Parkinson DiseasePre-QuantiParkNCT02785978
Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers
A study testing Levodopa acute challenge, Standardized scales: MDS-UPDRS (Part II to IV) and RDRS and ActiMyo recording in people with Parkinson Disease and Healthy Volunteers, run by Institut de Myologie, France at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Healthy Volunteers
- What is being tested?
- Levodopa acute challenge, Standardized scales: MDS-UPDRS (Part II to IV) and RDRS and ActiMyo recording
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- Jun 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service de Neurochirurgie, Hopital Henri Mondor
Créteil, 94010
Association Institut de Myologie
Paris, 75651
Département des Maladies du Système Nerveux, GH Pitie Salpatriere
Paris, 75651
About this study
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.
- Conditions
- Parkinson Disease, Healthy Volunteers
- Being tested
- 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
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levodopa acute challengeDrug
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)Other
Inclusion visit (simultaneous video + ActiMyo recording):
Controlled environment tests (series of tasks of everyday life)
Standardized scales: MDS-UPDRS (Part II to IV) and RDRSOther
Inclusion visit (simultaneous video + ActiMyo recording):
Standardized scales: MDS-UPDRS (Part II to IV) and RDRS
ActiMyo recordingDevice
Continuous activity recording with ActiMyo during the 2 weeks of study participation
Diary completionOther
Daily patient logbook completion during the 2 weeks of study participation
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Disease Patients Group #1 | Experimental | PD patients with programmed levodopa challenge Receives: 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 |
| Parkinson Disease Patients Group #2 | Experimental | PD patients without programmed levodopa challenge Receives: 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 |
| Healthy volunteers | Experimental | Healthy volunteers Receives: Other: Controlled environment tests (series of tasks of everyday life); Device: ActiMyo recording; Other: Diary completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Myologie, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresa Gidaro, MD, PhD, Principal investigator, Association Institut de Myologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785978
- Sponsor's protocol ID
- Pre-QuantiPark
- Acronym
- Pre-QuantiPark
- Status last verified
- Oct 2017
- First submitted
- 11 May 2016
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02785978
- Acronym / sponsor ID
- Pre-QuantiPark / Pre-QuantiPark
- Conditions
- Parkinson Disease, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institut de Myologie, FranceUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 30 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinson Disease Patients Group #1 | Experimental | 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 completionPD patients with programmed levodopa challenge |
| Parkinson Disease Patients Group #2 | Experimental | 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 completionPD patients without programmed levodopa challenge |
| Healthy volunteers | Experimental | Other: Controlled environment tests (series of tasks of everyday life), Device: ActiMyo recording, Other: Diary completionHealthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levodopa acute challengeInclusion visit (simultaneous video + ActiMyo recording): Levodopa acute challenge and 2 hours of recording and medical monitoring | Drug | Parkinson Disease Patients Group #1 |
| 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 | Healthy volunteers, Parkinson Disease Patients Group #1, Parkinson Disease Patients Group #2 |
| Standardized scales: MDS-UPDRS (Part II to IV) and RDRSInclusion visit (simultaneous video + ActiMyo recording): Standardized scales: MDS-UPDRS (Part II to IV) and RDRS | Other | Parkinson Disease Patients Group #1, Parkinson Disease Patients Group #2 |
| ActiMyo recordingContinuous activity recording with ActiMyo during the 2 weeks of study participation | Device | Healthy volunteers, Parkinson Disease Patients Group #1, Parkinson Disease Patients Group #2 |
| Diary completionDaily patient logbook completion during the 2 weeks of study participation | Other | Healthy volunteers, Parkinson Disease Patients Group #1, Parkinson Disease Patients Group #2 |
Primary outcome
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.
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.
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.
3 secondary outcomes
Continuous home activity measurement by ActiMyo®
Time frame: 2 weeks
Off, On without dyskinesia, on with dyskinesia states measurement by ActiMyo®
Time frame: 2 weeks
Everyday life tasks measurement by ActiMyo®
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Gidaro, MD, PhD principal investigator
Association Institut de Myologie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levodopa acute challenge, Standardized scales: MDS-UPDRS (Part II to IV) and RDRS and ActiMyo recording in people with Parkinson Disease and Healthy Volunteers, run by Institut de Myologie, France at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tremors measurement by ActiMyo® (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2017; AzTrials last refreshed its copy on 6 Nov 2026.