Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder

NCT ID: NCT05893186

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-25
• Study Completion Date: 2027-07-15

Brief 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.

Detailed Description

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Deep Brain Stimulation, STN

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

GP Deep Brain Stimulation

Intervention Type: OTHER

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

Interventions

Deep Brain Stimulation, STN

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

Intervention Type: OTHER

GP Deep Brain Stimulation

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Cooper, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Johanna Caskey, BA

Role: CONTACT

caske039@umn.edu

763-353-9470

Facility Contacts

Johanna Caskey, BA

Role: primary

caske039@umn.edu

763-353-9470

Other Identifiers

NEUR-2019-28436

Identifier Type: -

Identifier Source: org_study_id