Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-03 @ 11:27 PM
Study NCT ID:
NCT04121793
Status:
COMPLETED
Last Update Posted:
2020-08-12
First Post:
2019-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Objective Quality of Life Detection Validation
Sponsor:
Great Lakes NeuroTechnologies Inc.
Organization:
Study Overview
Official Title:
DiSCERN Phase I - Objective Quality of Life Detection Validation
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R44MD013767-01 | NIH | None | https://reporter.nih.gov/quic… | View |