Parkinson's DiseaseNCT02358876
BradyXplore Phase II: Bradykinesia Feature Extraction System
An observational study of Parkinson's Disease, run by Great Lakes NeuroTechnologies Inc. at 2 sites in United States.
Trial summary
Study objectives are to improve motion sensor algorithms for measuring bradykinesia in the clinic and the home, evaluate test-retest reliability of motion sensor algorithms for measuring bradykinesia compared to clinician raters, determine if participant-perceived symptom severities correlate with motion sensor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2015to Jul 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Individuals with implanted deep brain stimulation systems for treating Parkinson's disease
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease
- Has Deep Brain Stimulation Implant for Parkinson's disease
- Historical bradykinesia rating of 2 or greater on at least one of the Unified Parkinson's Disease Rating Scale (UPDRS) finger-tapping, hand-movements, and pronation-supination tasks with DBS off.
Who cannot join
- Dementia (MoCA < 25)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Cincinnati
Cincinnati, Ohio, 45267
Cleveland Clinic
Cleveland, Ohio, 44195
About this study
Study objectives are to improve motion sensor algorithms for measuring bradykinesia in the clinic and the home, evaluate test-retest reliability of motion sensor algorithms for measuring bradykinesia compared to clinician raters, determine if participant-perceived symptom severities correlate with motion sensor measures, determine if speed, amplitude, and rhythm fluctuate differentially throughout the day in individuals with implanted deep brain stimulation systems, receive feedback on the usability of Kinesia One, and evaluate Kinesia One compliance in the home.
Read the detailed description
In Clinic:
Participants will arrive at the clinic with deep brain stimulation (DBS) turned on and on any previously prescribed Parkinson's disease (PD) medication. Motion sensor units will be placed on the index finger, thumb, and wrist of the participant's more affected hand. The participant will then perform three repetitive motion tasks and two tremor evaluation tasks, each performed for 15 seconds. The tasks will include repetitive finger-tapping, hand opening-closing, and pronation-supination, as well as arms resting and arms extended. The sequence of five tasks will be repeated (10 task performances total) so that test-retest reliability can be examined.
The participant's DBS system will then be turned off. The two repetitions of five motor tasks will then be repeated 10 minutes, 20 minutes, and 30 minutes after DBS is turned off to measure the after-effects of DBS washout. During all task performances, motion data will be streamed from the motion sensors to a nearby computer for storage. The participant's hand will be videoed for subsequent clinical scoring. After each set of assessments (on and three time points after turning DBS off), participants will be asked to rate his/her "slowness of movement" on a 0-4 scale. The participant's DBS system will then be turned back on before he/she leaves the clinic.
To examine test-retest reliability, motion sensor-based scores will be compared to the clinician ratings. Videos from participants at both sites will be randomized, and presented to movement disorder neurologists for clinical rating. The clinician will be blinded to the participant's identity as much as possible by obscuring everything other than the participant's hand.
At Home:
Before data collection begins, a technician will give the participant a Kinesia One system (one motion sensor unit, inductive charge-pad, and tablet computer) to take home and train him/her on use. The movement tasks to be performed will be explained in detail to ensure the participant is familiar with them. The participant will be required to perform the tasks using the system twice independently before leaving the clinic to ensure he/she fully understands how to use the system. The time it takes the participant to independently set up the system will be recorded. The system will be used for two weeks, after which it will be returned to the clinic either in person or in a pre-paid shipping box.
During the two-week data collection, participants will perform a motor assessment three days per week (six days total). On each assessment day, assessments will be performed six times per day, spaced approximately two hours apart. All assessments will be performed with DBS turned ON. To begin each assessment, the participant will sit in front of the tablet computer. The software will guide the participant through the data collection procedure. The participant will be instructed to remove the motion sensor unit from the charge pad and place it appropriately on the index finger of the more affected hand. Software will then guide the participant through the assessment, which will consist of the three repetitive motion tasks and two tremor evaluation tasks, each performed for 15 seconds. The sequence of five tasks will be repeated a second time (10 task performances total) so that test-retest reliability can be examined. All data will be uploaded to a secure server. After each assessment, participants will enter rating corresponding to their perceived slowness of movement and Parkinson's state. Each week of paper diaries will be mailed back within three days after being completed in provided, pre-addressed and stamped envelopes.
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Deep brain stimulation, Bradykinesia
- Medical subject headings
- Parkinson Disease, Hypokinesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Kinesia One Assessments Performed
Percentage of Kinesia One assessments performed as directed
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Cincinnati, The Cleveland Clinic
- Responsible party
- Sponsor
- Investigators
- Dustin A Heldman, PhD, Principal investigator, Great Lakes NeuroTechnologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358876
- Sponsor's protocol ID
- 5R44NS065554
- Status last verified
- Aug 2016
- First submitted
- 4 Feb 2015
- Last updated
- 6 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BradyXplore Phase II: Bradykinesia Feature Extraction System
- ClinicalTrials.gov ID
- NCT02358876
- Acronym / sponsor ID
- 5R44NS065554
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Deep brain stimulation, Bradykinesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Cincinnati, The Cleveland Clinic
- Study start
- Feb 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Posted 6 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study objectives are to improve motion sensor algorithms for measuring bradykinesia in the clinic and the home, evaluate test-retest reliability of motion sensor algorithms for measuring bradykinesia compared to clinician raters, determine if participant-perceived symptom severities correlate with motion sensor measures, determine if speed, amplitude, and rhythm fluctuate differentially throughout the day in individuals with implanted deep brain stimulation systems, receive feedback on the usability of Kinesia One, and evaluate Kinesia One compliance in the home.
Detailed description
In Clinic:
Participants will arrive at the clinic with deep brain stimulation (DBS) turned on and on any previously prescribed Parkinson's disease (PD) medication. Motion sensor units will be placed on the index finger, thumb, and wrist of the participant's more affected hand. The participant will then perform three repetitive motion tasks and two tremor evaluation tasks, each performed for 15 seconds. The tasks will include repetitive finger-tapping, hand opening-closing, and pronation-supination, as well as arms resting and arms extended. The sequence of five tasks will be repeated (10 task performances total) so that test-retest reliability can be examined.
The participant's DBS system will then be turned off. The two repetitions of five motor tasks will then be repeated 10 minutes, 20 minutes, and 30 minutes after DBS is turned off to measure the after-effects of DBS washout. During all task performances, motion data will be streamed from the motion sensors to a nearby computer for storage. The participant's hand will be videoed for subsequent clinical scoring. After each set of assessments (on and three time points after turning DBS off), participants will be asked to rate his/her "slowness of movement" on a 0-4 scale. The participant's DBS system will then be turned back on before he/she leaves the clinic.
To examine test-retest reliability, motion sensor-based scores will be compared to the clinician ratings. Videos from participants at both sites will be randomized, and presented to movement disorder neurologists for clinical rating. The clinician will be blinded to the participant's identity as much as possible by obscuring everything other than the participant's hand.
At Home:
Before data collection begins, a technician will give the participant a Kinesia One system (one motion sensor unit, inductive charge-pad, and tablet computer) to take home and train him/her on use. The movement tasks to be performed will be explained in detail to ensure the participant is familiar with them. The participant will be required to perform the tasks using the system twice independently before leaving the clinic to ensure he/she fully understands how to use the system. The time it takes the participant to independently set up the system will be recorded. The system will be used for two weeks, after which it will be returned to the clinic either in person or in a pre-paid shipping box.
During the two-week data collection, participants will perform a motor assessment three days per week (six days total). On each assessment day, assessments will be performed six times per day, spaced approximately two hours apart. All assessments will be performed with DBS turned ON. To begin each assessment, the participant will sit in front of the tablet computer. The software will guide the participant through the data collection procedure. The participant will be instructed to remove the motion sensor unit from the charge pad and place it appropriately on the index finger of the more affected hand. Software will then guide the participant through the assessment, which will consist of the three repetitive motion tasks and two tremor evaluation tasks, each performed for 15 seconds. The sequence of five tasks will be repeated a second time (10 task performances total) so that test-retest reliability can be examined. All data will be uploaded to a secure server. After each assessment, participants will enter rating corresponding to their perceived slowness of movement and Parkinson's state. Each week of paper diaries will be mailed back within three days after being completed in provided, pre-addressed and stamped envelopes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with implanted deep brain stimulation systems for treating Parkinson's disease
Key inclusion criteria (3 listed)
- Diagnosis of idiopathic Parkinson's disease
- Has Deep Brain Stimulation Implant for Parkinson's disease
- Historical bradykinesia rating of 2 or greater on at least one of the Unified Parkinson's Disease Rating Scale (UPDRS) finger-tapping, hand-movements, and pronation-supination tasks with DBS off.
Key exclusion criteria (1 listed)
- Dementia (MoCA < 25)
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
Percentage of Kinesia One Assessments Performed
Time frame: Two weeks
Percentage of Kinesia One assessments performed as directed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
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 3 inclusion and 1 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 6 Oct 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?
Yes. Results are posted in the registry (first posted 6 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Kinesia One Assessments Performed (time frame: Two 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 6 Oct 2016.