Healthy Volunteers, Parkinson Disease
Conditions
Brief summary
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.
Interventions
DRUGLevodopa acute challenge
Inclusion visit (simultaneous video + ActiMyo recording): Levodopa acute challenge and 2 hours of recording and medical monitoring
OTHERControlled environment tests (series of tasks of everyday life)
Inclusion visit (simultaneous video + ActiMyo recording): Controlled environment tests (series of tasks of everyday life)
OTHERStandardized scales: MDS-UPDRS (Part II to IV) and RDRS
Inclusion visit (simultaneous video + ActiMyo recording): Standardized scales: MDS-UPDRS (Part II to IV) and RDRS
DEVICEActiMyo recording
Continuous activity recording with ActiMyo during the 2 weeks of study participation
OTHERDiary completion
Daily patient logbook completion during the 2 weeks of study participation
Sponsors
Institut de Myologie, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tremors measurement by ActiMyo® | Baseline | 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. |
| Small steps measurement by ActiMyo® | Baseline | 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. |
| Dyskinesia measurement by ActiMyo® | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continuous home activity measurement by ActiMyo® | 2 weeks | 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. |
| Off, On without dyskinesia, on with dyskinesia states measurement by ActiMyo® | 2 weeks | 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. |
| Everyday life tasks measurement by ActiMyo® | Baseline | PD patients and healthy volunteers Every day life tasks will be measured following ActiMyo® raw data analysis. |
Countries
France
Outcome results
None listed