Trials / Completed
CompletedNCT04121793
Objective Quality of Life Detection Validation
DiSCERN Phase I - Objective Quality of Life Detection Validation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 10 (actual)
- Sponsor
- Great Lakes NeuroTechnologies Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study is to: * Collect data to use in the development of a standardized tool for identifying patients with Parkinson's disease (PD) who would benefit from advanced therapies (AT) such as deep brain stimulation (DBS) and drug pumps. * Determine the level to which specific activities reflect with quality of life in individuals with PD. * Obtain feedback from individuals with Parkinson's disease and clinicians on the usability of the system.
Detailed description
The investigators aim to develop a standardized tool for identifying patients with Parkinson's disease (PD) who would benefit from advanced therapies (AT) and identify when AT recipients are in need of a therapy adjustment. This system will integrate ambulatory PD monitoring with context aware activity detection as the daily activities a patient performs are often the best predictors of quality of life (QoL). In this study the Kinesia 360 system will collect motion data to measure tremor, bradykinesia (slow movement), and dyskinesia (involuntary movements) from individuals with PD to track their symptoms throughout the day. A smartphone will collect information on subject location and activity using the GPS, accelerometers, and microphone within the phone to find correlations between activity and patient wellness. This data will be used to improve detection over time and predict whether patients are candidates for advanced therapies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Kinesia 360 and Smartphone sensors | Data will be recorded from the Kinesia 360 system and smartphone sensors using the AWARE Framework. |
Timeline
- Start date
- 2019-09-20
- Primary completion
- 2020-06-30
- Completion
- 2020-06-30
- First posted
- 2019-10-10
- Last updated
- 2020-08-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04121793. Inclusion in this directory is not an endorsement.