Markers of Disease Progression and Gait Within the Parkinsonian Population - Clinical Trial for Parkinson Disease | NCT04653688

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

The FeetMe® Evaluation

the PKG® Watch,

MRI

DaTSCAN

About this trial

This is an interventional prevention trial for Parkinson Disease focused on measuring Gait disorders, On-OFF detection, FOG detection, Quality of life, personalize medicine, telemedicine

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

Hopital Roger Salengro, CHU LilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Parkinsonian syndromes patients

healthy subjects

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

Changes of UMSARS I-II versus baseline in MSA subgroup

UMSARS contains four parts, the UMSARS-1 and UMSARS-2 are reported in this outcome. UMSARS-1 scores symptoms of neurological and autonomic dysfunction (12 questions). UMSARS-2 is motor examination (14 questions). All questions range from 0 (normal) to 4(extreme dysfunction). Higher scores mean greater the impairment. Negative change from baseline values indicate improvement.

Changes of MSA-QoL versus baseline in MSA subgroup

MSA-QoL is a patient-rated health-related Quality of life scale for patients with multiple system atrophy (MSA). Visual Analog score is designed to determine overall life satisfaction in patient with MSA. Scale is given response option format (0 - extremely unsatisfied with life 100 - extremely satisfied with life), where higher scores indicate better satisfaction/quality of life.

Changes of OHQ versus baseline in MSA subgroup

OHQ : Oxford Happiness Questionnaire. The total score ranges from 8 to 54, with a higher number indicating better subjective wellness

Changes of OHSA versus baseline in MSA subgroup

Orthostatic Hypotension Symptom Assessment (OHSA) and Orthostatic Hypotension Daily Activities Scale (OHDAS) 10 items measured on a Likert-scale

Changes of BBS versus baseline in MSA subgroup

Berg Balance Scale (BBS) is a clinical 14-item scale designed to measure balance

Changes of Modified SE-ADL versus baseline in MSA subgroup

The Schwab and England Activities of Daily Living (SE-ADL) evaluates patients' perceptions of global functional capacity and dependence. Scoring is expressed in terms of percentage, in 10 steps from 100 to 0 (100% indicates completely independent, 0% indicates bedridden with impaired vegetative functions), so that the lower the score, the worse the functional status. The assessment is conducted by a trained clinician.

Changes of PDSS-2 versus baseline in MSA subgroup

The PDSS-2 is a 15-question instrument designed to simultaneously capture the multidimensional aspects of sleep-related problems and changes in sleep quality.

Changes of COMPASS31 versus baseline in MSA subgroup

Composite Autonomic Symptom Score (CONPASS 31) includes 31 questions and it will be used to assess autonomic symptoms that provides clinically relevant scores of autonomic symptom severity based. The higher the score the more autonomic symptoms present

Changes of MOCA versus baseline in MSA subgroup

MRI changes at 24 and 48 weeks versus baseline.

For MSA subgroup and all subgroups

DAT-scan changes at 48 weeks versus baseline.

For Early PD subgroup

PKG changes at 48 weeks versus baseline

in early PD and fluctuating subgroups.

Full Information

NCT ID

NCT04653688

First Posted

October 6, 2020

Last Updated

February 28, 2022

Sponsor

University Hospital, Lille

Collaborators

H. Lundbeck A/S, France Parkinson Association, Vaincre Parkinson, FeetMe

1. Study Identification

Unique Protocol Identification Number

NCT04653688

Brief Title

Markers of Disease Progression and Gait Within the Parkinsonian Population

Acronym

Gait'N'Park

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 22, 2020 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Lille

Collaborators

H. Lundbeck A/S, France Parkinson Association, Vaincre Parkinson, FeetMe

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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: 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: 30 Early PD patients, before 3 years of disease duration (MDS criteria, 2018) 30 PD patients with motor fluctuations (5 to 8 years of disease duration) (MDS criteria, 2018) 30 PD patients with FoG (10 years of disease duration) (MDS criteria, 2018) 30 patients with MSA (less than 5 years after the first symptom) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Parkinsonian syndromes patients

Arm Type

Experimental

Arm Title

healthy subjects

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

The FeetMe® Evaluation

Intervention Description

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

Intervention Name(s)

the PKG® Watch,

Intervention Description

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

Radiation

Intervention Name(s)

MRI

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

DaTSCAN

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Time Frame

at 48 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

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

Title

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

Time Frame

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

Title

Changes of UMSARS I-II versus baseline in MSA subgroup

Description

UMSARS contains four parts, the UMSARS-1 and UMSARS-2 are reported in this outcome. UMSARS-1 scores symptoms of neurological and autonomic dysfunction (12 questions). UMSARS-2 is motor examination (14 questions). All questions range from 0 (normal) to 4(extreme dysfunction). Higher scores mean greater the impairment. Negative change from baseline values indicate improvement.

Time Frame

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

Title

Changes of MSA-QoL versus baseline in MSA subgroup

Description

MSA-QoL is a patient-rated health-related Quality of life scale for patients with multiple system atrophy (MSA). Visual Analog score is designed to determine overall life satisfaction in patient with MSA. Scale is given response option format (0 - extremely unsatisfied with life 100 - extremely satisfied with life), where higher scores indicate better satisfaction/quality of life.

Time Frame