Clinical trial NCT04121793: Objective Quality of Life Detection Validation
Official title: DiSCERN Phase I - Objective Quality of Life Detection Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Great Lakes NeuroTechnologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2019-10-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is people with Parkinson's Disease in the Northeast Ohio region who have expressed interest in participating in clinical trials

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Able to provide informed consent
2. Diagnosed with PD
3. Hoehn and Yahr scale I-III
4. Able to travel to Great Lakes NeuroTechnologies
5. Ambulatory and capable of using the Kinesia 360 system
6. Able to understand and follow instructions regarding using the device

Exclusion Criteria:

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.

Primary outcomes:
measure: Kinesia Symptom Scores during Daily Wear
timeFrame: Continuous during wear over four days
Secondary outcomes:
measure: User environment audio activity
timeFrame: Continuous during wear over four days
measure: Patient physical activity
timeFrame: Continuous during wear over four days
measure: Patient locations and travel
timeFrame: Continuous during wear over four days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Great Lakes NeuroTechnologies
state: Ohio
Study officials:
affiliation: Director of Research
name: Dustin Heldman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.