Objective Quality of Life Detection Validation

Great Lakes NeuroTechnologies

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: Kinesia 360 and Smartphone sensors

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT04121793

1R44MD013767-01 (U.S. NIH Grant/Contract)

DiSCERN1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

10 participants in 1 patient group

Parkinson's Disease

Description:

Parkinson's Disease patients

Treatment:

Device: Kinesia 360 and Smartphone sensors