Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder

NCT05893186 | Recruiting Early Phase 1

• 1 other identifier: NEUR-2019-28436
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• Gait test

  Subjects walk for one minute each on a treadmill set to match their individual overground walking speed. A forceplate measures the center of pressure trajectory from which integral software detects time and location of heel-strike and toe off events, and from these, plus the treadmill speed, we compute step lengths.

  1 minute

Secondary Outcomes (3)

• Balance Test

  About 1.5 seconds per trial.

• Bradykinesia test

  30 seconds

• Rigidity Test

  45 seconds

Study Arms (2)

STN DBS

EXPERIMENTAL

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.

Other: Deep Brain Stimulation, STN

GP DBS

EXPERIMENTAL

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.

Other: GP Deep Brain Stimulation

Interventions

Deep Brain Stimulation, STN OTHER

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

STN DBS

GP Deep Brain Stimulation OTHER

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

GP DBS

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Scott Cooper, MD, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna Caskey, BA

CONTACT

763-353-9470; caske039@umn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 7, 2023
• Study Start: May 25, 2021
• Primary Completion (Estimated): July 15, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

US (1)