Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers
NCT ID: NCT02785978
Last Updated: 2017-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2016-06-30
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Parkinson Disease Patients Group #1
PD patients with programmed levodopa challenge
Levodopa acute challenge
Inclusion visit (simultaneous video + ActiMyo recording):
Levodopa acute challenge and 2 hours of recording and medical monitoring
Controlled environment tests (series of tasks of everyday life)
Inclusion visit (simultaneous video + ActiMyo recording):
Controlled environment tests (series of tasks of everyday life)
Standardized 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
ActiMyo recording
Continuous activity recording with ActiMyo during the 2 weeks of study participation
Diary completion
Daily patient logbook completion during the 2 weeks of study participation
Parkinson Disease Patients Group #2
PD patients without programmed levodopa challenge
Controlled environment tests (series of tasks of everyday life)
Inclusion visit (simultaneous video + ActiMyo recording):
Controlled environment tests (series of tasks of everyday life)
Standardized 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
ActiMyo recording
Continuous activity recording with ActiMyo during the 2 weeks of study participation
Diary completion
Daily patient logbook completion during the 2 weeks of study participation
Healthy volunteers
Healthy volunteers
Controlled environment tests (series of tasks of everyday life)
Inclusion visit (simultaneous video + ActiMyo recording):
Controlled environment tests (series of tasks of everyday life)
ActiMyo recording
Continuous activity recording with ActiMyo during the 2 weeks of study participation
Diary completion
Daily patient logbook completion during the 2 weeks of study participation
Interventions
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Levodopa acute challenge
Inclusion visit (simultaneous video + ActiMyo recording):
Levodopa acute challenge and 2 hours of recording and medical monitoring
Controlled environment tests (series of tasks of everyday life)
Inclusion visit (simultaneous video + ActiMyo recording):
Controlled environment tests (series of tasks of everyday life)
Standardized 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
ActiMyo recording
Continuous activity recording with ActiMyo during the 2 weeks of study participation
Diary completion
Daily patient logbook completion during the 2 weeks of study participation
Eligibility Criteria
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Inclusion 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
* 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
* 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:
* 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.
18 Years
ALL
Yes
Sponsors
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Institut de Myologie, France
OTHER
Responsible Party
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Principal Investigators
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Teresa Gidaro, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Association Institut de Myologie
Locations
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Service de Neurochirurgie, Hopital Henri Mondor
Créteil, , France
Association Institut de Myologie
Paris, , France
Département des Maladies du Système Nerveux, GH Pitie Salpatriere
Paris, , France
Countries
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Other Identifiers
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Pre-QuantiPark
Identifier Type: -
Identifier Source: org_study_id