Parkinson's DiseaseNCT01920425
Kinesia HomeView - Home Diary Comparison
A study testing Kinesia HomeView and Hand-written diary in people with Parkinson's Disease, run by Great Lakes NeuroTechnologies Inc. at 1 site in United States.
Trial summary
The objective is to compare the sensitivity and test-retest reliability of Kinesia HomeView to electronic and hand-written diaries for tracking medication state in the home. Demonstrating comparable or superior results will further support use of the Kinesia HomeView system as an outcome measure in clinical drug… 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 HomeView and Hand-written diary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Sep 2015
- 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
- Clinical diagnosis of Parkinson's disease
- On a stable antiparkinsonian medication regimen that includes levodopa for at least 4 weeks
- Experiencing dyskinesia more than 25% of the waking day (score ≥ 2 on Unified Parkinson's Disease Rating Scale item 32)
- With dyskinesias at least moderately disabling (score ≥ 2 on Unified Parkinson's Disease Rating Scale item 33)
- Capable of accurately completing diaries
- Capable of accurately using Kinesia HomeView
Who cannot join
- Significant medical or psychiatric illness
- Subjects not capable of following the required clinical instructions
- Serious medical conditions that would compromise safety
Trial locations and contacts
1 site in 1 country.
United States1 site
Great Lakes NeuroTechnologies Inc
Valley View, Ohio, 44125
About this study
The objective is to compare the sensitivity and test-retest reliability of Kinesia HomeView to electronic and hand-written diaries for tracking medication state in the home. Demonstrating comparable or superior results will further support use of the Kinesia HomeView system as an outcome measure in clinical drug trials.
- Conditions
- Parkinson's Disease
- Being tested
- Kinesia HomeView, Hand-written diary
- Keywords
- Parkinson's disease, dyskinesia, fluctuations, tremor, bradykinesia, levodopa
- Medical subject headings
- Parkinson Disease, Dyskinesias, Tremor, Hypokinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesia HomeViewDevice
Motion sensor based telemedicine system for assessment of movement disorder motor symptoms in the home. Includes automated motor assessment using motion sensor and electronic dyskinesia diary.
Hand-written diaryOther
Hand-written paper diary indicating state (Off, On without dyskinesias, on with non-troublesome dyskinesias, on with troublesome dyskinesias) at 30 minute intervals.
| Study group | Role | What they receive |
|---|---|---|
| Hand-written diary first | Other | Participants in this group will use the hand-written diary for the first two week and switch to Kinesia HomeView and the electronic diary for the second two weeks. Receives: Device: Kinesia HomeView; Other: Hand-written diary |
| Kinesia HomeView first | Other | Participants in this group will use Kinesia HomeView and the electronic diary for the first two week and switch to the hand-written diary for the second two weeks. Receives: Device: Kinesia HomeView; Other: Hand-written diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest reliability
Test-retest reliability will be compared between Kinesia HomeView measures, hand-written diary entries, and electronic diary entries.
Measured: 4 weeks
Secondary outcomes (1)
Kinesia HomeView usability questionnaire
Questionnaires on the usability of Kinesia HomeView will be completed following the 4-week data collection period.
Measured: After 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2015
- Study completionSep 2015
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dustin A Heldman, PhD, Principal investigator, Great Lakes NeuroTechnologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920425
- Sponsor's protocol ID
- 1311DH
- Other IDs
- 1311DH
- Status last verified
- Jan 2016
- First submitted
- 7 Aug 2013
- Last updated
- 12 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesia HomeView - Home Diary Comparison
- ClinicalTrials.gov ID
- NCT01920425
- Acronym / sponsor ID
- 1311DH
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, dyskinesia, fluctuations, tremor, bradykinesia, levodopa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 12 Aug 2013 (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 objective is to compare the sensitivity and test-retest reliability of Kinesia HomeView to electronic and hand-written diaries for tracking medication state in the home. Demonstrating comparable or superior results will further support use of the Kinesia HomeView system as an outcome measure in clinical drug trials.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand-written diary first | Other | Device: Kinesia HomeView, Other: Hand-written diaryParticipants in this group will use the hand-written diary for the first two week and switch to Kinesia HomeView and the electronic diary for the second two weeks. |
| Kinesia HomeView first | Other | Device: Kinesia HomeView, Other: Hand-written diaryParticipants in this group will use Kinesia HomeView and the electronic diary for the first two week and switch to the hand-written diary for the second two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of Parkinson's disease
- On a stable antiparkinsonian medication regimen that includes levodopa for at least 4 weeks
- Experiencing dyskinesia more than 25% of the waking day (score ≥ 2 on Unified Parkinson's Disease Rating Scale item 32)
- With dyskinesias at least moderately disabling (score ≥ 2 on Unified Parkinson's Disease Rating Scale item 33)
- Capable of accurately completing diaries
Key exclusion criteria (3 listed)
- Significant medical or psychiatric illness
- Subjects not capable of following the required clinical instructions
- Serious medical conditions that would compromise safety
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 HomeViewMotion sensor based telemedicine system for assessment of movement disorder motor symptoms in the home. Includes automated motor assessment using motion sensor and electronic dyskinesia diary. | Device | Hand-written diary first, Kinesia HomeView first |
| Hand-written diaryHand-written paper diary indicating state (Off, On without dyskinesias, on with non-troublesome dyskinesias, on with troublesome dyskinesias) at 30 minute intervals. | Other | Hand-written diary first, Kinesia HomeView first |
Primary outcome
Test-retest reliability
Time frame: 4 weeks
Test-retest reliability will be compared between Kinesia HomeView measures, hand-written diary entries, and electronic diary entries.
1 secondary outcome
Kinesia HomeView usability questionnaire
Time frame: After 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 Jan 2016.
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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 A Heldman, PhD principal investigator
Great Lakes NeuroTechnologies Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesia HomeView and Hand-written diary in people with 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 6 inclusion and 3 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 Jan 2016. 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?
Test-retest reliability (time frame: 4 weeks). 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 Jan 2016.