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

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institut de Myologie, France
• Treatments: Levodopa

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.