Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management

PHASE4CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 16, 2017

Primary Completion Date

January 2, 2018

Study Completion Date

January 2, 2018

Conditions
Parkinson´s Disease
Interventions
DEVICE

Kinesia-ONE™

Kinesia-ONE™ wearable sensor uses a subject-worn finger sensor and iPad mini application (APP) to objectively measure specific motor tasks related to Parkinson's disease symptoms such as tremor, bradykinesia (slowed movements), and dyskinesia (involuntary movements) in the Investigator's office. Subjects should wear the Kinesia-ONE™ device on the most affected side.

DEVICE

Kinesia-360™

Kinesia-360™ wearable sensor includes a wrist and ankle device, along with a cell phone, which is also APP-based, and is designed for continuous day time monitoring of Parkinson's disease symptoms. Subjects will wear Kinesia-360™ while they go about their daily lives, and symptom severity is continually captured to enable objective assessment of Parkinson's disease symptoms. Subjects should wear the Kinesia-360™ device bands on the most affected side.

DRUG

Rotigotine

All subjects will start Neupro treatment at a dose of either rotigotine 2 mg/24 h or 4 mg/24 h (according to the disease stage of the subject) which will then be adjusted based on symptom assessment either via standard care alone or via a combination of standard care and evaluation of the recordings made available by the Kinesia wearable technologies.

Trial Locations (8)

11725

Pd0049 106, Commack

29615

Pd0049 107, Greenville

33486

Pd0049 102, Boca Raton

60190

Pd0049 108, Winfield

66160

Pd0049 103, Kansas City

74136

Pd0049 104, Tulsa

77030

Pd0049 109, Houston

92708

Pd0049 105, Fountain Valley

All Listed Sponsors
lead

UCB Biopharma S.P.R.L.

INDUSTRY

NCT03103919 - Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management | Biotech Hunter | Biotech Hunter