Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers (Pre-QuantiPark)

Institut de Myologie, France

Status: Completed

Conditions: Healthy Volunteers; Parkinson Disease

Treatments: Device: ActiMyo recording; Drug: Levodopa acute challenge; Other: Standardized scales: MDS-UPDRS (Part II to IV) and RDRS; Other: Diary completion; Other: Controlled environment tests (series of tasks of everyday life)

Study type: Interventional

Funder types: Other

Identifiers

NCT02785978

Pre-QuantiPark

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Parkinson Disease Patients Group #1

Experimental group

Description:

PD patients with programmed levodopa challenge

Treatment:

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

Other: Controlled environment tests (series of tasks of everyday life)

Other: Diary completion

Device: ActiMyo recording

Drug: Levodopa acute challenge

Parkinson Disease Patients Group #2

Experimental group

Description:

PD patients without programmed levodopa challenge

Treatment:

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

Other: Controlled environment tests (series of tasks of everyday life)

Other: Diary completion

Device: ActiMyo recording

Healthy volunteers

Experimental group

Description:

Healthy volunteers

Treatment:

Other: Controlled environment tests (series of tasks of everyday life)

Other: Diary completion

Device: ActiMyo recording