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

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ClinicalTrials.gov Identifier: NCT02785978
Recruitment Status : Completed
First Posted : May 30, 2016
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Institut de Myologie, France

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Healthy Volunteers 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers
Actual Study Start Date : June 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Experimental: Healthy volunteers
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




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.



Secondary Outcome Measures :
  1. 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. 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.


  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785978


Locations
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France
Service de Neurochirurgie, Hopital Henri Mondor
Creteil, France, 94010
Association Institut de Myologie
Paris, France, 75651
Département des Maladies du Système Nerveux, GH Pitie Salpatriere
Paris, France, 75651
Sponsors and Collaborators
Institut de Myologie, France
Investigators
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Principal Investigator: Teresa Gidaro, MD, PhD Association Institut de Myologie

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Responsible Party: Institut de Myologie, France
ClinicalTrials.gov Identifier: NCT02785978     History of Changes
Other Study ID Numbers: Pre-QuantiPark
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs