Bayesian Optimization of DBS for Gait

NCT07835308 | Recruiting Early Phase 1

• 1 other identifier: NEUR-2026-34549
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

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.

  This will be repeated approximately 30 times throughout the study visit (Day 1) on various DBS settings to reach putatively optimal DBS settings.

Study Arms (1)

All participants

EXPERIMENTAL

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

Deep Brain Stimulation OTHER

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

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Scott Cooper, MD, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna Caskey, BA

CONTACT

763-353-9470; caske039@umn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will not be told what their DBS stimulation settings are during testing (single blind)
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 22, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2033
• Last Updated: September 28, 2026

Record last verified: 2026-09

Locations

US (1)