Parkinson's DiseaseNCT01356056
Tele-diagnostics for Remote Parkinson's Monitoring
An observational study of Parkinson's Disease, run by Great Lakes NeuroTechnologies Inc. at 1 site in United States.
Trial summary
The purpose of this research study is to design, implement, and clinically assess a portable, user worn system for monitoring Parkinson's disease (PD) motor symptoms. The current standard in evaluating symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a subjective, qualitative ranking system. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Kinesia HomeView
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2011
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Parkinson's disease
Who may be able to join
- Clinical diagnosis of Parkinson's disease
Who cannot join
- Inability to follow the required clinical instruction
- Subjects with cognitive impairments that would prohibit them from properly using the Kinesia HomeView system
- Subjects without the cognitive ability to respond to researchers and let them know when any parameters of the study may become uncomfortable
- Subjects found on examination by our clinicians to have any physical limitations which would be counter productive to participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to design, implement, and clinically assess a portable, user worn system for monitoring Parkinson's disease (PD) motor symptoms. The current standard in evaluating symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a subjective, qualitative ranking system. The main goal of this research is to develop a quantitative system, Kinesia HomeView, to assess tremor as well as different features of bradykinesia in a home based system which can capture those symptom changes over the course of a day and aid in evaluating treatment protocol efficacy.
- Conditions
- Parkinson's Disease
- Being tested
- Kinesia HomeView
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesia HomeViewDevice
Quantifies motor symptom severity in the home
| Study group | Role | What they receive |
|---|---|---|
| Kinesia HomeView Monitoring | Uses Kinesia HomeView at home once per week Receives: Device: Kinesia HomeView | |
| Control | Assessed in the clinic every 4 weeks using traditional methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS
Measured: Every 4 weeks
PDQ-39
Measured: Every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2011
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Cincinnati
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356056
- Sponsor's protocol ID
- 10-09-29-03EE
- Other IDs
- 7R43NS065554-03, 5R43MD004049-02
- Status last verified
- Mar 2013
- First submitted
- 17 May 2011
- Last updated
- 12 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-diagnostics for Remote Parkinson's Monitoring
- ClinicalTrials.gov ID
- NCT01356056
- Acronym / sponsor ID
- 10-09-29-03EE
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Cincinnati
- Study start
- May 2011
- Primary completion
- Dec 2011 (actual)
- First posted
- 19 May 2011 (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.
The purpose of this research study is to design, implement, and clinically assess a portable, user worn system for monitoring Parkinson's disease (PD) motor symptoms. The current standard in evaluating symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a subjective, qualitative ranking system. The main goal of this research is to develop a quantitative system, Kinesia HomeView, to assess tremor as well as different features of bradykinesia in a home based system which can capture those symptom changes over the course of a day and aid in evaluating treatment protocol efficacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesia HomeView Monitoring | – | Device: Kinesia HomeViewUses Kinesia HomeView at home once per week |
| Control | – | –Assessed in the clinic every 4 weeks using traditional methods |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Parkinson's disease
Key inclusion criteria (1 listed)
- Clinical diagnosis of Parkinson's disease
Key exclusion criteria (4 listed)
- Inability to follow the required clinical instruction
- Subjects with cognitive impairments that would prohibit them from properly using the Kinesia HomeView system
- Subjects without the cognitive ability to respond to researchers and let them know when any parameters of the study may become uncomfortable
- Subjects found on examination by our clinicians to have any physical limitations which would be counter productive to participation in this study.
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 HomeViewQuantifies motor symptom severity in the home | Device | Kinesia HomeView Monitoring |
Primary outcome
UPDRS
Time frame: Every 4 weeks
PDQ-39
Time frame: Every 4 weeks
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 12 Mar 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Great Lakes NeuroTechnologies Inc. at 1 site 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 1 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 12 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
UPDRS (time frame: Every 4 weeks). The study lists 2 primary outcomes in all. 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 12 Mar 2013.