Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers
Pre-QuantiPark
1 other identifier
interventional
30
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable parkinson-disease
Started Jun 2016
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2016
CompletedFirst Posted
Study publicly available on registry
May 30, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedOctober 10, 2017
October 1, 2017
1 year
May 11, 2016
October 9, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
Continuous home activity measurement by ActiMyo®
2 weeks
Off, On without dyskinesia, on with dyskinesia states measurement by ActiMyo®
2 weeks
Everyday life tasks measurement by ActiMyo®
Baseline
Study Arms (3)
Parkinson Disease Patients Group #1
EXPERIMENTALPD patients with programmed levodopa challenge
Parkinson Disease Patients Group #2
EXPERIMENTALPD patients without programmed levodopa challenge
Healthy volunteers
EXPERIMENTALHealthy volunteers
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Service de Neurochirurgie, Hopital Henri Mondor
Créteil, 94010, France
Association Institut de Myologie
Paris, 75651, France
Département des Maladies du Système Nerveux, GH Pitie Salpatriere
Paris, 75651, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Teresa Gidaro, MD, PhD
Association Institut de Myologie
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2016
First Posted
May 30, 2016
Study Start
June 1, 2016
Primary Completion
June 1, 2017
Study Completion
July 1, 2017
Last Updated
October 10, 2017
Record last verified: 2017-10