Objective Quality of Life Detection Validation
DiSCERN Phase I - Objective Quality of Life Detection Validation
2 other identifiers
observational
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 20, 2019
CompletedFirst Submitted
Initial submission to the registry
September 26, 2019
CompletedFirst Posted
Study publicly available on registry
October 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedAugust 12, 2020
March 1, 2020
9 months
September 26, 2019
August 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Kinesia Symptom Scores during Daily Wear
Kinesia 360 scoring of Parkinson's Disease motor symptoms (tremor, slowness, dyskinesia, gait): The Kinesia 360 system translates recorded motion into 0-4 scores that correlate to rating scales used by clinicians (lower scores are signifiers of better outcomes and higher scores signify worse outcomes). A separate 0-4 score is generated for tremor, slowness, and dyskinesia, and gait is tracked for step count and percent of day walking.
Continuous during wear over four days
Secondary Outcomes (3)
User environment audio activity
Continuous during wear over four days
Patient physical activity
Continuous during wear over four days
Patient locations and travel
Continuous during wear over four days
Study Arms (1)
Parkinson's Disease
Parkinson's Disease patients
Interventions
Data will be recorded from the Kinesia 360 system and smartphone sensors using the AWARE Framework.
Eligibility Criteria
The population is people with Parkinson's Disease in the Northeast Ohio region who have expressed interest in participating in clinical trials
You may qualify if:
- Able to provide informed consent
- Diagnosed with PD
- Hoehn and Yahr scale I-III
- Able to travel to Great Lakes NeuroTechnologies
- Ambulatory and capable of using the Kinesia 360 system
- Able to understand and follow instructions regarding using the device
You may not qualify if:
- Any subject that does not meet the subject selection criteria will be excluded from this study. Children will be excluded from this study due to the fact that they are unlikely to have PD. Subjects that are not capable of functioning independently or are so symptomatic as to compromise their safety will also be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Great Lakes NeuroTechnologies
Cleveland, Ohio, 44131, United States
Related Publications (1)
Heldman DA, Giuffrida JP, Cubo E. Wearable Sensors for Advanced Therapy Referral in Parkinson's Disease. J Parkinsons Dis. 2016 Jul 2;6(3):631-8. doi: 10.3233/JPD-160830.
PMID: 27392872BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dustin Heldman, PhD
Director of Research
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2019
First Posted
October 10, 2019
Study Start
September 20, 2019
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
August 12, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share