NCT05893186 Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder
| NCT ID | NCT05893186 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Minnesota |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-05-25 |
| Primary Completion | 2029-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2021-05-25 with a primary completion date of 2029-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Scott Cooper, MD, PhD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT05893186 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05893186 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05893186 currently recruiting?
Yes, NCT05893186 is actively recruiting participants. Contact the research team at caske039@umn.edu for enrollment information.
Where is the NCT05893186 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05893186 clinical trial?
NCT05893186 is sponsored by University of Minnesota. The principal investigator is Scott Cooper, MD, PhD at University of Minnesota. The trial plans to enroll 60 participants.
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