Parkinson Disease (PD)Early Phase 1BOG DBSNCT07835308
Bayesian Optimization of DBS for Gait
A Early Phase 1 study testing Deep Brain Stimulation in people with Parkinson Disease (PD), run by University of Minnesota at 1 site in United States.
Trial summary
This project aims to establish the feasibility of Bayesian optimization for tuning deep brain stimulation (DBS) to treat gait symptoms in Parkinson's disease (PD) patients. Our primary question is: Can Bayesian optimization of DBS achieve reproducible results within a feasible number of gait measurements? PD patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease (PD)
- What is being tested?
- Deep Brain Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Mar 2033
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Diagnosis of Parkinson's Disease
- DBS in STN or GP (bilateral or unilateral)
- At least 3 months after lead implantation
Who cannot join
- Inability to walk in the off-med, off-stimulation condition (even with safety harness)
- Gait impaired significantly by a condition other than PD, as determined by the PI
- Breaks or shorts in active contacts
- IPG battery nearing end of life (in patients with primary-cell IPGs)
- Females who are nursing or pregnant
- Diminished capacity to consent (concluded via UBACC)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Johanna Caskey, BA, 763-353-9470, caske039@umn.edu
Scott Cooper, MD, PhD
About this study
This project aims to establish the feasibility of Bayesian optimization for tuning deep brain stimulation (DBS) to treat gait symptoms in Parkinson's disease (PD) patients. Our primary question is: Can Bayesian optimization of DBS achieve reproducible results within a feasible number of gait measurements? PD patients will be enrolled who have DBS of the subthalamic nucleus (STN) or globus pallidus (GP) in whom at least 3 months have passed since activation of their neurostimulators, for stabilization of clinical stimulator settings. We will apply Bayesian optimization to derive DBS settings which maximally lengthen step length relative to the OFF DBS state.
Read the detailed description
Patients will undergo on-label DBS for the treatment of Parkinson's disease, at stimulator settings different from their usual settings, but within the FDA-approved range for this indication, based on the output of the Bayesian optimization algorithm. Test settings will be evaluated by a brief period of walking on a treadmill which captures measurements of step length. The resulting step length will be provided to the algorithm to inform the next recommended test setting. This will be repeated approximately 30 times to reach putatively optimal DBS settings.
- Conditions
- Parkinson Disease (PD)
- Being tested
- Deep Brain Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationOther
DBS within FDA-approved limits and labeling for symptoms of PD
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants will be allocated to this group for DBS stimulation within FDA-approved limits and labeling for symptoms of PD. Receives: Other: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Test
Subjects walk for one minute each on a treadmill set to match their individual overground walking speed. A forceplate measures the center of pressure trajectory from which integral software detects time and location of heel-strike and toe-off events. These events, and the treadmill speed, are used to compute step lengths.
Measured: This will be repeated approximately 30 times throughout the study visit (Day 1) on various DBS settings to reach putatively optimal DBS settings.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startDec 2026 (estimated)
- Primary completionMar 2031 (estimated)
- Study completionMar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Cooper, MD, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835308
- Sponsor's protocol ID
- NEUR-2026-34549
- Acronym
- BOG DBS
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bayesian Optimization of DBS for Gait
- ClinicalTrials.gov ID
- NCT07835308
- Acronym / sponsor ID
- BOG DBS / NEUR-2026-34549
- Conditions
- Parkinson Disease (PD)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2033 (estimated)
- First posted
- 22 Sep 2026 (actual)
- 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.
This project aims to establish the feasibility of Bayesian optimization for tuning deep brain stimulation (DBS) to treat gait symptoms in Parkinson's disease (PD) patients. Our primary question is: Can Bayesian optimization of DBS achieve reproducible results within a feasible number of gait measurements? PD patients will be enrolled who have DBS of the subthalamic nucleus (STN) or globus pallidus (GP) in whom at least 3 months have passed since activation of their neurostimulators, for stabilization of clinical stimulator settings. We will apply Bayesian optimization to derive DBS settings which maximally lengthen step length relative to the OFF DBS state.
Detailed description
Patients will undergo on-label DBS for the treatment of Parkinson's disease, at stimulator settings different from their usual settings, but within the FDA-approved range for this indication, based on the output of the Bayesian optimization algorithm. Test settings will be evaluated by a brief period of walking on a treadmill which captures measurements of step length. The resulting step length will be provided to the algorithm to inform the next recommended test setting. This will be repeated approximately 30 times to reach putatively optimal DBS settings.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Other: Deep Brain StimulationAll participants will be allocated to this group for DBS stimulation within FDA-approved limits and labeling for symptoms of PD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Parkinson's Disease
- DBS in STN or GP (bilateral or unilateral)
- At least 3 months after lead implantation
Key exclusion criteria (6 listed)
- Inability to walk in the off-med, off-stimulation condition (even with safety harness)
- Gait impaired significantly by a condition other than PD, as determined by the PI
- Breaks or shorts in active contacts
- IPG battery nearing end of life (in patients with primary-cell IPGs)
- Females who are nursing or pregnant
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 |
|---|---|---|
| Deep Brain StimulationDBS within FDA-approved limits and labeling for symptoms of PD | Other | All participants |
Primary outcome
Gait Test
Time frame: This will be repeated approximately 30 times throughout the study visit (Day 1) on various DBS settings to reach putatively optimal DBS settings.
Subjects walk for one minute each on a treadmill set to match their individual overground walking speed. A forceplate measures the center of pressure trajectory from which integral software detects time and location of heel-strike and toe-off events. These events, and the treadmill speed, are used to compute step lengths.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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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.
Scott Cooper, MD, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Deep Brain Stimulation in people with Parkinson Disease (PD), run by University of Minnesota 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 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johanna Caskey, BA (763-353-9470, caske039@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Test (time frame: This will be repeated approximately 30 times throughout the study visit (Day 1) on various DBS settings to reach putatively optimal DBS settings.). 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 28 Sep 2026.