Parkinson's DiseaseNCT01429207
Capturing Parkinson's Disease Medication Side Effects During Daily Activities
An observational study of Parkinson's Disease and Dyskinesia, run by Great Lakes NeuroTechnologies Inc. at 1 site in United States.
Trial summary
The purpose of the study is to test whether body-worn wireless motion sensors can measure dyskinesias (involuntary movements caused by medications) in individuals with Parkinson disease (PD) independent of voluntary activity being performed and other PD motor symptoms (e.g. tremor). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Parkinson's Disease, Dyskinesia
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to not given
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Idiopathic PD demonstrating levodopa-induced dyskinesias
Who may be able to join
- Clinical diagnosis of probable or definite idiopathic Parkinson Disease with motor fluctuations that include dyskinesias after taking their usual dose of levodopa/carbidopa
Who cannot join
- Antipsychotic medications (including quetiapine and clozapine)
- Coexisting neurologic disease such as stroke or dementia
- Lacking capacity for informed consent
- Residing in a nursing home
- comorbid non-neurologic illnesses that impacts the ability to perform the study tasks
- Implantable defibrillators
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Phase I Study: Monitoring Levodopa-Induced Dyskinesia Using Accelerometer & Gyroscope-based Motion Detection System
The purpose of the study is to test whether body-worn wireless motion sensors can measure dyskinesias (involuntary movements caused by medications) in individuals with Parkinson disease (PD) independent of voluntary activity being performed and other PD motor symptoms (e.g. tremor).
- Conditions
- Parkinson's Disease, Dyskinesia
- Keywords
- levodopa, tremor, bradykinesia, motion sensors
- Medical subject headings
- Parkinson Disease, Dyskinesias, Tremor, Hypokinesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startAug 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
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429207
- Sponsor's protocol ID
- 1R43NS071882-01A1
- Status last verified
- Jun 2012
- First submitted
- 2 Sep 2011
- Last updated
- 29 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study: Monitoring Levodopa-Induced Dyskinesia Using Accelerometer & Gyroscope-based Motion Detection System
- ClinicalTrials.gov ID
- NCT01429207
- Acronym / sponsor ID
- 1R43NS071882-01A1
- Conditions
- Parkinson's Disease, Dyskinesia
- Keywords
- levodopa, tremor, bradykinesia, motion sensors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Study start
- Aug 2011
- First posted
- 7 Sep 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 the study is to test whether body-worn wireless motion sensors can measure dyskinesias (involuntary movements caused by medications) in individuals with Parkinson disease (PD) independent of voluntary activity being performed and other PD motor symptoms (e.g. tremor).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Idiopathic PD demonstrating levodopa-induced dyskinesias
Key inclusion criteria (1 listed)
- Clinical diagnosis of probable or definite idiopathic Parkinson Disease with motor fluctuations that include dyskinesias after taking their usual dose of levodopa/carbidopa
Key exclusion criteria (6 listed)
- Antipsychotic medications (including quetiapine and clozapine)
- Coexisting neurologic disease such as stroke or dementia
- Lacking capacity for informed consent
- Residing in a nursing home
- comorbid non-neurologic illnesses that impacts the ability to perform the study tasks
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
Not reported in the source record.
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 29 Jun 2012.
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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 and Dyskinesia, 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 6 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 29 Jun 2012. 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.
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 29 Jun 2012.