Official Title
Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers
Phase
N/ALead Sponsor
Institut de Myologie, FranceStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Parkinson Disease Healthy VolunteersIntervention/Treatment
levodopa ...Study Participants
30Pre-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.
Inclusion visit (simultaneous video + ActiMyo recording): Levodopa acute challenge and 2 hours of recording and medical monitoring
Inclusion visit (simultaneous video + ActiMyo recording): Controlled environment tests (series of tasks of everyday life)
Inclusion visit (simultaneous video + ActiMyo recording): Standardized scales: MDS-UPDRS (Part II to IV) and RDRS
Continuous activity recording with ActiMyo during the 2 weeks of study participation
Daily patient logbook completion during the 2 weeks of study participation
PD patients with programmed levodopa challenge
PD patients without programmed levodopa challenge
Healthy volunteers
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.
