Parkinson DiseaseDBS-ExpertNCT02765282
Automated Deep Brain Stimulation Programming Using Functional Mapping
A study testing Algorithm based programming using Kinesia-based assessment in people with Parkinson Disease, run by Great Lakes NeuroTechnologies Inc. at 3 sites in United States.
Trial summary
Participants will undergo DBS programming guided by the DBS-Expert system and by a clinician per standard care. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Algorithm based programming using Kinesia-based assessment
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2018to Jun 2020
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The ability to provide informed consent
- Clinical diagnosis of idiopathic Parkinson's disease (PD)
- Implanted deep brain stimulation (DBS) system for tremor and/or bradykinesia
Who cannot join
- Significant medical or psychiatric illness or dementia as evidenced by a score less than 26 on the Montreal Cognitive Assessment
- Not capable of functioning independently
- Individuals so symptomatic as to compromise safety
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Atrium Health
Charlotte, North Carolina, 28207
Jennifer Mabry, MT (ASCP), 704-446-1982, Jennifer.Mabry@atriumhealth.org
Danielle Englert, MD
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Amanda Luff, MPH, CCRP, 614-293-2443, Amanda.Luff@osumc.edu
Vibhor Krishna, MBBS
- Recruiting
Wake Forest University
Winston-Salem, North Carolina, 27157
Jessica Dimos, 336-716-8694, jdimos@wakehealth.edu
Ihtsham Haq, MD
About this study
Participants will undergo DBS programming guided by the DBS-Expert system and by a clinician per standard care.
- Conditions
- Parkinson Disease
- Being tested
- Algorithm based programming using Kinesia-based assessment
- Keywords
- Deep brain stimulation (DBS), Kinesia
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algorithm based programming using Kinesia-based assessmentDevice
Also called DBS-Expert
DBS-Expert includes a tablet-based software application (app) for guiding DBS programming and a Kinesia motion sensor unit for automated motor assessment. Algorithms search the programming parameter space to resolve an optimal set of programming parameters.
| Study group | Role | What they receive |
|---|---|---|
| DBS-Expert Programming First | Experimental | These patients will be undergo algorithm based programming using Kinesia-based assessment (DBS-Expert) first and then be programmed by a clinician within five days. Receives: Device: Algorithm based programming using Kinesia-based assessment |
| Traditional Programming First | Experimental | These patients will be programmed by a clinician first and then undergo algorithm based programming using Kinesia-based assessment (DBS-Expert) within five days. Receives: Device: Algorithm based programming using Kinesia-based assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Programming time when programmed using Kinesia-based assessment (DBS-Expert) compared to programming time when programmed by a clinician
Amount of time it took to arrive at DBS settings that provide sufficient therapeutic benefit will be compared across programming sessions
Measured: Up to 2 hours (from start of programming session until end of programming session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study start1 Oct 2018
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wake Forest University Health Sciences, Ohio State University, Wake Forest University
- Responsible party
- Sponsor
- Investigators
- Dustin A Heldman, PhD, Principal investigator, Great Lakes NeuroTechnologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765282
- Sponsor's protocol ID
- R44NS081902
- Acronym
- DBS-Expert
- Status last verified
- Jun 2019
- First submitted
- 27 Apr 2016
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Deep Brain Stimulation Programming Using Functional Mapping
- ClinicalTrials.gov ID
- NCT02765282
- Acronym / sponsor ID
- DBS-Expert / R44NS081902
- Conditions
- Parkinson Disease
- Keywords
- Deep brain stimulation (DBS), Kinesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Wake Forest University Health Sciences, Ohio State University, Wake Forest University
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 6 May 2016 (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.
Participants will undergo DBS programming guided by the DBS-Expert system and by a clinician per standard care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBS-Expert Programming First | Experimental | Device: Algorithm based programming using Kinesia-based assessmentThese patients will be undergo algorithm based programming using Kinesia-based assessment (DBS-Expert) first and then be programmed by a clinician within five days. |
| Traditional Programming First | Experimental | Device: Algorithm based programming using Kinesia-based assessmentThese patients will be programmed by a clinician first and then undergo algorithm based programming using Kinesia-based assessment (DBS-Expert) within five days. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The ability to provide informed consent
- Clinical diagnosis of idiopathic Parkinson's disease (PD)
- Implanted deep brain stimulation (DBS) system for tremor and/or bradykinesia
Key exclusion criteria (3 listed)
- Significant medical or psychiatric illness or dementia as evidenced by a score less than 26 on the Montreal Cognitive Assessment
- Not capable of functioning independently
- Individuals so symptomatic as to 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 |
|---|---|---|
| Algorithm based programming using Kinesia-based assessmentAlso: DBS-ExpertDBS-Expert includes a tablet-based software application (app) for guiding DBS programming and a Kinesia motion sensor unit for automated motor assessment. Algorithms search the programming parameter space to resolve an optimal set of programming parameters. | Device | DBS-Expert Programming First, Traditional Programming First |
Primary outcome
Programming time when programmed using Kinesia-based assessment (DBS-Expert) compared to programming time when programmed by a clinician
Time frame: Up to 2 hours (from start of programming session until end of programming session)
Amount of time it took to arrive at DBS settings that provide sufficient therapeutic benefit will be compared across programming sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithm based programming using Kinesia-based assessment in people with Parkinson Disease, run by Great Lakes NeuroTechnologies Inc. at 3 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 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: status not confirmed, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dustin A Heldman, PhD (2163615410, dheldman@glneurotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Programming time when programmed using Kinesia-based assessment (DBS-Expert) compared to programming time when programmed by a clinician (time frame: Up to 2 hours (from start of programming session until end of programming session)). 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 27 Jun 2019.