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Objective Quality of Life Detection Validation

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ClinicalTrials.gov Identifier: NCT04121793
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Great Lakes NeuroTechnologies Inc.

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.

Condition or disease Intervention/treatment
Parkinson Disease Device: Kinesia 360 and Smartphone sensors

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: DiSCERN Phase I - Objective Quality of Life Detection Validation
Actual Study Start Date : September 20, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Parkinson's Disease
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.




Primary Outcome Measures :
  1. Kinesia Symptom Scores during Daily Wear [ Time Frame: Continuous during wear over four days ]
    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.


Secondary Outcome Measures :
  1. User environment audio activity [ Time Frame: Continuous during wear over four days ]
    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.

  2. Patient physical activity [ Time Frame: Continuous during wear over four days ]
    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.

  3. Patient locations and travel [ Time Frame: Continuous during wear over four days ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121793


Contacts
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Contact: Aaron J Hadley, PhD (216) 446-2452 ahadley@glneurotech.com
Contact: Dustin Heldman, PhD 216-361-5410 dheldman@glneurotech.com

Locations
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United States, Ohio
Great Lakes NeuroTechnologies Recruiting
Cleveland, Ohio, United States, 44131
Contact: Aaron J Hadley, PhD    216-446-2452    ahadley@glneurotech.com   
Contact: Dustin Heldman, PhD    216-361-5410    dheldman@glneurotech.com   
Sponsors and Collaborators
Great Lakes NeuroTechnologies Inc.
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Dustin Heldman, PhD Director of Research

Publications:
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Responsible Party: Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier: NCT04121793     History of Changes
Other Study ID Numbers: DiSCERN1
1R44MD013767-01 ( U.S. NIH Grant/Contract )
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases