No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
15 (estimated)
Sponsor
University of Minnesota · Other
Who this trial is looking for
This trial is looking for people with Parkinson's disease who have had deep brain stimulation (DBS) for at least three months. Participants will undergo measurements to help optimize their DBS settings for better walking.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Parkinson's disease
I have DBS in the subthalamic nucleus or globus pallidus
I have had my DBS leads implanted for at least 3 months
You may not be able to join if
I cannot walk without my medication or stimulation
My walking problems are due to something other than Parkinson's
I have breaks or shorts in my DBS contacts
My DBS battery is running low
I am pregnant or breastfeeding
I cannot give consent for myself
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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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…
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)
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