Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers

Healthy Volunteers Clinical Trial

— Pre-QuantiPark  

Official title:

Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785978
• Other study ID #: Pre-QuantiPark
• Status: Completed
• Phase: N/A
• First received: May 11, 2016
• Last updated: October 9, 2017
• Start date: June 2016
• Est. completion date: July 2017

Study information

• Verified date: October 2017
• Source: Institut de Myologie, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Parkinson Disease

Intervention

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)
• 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

Locations

Country	Name	City	State
France	Service de Neurochirurgie, Hopital Henri Mondor	Creteil
France	Association Institut de Myologie	Paris
France	Département des Maladies du Système Nerveux, GH Pitie Salpatriere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Myologie, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Everyday life tasks measurement by ActiMyo®	PD patients and healthy volunteers Every day life tasks will be measured following ActiMyo® raw data analysis.	Baseline