RightFit
RecruitingEarly Phase 1

Bayesian Optimization of DBS for Gait

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a math-based method called Bayesian optimization to adjust deep brain stimulation (DBS), which uses electrical signals in the brain. It aims to help people with Parkinson’s disease take longer steps and checks whether the method gives repeatable results with a practical number of walking tests. It is for people with DBS whose device has been turned on for at least 3 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have Parkinson’s disease.
  • Have DBS in the subthalamic nucleus (STN) or globus pallidus (GP), two areas of the brain, on one or both sides.
  • Had DBS wires placed at least 3 months ago.

Who can't join

  • Cannot walk without Parkinson’s medicine and with DBS turned off, even with a safety harness.
  • Have another condition that greatly affects walking, as judged by the lead study doctor.
  • Have breaks or short circuits in the active electrical contacts of the DBS device.
  • Have a DBS device with a non-rechargeable battery that is nearly used up.
  • Are pregnant or breastfeeding.
  • Have a reduced ability to understand and agree to join the study, based on a test called UBACC.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

MN