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RECRUITING
NCT05893186
EARLY_PHASE1

Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder

Sponsor: University of Minnesota

View on ClinicalTrials.gov

Summary

Sixty patients will be enrolled in this study who are treated for Parkinson's disease (PD) with bilateral deep brain stimulation of subthalamic nucleus (STN) or globus pallidus (GP), who have a pre- operative 7 Tesla MRI including diffusion tensor imaging for tractography and a postoperative head CT for electrode localization, and in whom at least 3 months have passed since activation of their neurostimulators, for stabilization of clinical stimulator settings. Using their MRI and CT, the investigators will construct patient-specific models of electrical current spread to neuroanatomical tar- gets surrounding the electrode. Then applying nonlinear (particle swarm) optimization, patient- specific stimulator settings will be designed to maximally or minimally activate specific path- ways. In STN DBS: pedunculopallidal vs. pallidopeduncular pathways. In GP DBS: pallidopeduncular pathways at its origin in GP pars interna (GPi) vs. inhibitory afferents to GPi (from GP pars externa GPe). All stimulation falls within the the FDA-approved range for DBS for PD.

Key Details

Gender

All

Age Range

18 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2021-05-25

Completion Date

2027-07-15

Last Updated

2025-09-26

Healthy Volunteers

No

Interventions

OTHER

Deep Brain Stimulation, STN

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

OTHER

GP Deep Brain Stimulation

PD with GP DBS, within FDA-approved limits and labeling, for symptoms of PD.

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States