RecruitingNot ApplicableNCT05934747

Aim 3 Particle Swarm Optimization PIGD

Aim 3 Particle Swarm Optimization Postural Instability Gait Disorder


Sponsor

University of Minnesota

Enrollment

30 participants

Start Date

Mar 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria8

  • 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).

Exclusion Criteria5

  • 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

Interventions

DEVICEDBS

Deep Brain Stimulation


Locations(1)

University of Minnesota

Minneapolis, Minnesota, United States

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NCT05934747


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