Bayesian Optimization of DBS for Gait

NCT07835308 — Early Phase 1, Recruiting, 15 participants, University of Minnesota

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07835308, acronym BOG DBS
Status	Recruiting
Phase	Early Phase 1
Study type	Interventional; na, single group, masking: none, basic science
Enrollment	15 (Estimated)
Sponsor	University of Minnesota (Other)
Conditions	Parkinson Disease (PD)
Interventions	Deep Brain Stimulation (Other)
Dates	start 2026-12-01 (estimated), primary completion 2031-03-01 (estimated), completion 2033-03-01 (estimated), first posted 2026-09-22, last updated 2026-09-28
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
All participants	Experimental	Other: Deep Brain Stimulation	All participants will be allocated to this group for DBS stimulation within FDA-approved limits and labeling for symptoms of PD.

Deep Brain Stimulation (Other): DBS within FDA-approved limits and labeling for symptoms of PD

+Outcome measures

Primary outcomes

Gait Test [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.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

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)

+Locations (1)

Facility	City	Country	Status
University of Minnesota	Minneapolis, Minnesota	United States	Recruiting

+Investigators

Scott Cooper, MD, PhD, Principal investigator, University of Minnesota