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Completed

NCT Number: NCT02657655

Kinesia 360 Parkinson's Monitoring Study

Kinesia 360 is an ambulatory symptom monitoring device for Parkinson's Disease (PD). The aim of this study is to investigate the impact, validation, and usability of the Kinesia 360 system.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies Tremor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University, Baltimore, Maryland, United States

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About this study

This is a five-month study of 45 subjects (approximately 15 subjects per site), consisting of adult volunteers that have been clinically diagnosed with Parkinson's disease. Subjects will have a confirmed history of motor fluctuation with a variety of Parkinson's disease symptom severities. All subjects will user the Kinesia 360 system and complete motor diaries several times per month during the study period. Symptom reports will be provided to the treating clinical team. Motor function, quality of life, engagement, and satisfaction with care will be tracked throughout the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Idiopathic Parkinson's Disease,
  • History of motor fluctuations (2 hrs/day of Off time and/or 1 hr/day of troublesome dyskinesia)
  • Fluent in English

Exclusion criteria

  • Inability to carry out study activities
  • Subjects with cognitive deficits that would prevent following instructions and serious medical conditions that would compromise a subject's safety
  • Subjects who have dementia, exhibited by Montreal Cognitive Assessment (MoCa) score of 22 or less.
  • Subjects who have had Deep Brain Stimulation (DBS) surgery less than 6 months prior to study enrollment, or who are deemed by the study investigator to be highly likely to undergo DBS surgery during the 6 month study period.

Treatment and study plan

Kinesia 360

Device

Kinesia 360 includes a mobile app and wireless motion sensors worn on the patient's wrist and ankle to quantify tremor, dyskinesias, and mobility throughout the day as he or she goes about normal activities. The app includes electronic diaries enable patients to rate their symptoms and log when medications are taken. Data is transferred to a cloud server where motor symptom reports are generated for clinician review.

Primary outcomes

  1. % of assigned days with confirmed use

    Time frame: 5 months

Secondary outcomes

  1. Diary measured Off time

    Time frame: 5 months

  2. Diary measured On time with dyskinesia

    Time frame: 5 months

  3. Off time as measured by Kinesia 360

    Time frame: 5 months

  4. On time with dyskinesia as measured by Kinesia 360

    Time frame: 5 months

  5. PDQ-39 responses

    Time frame: 5 months

  6. Patient Assessment for Chronic Conditions (PACIC) responses

    Time frame: 5 months

  7. Patient Activation Measure (PAM)-13 responses

    Time frame: 5 months

  8. Number of clinic visits

    Time frame: 5 months

  9. Number of patient/investigator communications

    Time frame: 5 months

  10. Unified Parkinson's disease rating scale (UPDRS)

    Time frame: 5 months

  11. Duration of time with patient

    Time frame: 5 months

  12. Number and type of medication changes

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

Great Lakes NeuroTechnologies Inc.

Industry

Collaborators

  • Johns Hopkins University
  • National Institute on Aging (NIA)
  • Prisma Health-Upstate
  • The Cleveland Clinic
  • University of Rochester
  • University of South Carolina School of Medicine, Greenville

Registry information

Official study title

Kinesia 360 Multi-Center Parkinson's Monitoring Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 18, 2016
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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