Clinical trial NCT02785978: Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers
Official title: Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Healthy Volunteers
Lead sponsor: Institut de Myologie, France
Sponsor class: OTHER
First posted: 2016-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Tremors measurement by ActiMyo®
timeFrame: Baseline
measure: Small steps measurement by ActiMyo®
timeFrame: Baseline
measure: Dyskinesia measurement by ActiMyo®
timeFrame: Baseline
Secondary outcomes:
measure: Continuous home activity measurement by ActiMyo®
timeFrame: 2 weeks
measure: Off, On without dyskinesia, on with dyskinesia states measurement by ActiMyo®
timeFrame: 2 weeks
measure: Everyday life tasks measurement by ActiMyo®
timeFrame: Baseline
Other outcomes:
Locations:
city: Creteil
country: France
facility: Service de Neurochirurgie, Hopital Henri Mondor
city: Paris
country: France
facility: Association Institut de Myologie
city: Paris
country: France
facility: Département des Maladies du Système Nerveux, GH Pitie Salpatriere
Study officials:
affiliation: Association Institut de Myologie
name: Teresa Gidaro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: