHAM COMPARATOR

Device: The FeetMe® Evaluation; Radiation: MRI

Interventions

The FeetMe® Evaluation 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.

Parkinsonian syndromes patients; healthy subjects

the PKG® Watch, 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,

Parkinsonian syndromes patients

MRI RADIATION

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

Parkinsonian syndromes patients; healthy subjects

DaTSCAN RADIATION

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

Parkinsonian syndromes patients

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• PD with a disease duration \< 3 years
• PD with a disease duration between 5 to 8 years
• 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)

You may not qualify if:

• STN DBS for PD patients
• Intraduodeno-jejunal levodopa infusion (duodopa)
• Inability to walk without aid (walker or walking stick)

Sponsors & Collaborators

• University Hospital, Lille: lead
• H. Lundbeck A/S: collaborator
• France Parkinson Association: collaborator
• Vaincre Parkinson: collaborator
• FeetMe: collaborator

Study Sites (1)

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation

Interventions

ioflupane

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Caroline Moreau, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: December 4, 2020
• Study Start: December 22, 2020
• Primary Completion: October 17, 2024
• Study Completion: October 17, 2024
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

FR (1)