Recruiting
Early Phase 1

Bayesian Optimization

Sponsor:

University of Minnesota

Code:

NCT07835308

Conditions

Parkinson Disease (PD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Deep Brain Stimulation

Study Details

Brief 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.

Conditions

Parkinson Disease (PD)

Study ID

NCT07835308

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2033

Anticipated

Primary completion date

Mar, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Deep Brain Stimulation

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

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. ]

Central Contacts and Locations

Central contacts

Johanna Caskey, BA

763-353-9470caske039@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Johanna Caskey, BA

763-353-9470caske039@umn.edu

Principal Investigator:

Scott Cooper, MD, PhD

More Information

Sponsor

University of Minnesota

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.