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Completed

NCT Number: NCT02785978

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Healthy Volunteers Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Neurochirurgie, Hopital Henri Mondor, Créteil, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levodopa acute challenge

Drug

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 RDRS

Other

Inclusion visit (simultaneous video + ActiMyo recording):

Standardized scales: MDS-UPDRS (Part II to IV) and RDRS

ActiMyo recording

Device

Continuous activity recording with ActiMyo during the 2 weeks of study participation

Diary completion

Other

Daily patient logbook completion during the 2 weeks of study participation

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Institut de Myologie, France

Other

Registry information

Acronym: Pre-QuantiPark

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 30, 2016
Registry last updated
Oct 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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