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Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder
NCT05893186 · University of Minnesota
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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 patient specific models that identify stimulation settings that most selectively target one pathway over other adjacent pathways. In Aim 1 (STN DBS), the comparison will be amongst settings that selectively target pedunculopallidal, pallidopeduncular and subthalamopallidal pathways. In Aim 2 (GP DBS), the comparison will be amongst settings which selectively target the pallidopeduncular pathways at its origin in GP pars interna (GPi), inhibitory afferents to GPi (from GP pars externa GPe), and pallidosubthalamic pathway (from GPe). Total time, including both test stimulation and off-stimulation time, will be about 6 hours for Arm 1, and about 5 hours for Arm 2. Testing will include quantitative measures of gait, balance, bradykinesia, and rigidity.
Eligibility criteria
Inclusion Criteria:
* Diagnosis of PD
* Bilateral DBS
* Directional DBS electrode system
* MRI, at least 7 Tesla, with diffusion tensor imaging, prior to DBS surgery
* Head CT, at least 1mm cuts, following DBS surgery
* At least 3 months since initial activation of the neurostimulator
Exclusion Criteria:
* Neurological or musculoskeletal disorder that significantly affects gait, balance, or limb movements
* Dementia
* Prior stereotactic neurosurgery other than DBS for movement disorder
* Pregnancy
Study design
Enrollment target: 60 participants
Allocation: na
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2021-05-25
Estimated completion: 2027-07-15
Last updated: 2025-09-26
Interventions
Other: Deep Brain Stimulation, STNOther: GP Deep Brain Stimulation
Primary outcomes
- • Gait test (1 minute)
Sponsor
University of Minnesota · other
Contacts & investigators
ContactJohanna Caskey, BA · contact · caske039@umn.edu · 763-353-9470
InvestigatorScott Cooper, MD, PhD · principal_investigator, University of Minnesota
All locations (1)
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States