Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers (Pre-QuantiPark)

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Healthy Volunteers
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Creteil, France, 94010
    • Service de Neurochirurgie, Hopital Henri Mondor
  • Paris, France, 75651
    • Association Institut de Myologie
  • Paris, France, 75651
    • Département des Maladies du Système Nerveux, GH Pitie Salpatriere

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy volunteers	Other: Controlled environment tests (series of tasks of everyday life); Inclusion visit (simultaneous video + ActiMyo recording): Controlled environment tests (series of tasks of everyday life); Device: ActiMyo recording; Continuous activity recording with ActiMyo during the 2 weeks of study participation; Other: Diary completion; Daily patient logbook completion during the 2 weeks of study participation
Experimental: Parkinson Disease Patients Group #1; PD patients with programmed levodopa challenge	Drug: Levodopa acute challenge; Inclusion visit (simultaneous video + ActiMyo recording): Levodopa acute challenge and 2 hours of recording and medical monitoring; Other: Controlled environment tests (series of tasks of everyday life); Inclusion visit (simultaneous video + ActiMyo recording): Controlled environment tests (series of tasks of everyday life); Other: 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; Device: ActiMyo recording; Continuous activity recording with ActiMyo during the 2 weeks of study participation; Other: Diary completion; Daily patient logbook completion during the 2 weeks of study participation
Experimental: Parkinson Disease Patients Group #2; PD patients without programmed levodopa challenge	Other: Controlled environment tests (series of tasks of everyday life); Inclusion visit (simultaneous video + ActiMyo recording): Controlled environment tests (series of tasks of everyday life); Other: 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; Device: ActiMyo recording; Continuous activity recording with ActiMyo during the 2 weeks of study participation; Other: Diary completion; Daily patient logbook completion during the 2 weeks of study participation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut de Myologie, France
• Investigators: Principal Investigator: Teresa Gidaro, MD, PhD, Association Institut de Myologie

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: May 11, 2016
• First Submitted That Met QC Criteria: May 27, 2016
• First Posted (Estimate): May 30, 2016

Study Record Updates

• Last Update Posted (Actual): October 10, 2017
• Last Update Submitted That Met QC Criteria: October 9, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Levodopa
• Other Study ID Numbers: Pre-QuantiPark