Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers

Study Overview
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Brief Summary
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Pre-QuantiPark is a pilot study to evaluate the reliability and responsiveness of ActiMyo measured activity in PD patients. The purpose of the study is to provide validation of the ActiMyo, an innovative home-recording device enabling use in clinical trials and as an innovative tool for PD patient care.

Official Title
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Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers

Conditions
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Parkinson Disease, Healthy Volunteers

Intervention / Treatment
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* Drug: Levodopa acute challenge
* Other: Controlled environment tests (series of tasks of everyday life)
* Other: Standardized scales: MDS-UPDRS (Part II to IV) and RDRS
* Device: ActiMyo recording
* Other: Diary completion


Participation Criteria
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Eligibility Criteria
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Patients: Inclusion criteria Clinical diagnosis of idiopathic PD (UKPDSBB criteria) On stable parkinsonian medication regimen including levodopa for at least 4 weeks Male of female aged ≥18 years old Experiencing motor fluctuations and dyskinesia MoCA (Montreal Cognitive Assessment) ≥ 26 Willing to adhere and comply to the protocol requirements as evi-dence by written informed consent Capable and willing to accurately using Actimyo Capable and willing to complete diaries Unlimited broadband internet access at home Agrees to be filmed Affiliated to or a beneficiary of a social security scheme PD patients subgroup #1 only: levodopa acute test scheduled as part of usual care Exclusion Criteria Undergone surgery for the treatment of PD Apomorphine or Levodopa Pump in place Deep brain stimulation or transcranial magnetic stimulation Drug-induced parkinsonism Vascular parkinsonism Parkinson plus syndromes (such as multiple system atrophy, pro-gressive supranuclear palsy, and corticobasal degeneration) Other neurodegenerative disorders Any other significant medical or psychiatric illness that could inter-fere with study evaluation For women: pregnancy or current breastfeeding Under legal protection Healthy subjects: Inclusion criteria Male of female matched by age with PD patients ; aged ≥ 18 Willing to adhere and comply to the protocol requirements as evi-dence by written informed consent Capable and willing to accurately using Actimyo Capable and willing to complete diaries MoCA (Montreal Cognitive Assessment) ≥ 26 Unlimited broadband internet access at home Agrees to be filmed Affiliated to or a beneficiary of a social security scheme Exclusion Criteria Any significant medical or psychiatric illness that could interfere with study evaluation For women: pregnancy or current breastfeeding Under legal protection Close or near relation of investigators, Institute of Myology employ-ees, or AFM-Telethon members.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parkinson Disease Patients Group #1<br>PD patients with programmed levodopa challenge | Drug: Levodopa acute challenge<br>* Inclusion visit (simultaneous video + ActiMyo recording): Levodopa acute challenge and 2 hours of recording and medical monitoring<br>Other: Controlled environment tests (series of tasks of everyday life)<br>* Inclusion visit (simultaneous video + ActiMyo recording): Controlled environment tests (series of tasks of everyday life)<br>Other: Standardized scales: MDS-UPDRS (Part II to IV) and RDRS<br>* Inclusion visit (simultaneous video + ActiMyo recording): Standardized scales: MDS-UPDRS (Part II to IV) and RDRS<br>Device: ActiMyo recording<br>* Continuous activity recording with ActiMyo during the 2 weeks of study participation<br>Other: Diary completion<br>* Daily patient logbook completion during the 2 weeks of study participation<br>|
| Experimental: Parkinson Disease Patients Group #2<br>PD patients without programmed levodopa challenge | Other: Controlled environment tests (series of tasks of everyday life)<br>* Inclusion visit (simultaneous video + ActiMyo recording): Controlled environment tests (series of tasks of everyday life)<br>Other: Standardized scales: MDS-UPDRS (Part II to IV) and RDRS<br>* Inclusion visit (simultaneous video + ActiMyo recording): Standardized scales: MDS-UPDRS (Part II to IV) and RDRS<br>Device: ActiMyo recording<br>* Continuous activity recording with ActiMyo during the 2 weeks of study participation<br>Other: Diary completion<br>* Daily patient logbook completion during the 2 weeks of study participation<br>|
| Experimental: Healthy volunteers<br>Healthy volunteers | Other: Controlled environment tests (series of tasks of everyday life)<br>* Inclusion visit (simultaneous video + ActiMyo recording): Controlled environment tests (series of tasks of everyday life)<br>Device: ActiMyo recording<br>* Continuous activity recording with ActiMyo during the 2 weeks of study participation<br>Other: Diary completion<br>* Daily patient logbook completion during the 2 weeks of study participation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tremors measurement by ActiMyo® | PD patients only; 1 to 3 hours of simultaneous video + ActiMyo® sensors recording and physician evaluation (tasks of every day life, MDS-UPDRS, RDRS and physician worksheet); Small steps will be detected and quantified following ActiMyo® raw data analysis and results will be compared to physician evaluation. | Baseline | 
| Small steps measurement by ActiMyo® | PD patients only; 1 to 3 hours of simultaneous video + ActiMyo® sensors recording and physician evaluation (tasks of every day life, MDS-UPDRS, RDRS and physician worksheet); Small steps will be detected and quantified following ActiMyo® raw data analysis and results will be compared to physician evaluation. | Baseline | 
| Dyskinesia measurement by ActiMyo® | PD patients only; 1 to 3 hours of simultaneous video + ActiMyo® sensors recording and physician evaluation (tasks of every day life, MDS-UPDRS, RDRS and physician worksheet); Dyskinesia will be detected and quantified following ActiMyo® raw data analysis and results will be compared to physician evaluation. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous home activity measurement by ActiMyo® | Subjects (PD patients and healthy volunteers) will wear ActiMyo® sensors everyday during 2 weeks and complete a hand-written paper diary to record their activity. Activity variables will be deduced from ActiMyo® raw data analysis. | 2 weeks | 
| Off, On without dyskinesia, on with dyskinesia states measurement by ActiMyo® | PD patients will wear ActiMyo® sensors everyday during 2 weeks and complete a hand-written paper diary to record their state (Off, On without dyskinesia, on with dyskinesia). Off, On without dyskinesia, on with dyskinesia states will be measured following ActiMyo® raw data analysis and compared to hand-written paper diary indicating states. | 2 weeks | 
| Everyday life tasks measurement by ActiMyo® | PD patients and healthy volunteers Every day life tasks will be measured following ActiMyo® raw data analysis. | Baseline |