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

October 9, 2017 updated by: Institut de Myologie, France
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tremors measurement by ActiMyo®
Time Frame: Baseline

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®
Time Frame: Baseline

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®
Time Frame: Baseline

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Continuous home activity measurement by ActiMyo®
Time Frame: 2 weeks

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®
Time Frame: 2 weeks

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®
Time Frame: Baseline
PD patients and healthy volunteers Every day life tasks will be measured following ActiMyo® raw data analysis.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut de Myologie, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Teresa Gidaro, MD, PhD, Association Institut de Myologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pre-QuantiPark

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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