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临床试验/NCT05934747
NCT05934747招募中不适用

Aim 3 Particle Swarm Optimization Postural Instability Gait Disorder

University of Minnesota2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Unified Parkinson's Disease Rating Scale Movement Disorders Society revision, MDS-UPDRS

研究概览

简要总结

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.

详细描述

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. In this respect, the present protocol is similar to Protocol STUDY00008644. In fact, that protocol, and this one, cover different Aims of the same NIH-funded project. Protocol STUDY00008644 tested different neurostimulor settings for a few hours in the laboratory only; the present protocol also tests them for two weeks between laboratory testing sessions. This is essential, for several reasons. First, clinically relevant outcome measures, such as ADL (activities of dailly life) and QOL (quality of life) scales require observation for longer than a few hours in the laboratory. Second, DBS effects are not instantaneous, and prolonged observation is required to determine the full effect of neurostimulator settings. Third, we intend, if our hypothesis is confirmed (that activation of the PPN-to-GP pathway is most effective for the postural-instability / gait-disorder (PIGD) complex) to propose a clinical trial of neurostimulator settings designed to maximize activation of this pathway; the present protocol will yield data and experience essential for designing and proposing such a trial.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Parkinson's Disease
  • Bilateral DBS in STN or GP
  • At least 3 months after lead implantation
  • Montreal Cognitive Assessment (MoCA):
  • 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).

排除标准

  • 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

结局指标

主要结局

Unified Parkinson's Disease Rating Scale Movement Disorders Society revision, MDS-UPDRS

时间窗: 1 hour and 2 weeks after intiating stimulation

Difference in scores on MDS-UPDRS

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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