An observational study in Parkinson Disease, sponsored by Great Lakes NeuroTechnologies Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-12.
Sponsored by Great Lakes NeuroTechnologies Inc. · Observational
The purpose of this research study is to:
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 10 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Great Lakes NeuroTechnologies Inc. is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The population is people with Parkinson's Disease in the Northeast Ohio region who have expressed interest in participating in clinical trials
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.
Parkinson's Disease patients
Device: Kinesia 360 and Smartphone sensors
Data will be recorded from the Kinesia 360 system and smartphone sensors using the AWARE Framework.
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.
Time frame: Continuous during wear over four days
User environment audio activity
Using the AWARE Framework, the microphone in the smartphone will be used to measure ambient noise and detect conversation during wear. The output will be detection of conversation and ambient noise level for each recorded timepoint. The time involved in conversation and around active ambient noise will be compared to the symptom scores to measure user involvement in active environments as an impact on Parkinson's disease symptoms.
Time frame: Continuous during wear over four days
Patient physical activity
Using the AWARE Framework, accelerometers in the smartphone will be used to determine the activity of the user. The accelerometers will detect if the phone is being carried (using orientation of gravity) and predict most likely physical activity (using pre-existing activity recognition algorithms). The output will be predicted user activity for each timepoint recorded which will be correlated to Kinesia symptom scores.
Time frame: Continuous during wear over four days
Patient locations and travel
Using the AWARE Framework, Global Positioning System (GPS) tracking in the smartphone will be used to determine the locations and activity of the user. The GPS sensor will be used to track changes in location and determine when an user is at home (primary location), in a secondary location, or in active motion (car, bike, or walking). The outcome will be time spent in each location, percent of day at each location, and time and speed travelling between locations. These outcomes will be correlated to the Kinesia symptom scores and detected physical activity.
Time frame: Continuous during wear over four days
Plan to share: No
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Great Lakes NeuroTechnologies Inc.