Clinical trial NCT05893186: Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder
Official title: Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Parkinson Disease
Keywords: Deep Brain Stimulation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Gait test
timeFrame: 1 minute
Secondary outcomes:
measure: Balance Test
timeFrame: About 1.5 seconds per trial.
measure: Bradykinesia test
timeFrame: 30 seconds
measure: Rigidity Test
timeFrame: 45 seconds
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Scott Cooper, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: