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RecruitingNCT07835308BOG DBSUpdated Sep 28, 2026

Bayesian Optimization of DBS for Gait

An Early Phase 1 interventional study of Deep Brain Stimulation in Parkinson Disease (PD), sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by University of Minnesota · Early Phase 1, Interventional, and Basic science

Updated Sep 28, 2026Start date movedGo to Updates ↓
Phase
Early Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 33 studies in Parkinson Disease by University of Minnesota — 17 open to participants now, 18 under way, none of them phase 3. Parkinson Disease · University of Minnesota.

Planned enrollment
15th of 21
15 · median 24
Started
2026
with 3 others
Phase 1
6 of 33
3 open now
Primary completion
2031-03
later than 17 of 17 live
Registered
33rd of 33
by date

Among the 33 studies in Parkinson Disease by University of Minnesota, this one is the 15th largest by planned enrollment of the 21 interventional ones that give a count, is one of 4 that started in 2026, is one of 6 in phase 1, reaches primary completion later than 17 of the 17 other live ones, and was the 33rd registered.

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

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Open to participants now

17 of the 33 studies in Parkinson Disease by University of Minnesota are open now, in 1 country. Recruiting first, the newest first:

11 more — sign in →

By country, each count listing its studies:

All 17 open studies →

Where they have run

Who these studies take

Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Parkinson Disease (PD)

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of Parkinson's Disease
  • DBS in STN or GP (bilateral or unilateral)
  • At least 3 months after lead implantation

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    All participants

    All participants will be allocated to this group for DBS stimulation within FDA-approved limits and labeling for symptoms of PD.

    Other: Deep Brain Stimulation

Interventions

  • OtherDeep Brain Stimulation

    DBS within FDA-approved limits and labeling for symptoms of PD

06

What researchers measure

Primary outcomes

  1. 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.

    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.

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Mar 2031, 51 months later.

Of 77 non-industry phase 1 interventional studies under Parkinson Disease, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 68. This study's planned 51 months is above that.

Counting every sponsor, half of 204 studies reached it within 19 months; a quarter within 5 and three quarters within 40.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Dec 2026, on Sep 28, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2026
First posted
Sep 22, 2026
StartEst.
Dec 2026was Sep 2026
Primary completionEst.
Mar 2031
CompletionEst.
Mar 2033
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 2026→Dec 2026
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Start date Sep 2026→Dec 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07835308
Responsible party
Sponsor
First posted
Sep 22, 2026
Start date
Dec 2026 (estimated)
Primary completion
Mar 2031 (estimated)
Completion
Mar 2033 (estimated)
Last update
Sep 28, 2026

Study contacts

Johanna Caskey, BA
Contact
caske039@umn.edu
763-353-9470
Scott Cooper, MD, PhD
principal investigator · University of Minnesota

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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