Objective Quality of Life Detection Validation

NCT ID: NCT04121793

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-20
• Study Completion Date: 2020-06-30

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.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Parkinson's Disease

Parkinson's Disease patients

Kinesia 360 and Smartphone sensors

Intervention Type: DEVICE

Data will be recorded from the Kinesia 360 system and smartphone sensors using the AWARE Framework.

Interventions

Kinesia 360 and Smartphone sensors

Data will be recorded from the Kinesia 360 system and smartphone sensors using the AWARE Framework.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Great Lakes NeuroTechnologies Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dustin Heldman, PhD

Role: PRINCIPAL_INVESTIGATOR

Director of Research

Locations

Great Lakes NeuroTechnologies

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 27392872 (View on PubMed)

Other Identifiers

1R44MD013767-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DiSCERN1

Identifier Type: -

Identifier Source: org_study_id