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

NCT03103919 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-02-19

Study results available
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Summary

Evaluate the benefits of Kinesia-360™ wearable technology in addition to standard clinical practice on improving Parkinson´s disease motor symptoms, Neupro dosing regimen and adherence to Neupro compared with only standard clinical practice.

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.

Sponsors & Collaborators

  • UCB Biopharma S.P.R.L.

    lead INDUSTRY

Principal Investigators

  • UCB Cares · +1 844 599 2273 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-16
Primary Completion
2018-01-02
Completion
2018-01-02
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03103919 on ClinicalTrials.gov