Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder
University of Minnesota
60 participants
May 25, 2021
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
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
DBS of the STN, within FDA-approved limits and labeling, for symptoms of PD
PD with GP DBS, within FDA-approved limits and labeling, for symptoms of PD.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05893186