Clinical trial NCT04653688: Markers of Disease Progression and Gait Within the Parkinsonian Population
Official title: A Prospective Study on Markers of Disease Progression and Gait Within the Parkinsonian Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Gait disorders
On-OFF detection
FOG detection
Quality of life
personalize medicine
telemedicine
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
name: France Parkinson Association
name: Vaincre Parkinson
name: FeetMe
First posted: 2020-12-04
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: 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.
timeFrame: at 48 weeks
Secondary outcomes:
measure: 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
timeFrame: at baseline at 12weeks, at 24 weeks and 48 weeks
measure: 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
timeFrame: at baseline at 12weeks, at 24 weeks and 48 weeks
measure: Changes of UMSARS I-II versus baseline in MSA subgroup
timeFrame: at baseline at 12weeks, at 24 weeks and 48 weeks
measure: Changes of MSA-QoL versus baseline in MSA subgroup
timeFrame: at baseline at 24 and 48 weeks
measure: Changes of OHQ versus baseline in MSA subgroup
timeFrame: at baseline at 24 and 48 weeks
measure: Changes of OHSA versus baseline in MSA subgroup
timeFrame: at baseline at 24 and 48 weeks
measure: Changes of BBS versus baseline in MSA subgroup
timeFrame: at baseline at 24 and 48 weeks
measure: Changes of Modified SE-ADL versus baseline in MSA subgroup
timeFrame: at baseline at 24 and 48 weeks
measure: Changes of PDSS-2 versus baseline in MSA subgroup
timeFrame: at baseline at 24 and 48 weeks
measure: Changes of COMPASS31 versus baseline in MSA subgroup
timeFrame: at baseline at 24 and 48 weeks
measure: Changes of MOCA versus baseline in MSA subgroup
timeFrame: at baseline at 24 and 48 weeks
measure: MRI changes at 24 and 48 weeks versus baseline.
timeFrame: at baseline at 24 and 48 weeks
measure: DAT-scan changes at 48 weeks versus baseline.
timeFrame: at baseline at 48 weeks
measure: PKG changes at 48 weeks versus baseline
timeFrame: at baseline and at 48 weeks
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Roger Salengro, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Caroline Moreau, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: