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

Institut de Myologie, France30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Parkinson Disease Healthy Volunteers

Interventions

Levodopa acute challengeDRUG

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 RDRSOTHER

Inclusion visit (simultaneous video + ActiMyo recording): Standardized scales: MDS-UPDRS (Part II to IV) and RDRS

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Service de Neurochirurgie, Hopital Henri Mondor

Créteil, France

Association Institut de Myologie

Paris, France

Département des Maladies du Système Nerveux, GH Pitie Salpatriere

Paris, France

Outcomes

Primary Outcomes

Tremors measurement by ActiMyo®

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.

Time frame: Baseline

Small steps measurement by ActiMyo®

Time frame: Baseline

Dyskinesia measurement by ActiMyo®

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.

Time frame: Baseline

Secondary Outcomes

Continuous home activity measurement by ActiMyo®

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.

Time frame: 2 weeks

Off, On without dyskinesia, on with dyskinesia states measurement by ActiMyo®

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.

Data from ClinicalTrials.gov

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