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

Primary Purpose

Parkinson Disease, Healthy Volunteers

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Levodopa acute challenge
Controlled environment tests (series of tasks of everyday life)
Standardized scales: MDS-UPDRS (Part II to IV) and RDRS
ActiMyo recording
Diary completion
Sponsored by
Institut de Myologie, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Parkinson Disease Patients Group #1

Parkinson Disease Patients Group #2

Healthy volunteers

Arm Description

PD patients with programmed levodopa challenge

PD patients without programmed levodopa challenge

Healthy volunteers

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
Everyday life tasks measurement by ActiMyo®
PD patients and healthy volunteers Every day life tasks will be measured following ActiMyo® raw data analysis.

Full Information

First Posted
May 11, 2016
Last Updated
October 9, 2017
Sponsor
Institut de Myologie, France
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1. Study Identification

Unique Protocol Identification Number
NCT02785978
Brief Title
Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers
Acronym
Pre-QuantiPark
Official Title
Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Myologie, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Healthy Volunteers

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parkinson Disease Patients Group #1
Arm Type
Experimental
Arm Description
PD patients with programmed levodopa challenge
Arm Title
Parkinson Disease Patients Group #2
Arm Type
Experimental
Arm Description
PD patients without programmed levodopa challenge
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
Healthy volunteers
Intervention Type
Drug
Intervention Name(s)
Levodopa acute challenge
Intervention Description
Inclusion visit (simultaneous video + ActiMyo recording): Levodopa acute challenge and 2 hours of recording and medical monitoring
Intervention Type
Other
Intervention Name(s)
Controlled environment tests (series of tasks of everyday life)
Intervention Description
Inclusion visit (simultaneous video + ActiMyo recording): Controlled environment tests (series of tasks of everyday life)
Intervention Type
Other
Intervention Name(s)
Standardized scales: MDS-UPDRS (Part II to IV) and RDRS
Intervention Description
Inclusion visit (simultaneous video + ActiMyo recording): Standardized scales: MDS-UPDRS (Part II to IV) and RDRS
Intervention Type
Device
Intervention Name(s)
ActiMyo recording
Intervention Description
Continuous activity recording with ActiMyo during the 2 weeks of study participation
Intervention Type
Other
Intervention Name(s)
Diary completion
Intervention Description
Daily patient logbook completion during the 2 weeks of study participation
Primary Outcome Measure Information:
Title
Tremors measurement by ActiMyo®
Description
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.
Time Frame
Baseline
Title
Small steps measurement by ActiMyo®
Description
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.
Time Frame
Baseline
Title
Dyskinesia measurement by ActiMyo®
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Continuous home activity measurement by ActiMyo®
Description
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.
Time Frame
2 weeks
Title
Off, On without dyskinesia, on with dyskinesia states measurement by ActiMyo®
Description
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.
Time Frame
2 weeks
Title
Everyday life tasks measurement by ActiMyo®
Description
PD patients and healthy volunteers Every day life tasks will be measured following ActiMyo® raw data analysis.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Gidaro, MD, PhD
Organizational Affiliation
Association Institut de Myologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Neurochirurgie, Hopital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Association Institut de Myologie
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Département des Maladies du Système Nerveux, GH Pitie Salpatriere
City
Paris
ZIP/Postal Code
75651
Country
France

12. IPD Sharing Statement

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

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