Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

• 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

Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Johanna Caskey, BA
caske039@umn.edu
763-353-9470
Time Frame
Start Date: 2021-05-25
Estimated Completion Date: 2027-07-15
Participants
Target number of participants: 60
Treatments
Experimental: STN DBS
Patients with implanted STN DBS leads will be allocated to this group for DBS stimulation of the STN, within FDA-approved limits and labeling, for symptoms of PD.
Experimental: GP DBS
Patients with implanted GP DBS leads will be allocated to this group for DBS stimulation of the GP, within FDA-approved limits and labeling, for symptoms of PD.
Sponsors
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov