Parkinson's DiseaseKinesia-DNCT02125825
Ambulatory Parkinson's Disease Dyskinesia Monitor for Drug Therapy Titration
An observational study of Parkinson's Disease, run by Great Lakes NeuroTechnologies Inc. at 2 sites in United States.
Trial summary
The objective is to assess a compact, portable, wireless movement disorder system with continuous monitoring capabilities to detect and quantify the severity of levodopa-induced dyskinesia in Parkinson's disease. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Parkinson's Disease
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Dec 2014
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with Parkinson's disease and a history of levodopa-induced dyskinesia
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease
- Clinical history of levodopa-induced dyskinesia
- 21 Years of age or older
- Stage 2 - 4 OFF-medication on the Hoehn and Yahr scale
Who cannot join
- Dementia (determined by a neuropsychological assessment)
- Severe tremor unaffected by levodopa
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Medical Center
Baltimore, Maryland, 21287
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Kinesia-D Phase II In-Clinic Continuous Assessment Study
The objective is to assess a compact, portable, wireless movement disorder system with continuous monitoring capabilities to detect and quantify the severity of levodopa-induced dyskinesia in Parkinson's disease.
- Conditions
- Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease on levodopa | Individuals with Parkinson's disease who are taking levodopa to treat motor symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between motion sensor features and clinician-rated dyskinesia severity
Motor function (movement speed and magnitude measured with a motion sensor) will be collected for a period of 2 hours after taking normally prescribed dose of levodopa.
Measured: All data will be collected within a single session not to exceed 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionDec 2014
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
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), University of Rochester, Johns Hopkins University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125825
- Sponsor's protocol ID
- KinesiaDPhaseIIYear1
- Other IDs
- 9R44AG044293
- Acronym
- Kinesia-D
- Status last verified
- Jan 2016
- First submitted
- 25 Apr 2014
- 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-D Phase II In-Clinic Continuous Assessment Study
- ClinicalTrials.gov ID
- NCT02125825
- Acronym / sponsor ID
- Kinesia-D / KinesiaDPhaseIIYear1
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), University of Rochester, Johns Hopkins University
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Apr 2014 (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 assess a compact, portable, wireless movement disorder system with continuous monitoring capabilities to detect and quantify the severity of levodopa-induced dyskinesia in Parkinson's disease.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease on levodopa | – | –Individuals with Parkinson's disease who are taking levodopa to treat motor symptoms |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with Parkinson's disease and a history of levodopa-induced dyskinesia
Key inclusion criteria (4 listed)
- Diagnosis of idiopathic Parkinson's disease
- Clinical history of levodopa-induced dyskinesia
- 21 Years of age or older
- Stage 2 - 4 OFF-medication on the Hoehn and Yahr scale
Key exclusion criteria (2 listed)
- Dementia (determined by a neuropsychological assessment)
- Severe tremor unaffected by levodopa
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between motion sensor features and clinician-rated dyskinesia severity
Time frame: All data will be collected within a single session not to exceed 3 hours
Motor function (movement speed and magnitude measured with a motion sensor) will be collected for a period of 2 hours after taking normally prescribed dose of levodopa.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 2 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 4 inclusion and 2 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 2 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?
Correlation between motion sensor features and clinician-rated dyskinesia severity (time frame: All data will be collected within a single session not to exceed 3 hours). 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.