Parkinson's DiseaseNCT01534650
Movement Disorder Quantification Algorithm Development
An observational study of Parkinson's Disease and Essential Tremor, run by Great Lakes NeuroTechnologies Inc. at 1 site in United States.
Trial summary
The purpose of this study is to collect kinematic motion data from subjects with movement disorders such as Parkinson's disease (PD) and essential tremor (ET) to develop and validate algorithms for quantifying motor symptoms such as tremor, bradykinesia (slowed movements), dyskinesias (sudden, involuntary movements)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Essential Tremor
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jan 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of Northeastern Ohio with a movement disorder such as Parkinson's disease or essential tremor.
Who may be able to join
- Aged 18 years or older
- Clinical diagnosis of idiopathic Parkinson's disease or essential tremor
- Able to provide informed consent
Who cannot join
- Significant medical or psychiatric illness
- Not capable of following the required clinical instructions
- Serious medical conditions that compromise safety
Trial locations and contacts
1 site in 1 country.
United States1 site
Great Lakes NeuroTechnologies Inc. Movement Disorders Laboratory
Valley View, Ohio, 44125
About this study
The purpose of this study is to collect kinematic motion data from subjects with movement disorders such as Parkinson's disease (PD) and essential tremor (ET) to develop and validate algorithms for quantifying motor symptoms such as tremor, bradykinesia (slowed movements), dyskinesias (sudden, involuntary movements), gait, and balance during standardized tasks and/or activities of daily living.
- Conditions
- Parkinson's Disease, Essential Tremor
- Keywords
- motion sensors, tremor, bradykinesia, gait, balance, dyskinesia
- Medical subject headings
- Parkinson Disease, Essential Tremor, Tremor, Hypokinesia, Dyskinesias
What is being measured
The primary outcome is the main question the study is designed to answer.
Processed kinematics
Motion data collected during various motor tasks will be processed and compared to video review.
Measured: During assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2016
- Study completionJan 2016
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 17 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
- NCT01534650
- Sponsor's protocol ID
- GLNT-001
- Status last verified
- Feb 2017
- First submitted
- 14 Feb 2012
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Movement Disorder Quantification Algorithm Development
- ClinicalTrials.gov ID
- NCT01534650
- Acronym / sponsor ID
- GLNT-001
- Conditions
- Parkinson's Disease, Essential Tremor
- Keywords
- motion sensors, tremor, bradykinesia, gait, balance, dyskinesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 17 Feb 2012 (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 study is to collect kinematic motion data from subjects with movement disorders such as Parkinson's disease (PD) and essential tremor (ET) to develop and validate algorithms for quantifying motor symptoms such as tremor, bradykinesia (slowed movements), dyskinesias (sudden, involuntary movements), gait, and balance during standardized tasks and/or activities of daily living.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of Northeastern Ohio with a movement disorder such as Parkinson's disease or essential tremor.
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Clinical diagnosis of idiopathic Parkinson's disease or essential tremor
- Able to provide informed consent
Key exclusion criteria (3 listed)
- Significant medical or psychiatric illness
- Not capable of following the required clinical instructions
- Serious medical conditions that 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.
Primary outcome
Processed kinematics
Time frame: During assessment
Motion data collected during various motor tasks will be processed and compared to video review.
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 23 Feb 2017.
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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?
An observational study of Parkinson's Disease and Essential Tremor, 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 3 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 23 Feb 2017. 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?
Processed kinematics (time frame: During assessment). 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 23 Feb 2017.