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Aim 3 Particle Swarm Optimization PIGD

RecruitingNAAges 18 Years - 85 YearsAllUniversity of Minnesota
NCT05934747 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In Parkinson's disease (PD) patients undergoing standard-of-care Deep Brain Stimulation (DBS) therapy, to compare the effect on Parkinson's symptoms of two different neurostimulator settings designed to differ from each other as much as possible with respect to how much they activate two different neuroanatomical structures: the axonal pathway from Globus Pallidus (GP) to Pedunculopontine Nucleus (PPN), and the axonal pathway from PPN to GP.

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📋 Eligibility rules (as published)
* Diagnosis of Parkinson's Disease * Bilateral DBS in STN or GP * At least 3 months after lead implantation * Montreal Cognitive Assessment (MoCA): MoCA=23+ OR: If MoCA score is 23 or less, UBACC will be performed to ensure capacity to consent. If UBACC results are unclear, the MacCAT-CR will be performed. Failed or unclear MacCAT-CR results will exclude the study candidate. * Between 18-85 years of age * Has undergone pre-operative 7T MRI (as part of protocol #1210M22183 or standard-of-care) and post-operative CT imaging (standard of care). 8.2 Exclusion Criteria: * Inability to walk in the off-med, off-stimulation condition (even with safety harness) * Gait impaired significantly by a condition other than PD * Breaks or shorts in active contacts * IPG battery nearing end of life (in patients with primary-cell IPGs) * Females who are nursing or pregnant
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What it tests

  • DBS
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Where

1 site
University of Minnesota
Minneapolis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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