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

Status: Completed
Location: See all (3) locations...
Intervention Type: Device, Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: Accepts Healthy Volunteers
View:

• 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

• 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

Locations
Other Locations
France
Service de Neurochirurgie, Hopital Henri Mondor
Creteil
Association Institut de Myologie
Paris
Département des Maladies du Système Nerveux, GH Pitie Salpatriere
Paris
Time Frame
Start Date: June 2016
Completion Date: July 2017
Participants
Target number of participants: 30
Treatments
Experimental: Parkinson Disease Patients Group #1
PD patients with programmed levodopa challenge
Experimental: Parkinson Disease Patients Group #2
PD patients without programmed levodopa challenge
Experimental: Healthy volunteers
Healthy volunteers
Sponsors
Leads: Institut de Myologie, France

This content was sourced from clinicaltrials.gov

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