Parkinson's DiseaseNCT02657655
Kinesia 360 Parkinson's Monitoring Study
A study testing Kinesia 360 in people with Parkinson's Disease, run by Great Lakes NeuroTechnologies Inc. at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Kinesia 360
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21218
Cleveland Clinic
Cleveland, Ohio, 44195
Greenville Health System
Greenville, South Carolina, 29615
University of Rochester
Rochester, New York, 14642
About this study
Official title: Kinesia 360 Multi-Center 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.
Read the detailed description
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.
- Conditions
- Parkinson's Disease
- Being tested
- Kinesia 360
- Keywords
- Parkinson's Disease, Dyskinesia, Tremor, Symptom Management, Technology, Wearable Sensors, Continuous Monitoring, Mobility
- Medical subject headings
- Parkinson Disease, Dyskinesias, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesia 360Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Kinesia 360 Users | Experimental | Parkinson's patients will be monitored continuously using wearable Kinesia 360 sensors. Receives: Device: Kinesia 360 |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of assigned days with confirmed use
Measured: 5 months
Secondary outcomes (12)
Diary measured Off time
Measured: 5 months
Diary measured On time with dyskinesia
Measured: 5 months
Off time as measured by Kinesia 360
Measured: 5 months
On time with dyskinesia as measured by Kinesia 360
Measured: 5 months
PDQ-39 responses
Measured: 5 months
Patient Assessment for Chronic Conditions (PACIC) responses
Measured: 5 months
Patient Activation Measure (PAM)-13 responses
Measured: 5 months
Number of clinic visits
Measured: 5 months
Number of patient/investigator communications
Measured: 5 months
Unified Parkinson's disease rating scale (UPDRS)
Measured: 5 months
Duration of time with patient
Measured: 5 months
Number and type of medication changes
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of South Carolina School of Medicine, Greenville, University of Rochester, Johns Hopkins University, Prisma Health-Upstate, National Institute on Aging (NIA), The Cleveland Clinic
- Responsible party
- Sponsor
- Investigators
- Dustin Heldman, PhD, Principal investigator, Great Lakes NeuroTechnologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657655
- Sponsor's protocol ID
- GLNT-K360-1
- Other IDs
- 5R44AG044293-04, 5R44AG033947-05, Pro000048239
- Status last verified
- Feb 2018
- First submitted
- 14 Jan 2016
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesia 360 Multi-Center Parkinson's Monitoring Study
- ClinicalTrials.gov ID
- NCT02657655
- Acronym / sponsor ID
- GLNT-K360-1
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Dyskinesia, Tremor, Symptom Management, Technology, Wearable Sensors, Continuous Monitoring, Mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of South Carolina School of Medicine, Greenville, University of Rochester, Johns Hopkins University, Prisma Health-Upstate, National Institute on Aging (NIA), The Cleveland Clinic
- Study start
- Jan 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 18 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kinesia 360 Users | Experimental | Device: Kinesia 360Parkinson's patients will be monitored continuously using wearable Kinesia 360 sensors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesia 360Kinesia 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. | Device | Kinesia 360 Users |
Primary outcome
% of assigned days with confirmed use
Time frame: 5 months
12 secondary outcomes
Diary measured Off time
Time frame: 5 months
Diary measured On time with dyskinesia
Time frame: 5 months
Off time as measured by Kinesia 360
Time frame: 5 months
On time with dyskinesia as measured by Kinesia 360
Time frame: 5 months
PDQ-39 responses
Time frame: 5 months
Patient Assessment for Chronic Conditions (PACIC) responses
Time frame: 5 months
Patient Activation Measure (PAM)-13 responses
Time frame: 5 months
Number of clinic visits
Time frame: 5 months
Number of patient/investigator communications
Time frame: 5 months
Unified Parkinson's disease rating scale (UPDRS)
Time frame: 5 months
Duration of time with patient
Time frame: 5 months
Number and type of medication changes
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dustin Heldman, PhD principal investigator
Great Lakes NeuroTechnologies Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesia 360 in people with Parkinson's Disease, run by Great Lakes NeuroTechnologies Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of assigned days with confirmed use (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.