RecruitingEarly Phase 1NCT05893186

Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder


Sponsor

University of Minnesota

Enrollment

60 participants

Start Date

May 25, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study uses a computer algorithm to optimize the settings of deep brain stimulation (DBS) devices in Parkinson's patients who have trouble with walking and balance, aiming to find the best settings automatically. **You may be eligible if...** - You have a confirmed diagnosis of Parkinson's disease - You have had bilateral (both sides) deep brain stimulation surgery with directional electrodes - You had a high-resolution brain MRI (at least 7 Tesla) before surgery and a CT scan after surgery - It has been at least 3 months since your DBS device was first turned on **You may NOT be eligible if...** - You have another neurological or musculoskeletal condition significantly affecting your walking or balance - Your DBS system is not the directional type Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDeep Brain Stimulation, STN

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

OTHERGP Deep Brain Stimulation

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


Locations(1)

University of Minnesota

Minneapolis, Minnesota, United States

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NCT05893186


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