Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT05893186
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Deep Brain Stimulation, STN — OTHER
    DBS of the STN, within FDA-approved limits and labeling, for symptoms of PD
  • GP Deep Brain Stimulation — OTHER
    PD with GP DBS, within FDA-approved limits and labeling, for symptoms of PD.

Study Details

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.

Key Dates

Start date
May 25, 2021
Status verified
May 2026
Primary completion
Jul 15, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • 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.

Primary Outcome Measure

Gait test [ Time Frame: 1 minute ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Johanna Caskey, BA
[email protected]
763-353-9470
Scott Cooper, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Minneapolis, MN

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
University of Minnesota· Minneapolis, MN

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