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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02785978
• Date of registration: 11/05/2016
• Prospective Registration: Yes
• Primary sponsor: Institut de Myologie, France
• Public title: Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers Pre-QuantiPark
• Scientific title: Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers
• Date of first enrolment: June 2016
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02785978
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Teresa Gidaro, MD, PhD
• Affiliation: Association Institut de Myologie

Key inclusion & 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Parkinson Disease

Intervention(s)

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

Device: ActiMyo recording

Other: Diary completion

Drug: Levodopa acute challenge

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

Primary Outcome(s)

Small steps measurement by ActiMyo® [Time Frame: Baseline]

Tremors measurement by ActiMyo® [Time Frame: Baseline]

Dyskinesia measurement by ActiMyo® [Time Frame: Baseline]

Secondary Outcome(s)

Continuous home activity measurement by ActiMyo® [Time Frame: 2 weeks]

Off, On without dyskinesia, on with dyskinesia states measurement by ActiMyo® [Time Frame: 2 weeks]

Everyday life tasks measurement by ActiMyo® [Time Frame: Baseline]

Secondary ID(s)

Pre-QuantiPark

Source(s) of Monetary Support

Please refer to primary and secondary sponsors