RecruitingEarly Phase 1NCT05893186

Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder


Sponsor

University of Minnesota

Enrollment

60 participants

Start Date

May 25, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 89 Years

Inclusion Criteria6

  • 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 Criteria4

  • Neurological or musculoskeletal disorder that significantly affects gait, balance, or limb movements
  • Dementia
  • Prior stereotactic neurosurgery other than DBS for movement disorder
  • Pregnancy

Interventions

OTHERDeep Brain Stimulation, STN

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

OTHERGP 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

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NCT05893186


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