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

Sponsored by Institut de Myologie, France

About this trial

Last updated 8 years ago

Study ID

Pre-QuantiPark

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Trial Timing

Ended 8 years ago

What is this trial 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.

What are the Participation Requirements?

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.