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临床试验/NCT06857851
NCT06857851招募中不适用

Optimizing Deep Brain Stimulation to Improve Visuomotor Function in Parkinson's Disease

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年2月1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
80
试验地点
1
主要终点
Eye alignment - vergence gain

研究概览

简要总结

Inability to align and refocus the eyes on the objects at different depths, i.e., vergence impairment and strabismus, frequently affects the quality of life in patients with Parkinson's disease. The investigators study aims to understand the location-specific effects of subthalamic region deep brain stimulation on vergence and strabismus by integrating the patient-specific deep brain stimulation models and high-resolution eye-tracking measures. The knowledge gained will allow the investigators to find the most beneficial stimulation location and parameters for improving binocular coordination, strabismus, and vergence while preserving the ability to treat motor symptoms in Parkinson's disease.

详细描述

The victims of very common condition Parkinson's disease (PD) are known to have tremor, rigidity, and slow movements. PD, in addition to its effects on human movements, also affects many other aspect of the brain's function. Impairment of vision is frequently seen in PD. These patients have difficulties with holding their eyes steady at a given point, seamlessly look around and read, and refocus their eyes from one image to the other while looking at objects that are at different depths. About third of the PD patients have problems coordinating the movement of two eyes together, i.e., abnormal vergence and strabismus. Latter results in disabling double vision and abnormal depth perception. Most treatment options available to PD patients are limited to their effects on tremor, stiffness, and slowness - their effects on visual function is very limited. Eye surgeries are not ideal treatment strategies for these conditions given constantly changing state of the PD brain due to its degenerative nature. Cutting edge deep brain stimulation (DBS) surgery has variable effects on the eye movements and vergence function and strabismus in PD. The goal of the investigators research program is to identify the best possible therapeutic strategy using DBS to improve vergence eye movements and strabismus in PD while continuing to offer its other benefits. The investigators multidisciplinary program has two aspects. One part of the study will examine the effects of DBS on vergence abnormalities and strabismus affecting their ability to focus at various depths. Using state of art, high-resolution, research grade ophthalmic equipment the investigators will examine fine details of how DBS alters the patients' ability to refocus and how it changes the alignment between the two eyes that can cause double vision and abnormal depth perception. Once the investigators identify these characteristic changes, the investigators will correlate them with the stimulated anatomical location within the same patient's brain determined using combination of novel computer simulations of DBS and the patient's own MRI. The knowledge gained will allow the investigators to find the ideal stimulation locations that is most beneficial to the patient for improvement in vision while continuing to offer benefits for tremor, rigidity, and slow movements.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Parkinson's disease with bilateral STN DBS
  • •Availability of pre-operative MR images (with a T1-weighted, gradient-echo sequence) and ability to get post-operative MRI or CT scans
  • •Hoehn and Yahr stage 2-4 when off medication, and a stable antiparkinsonian medication regimen and DBS parameter settings

排除标准

  • •Previous surgical therapy for Parkinson's disease (other than DBS)
  • •Clinically significant untreated depression or anxiety
  • •Clinical features suggestive of atypical parkinsonism

研究组 & 干预措施

Parkinson's disease with DBS

This is the only group. The patients in this group will have bilateral subthalamic region deep brain stimulator. They will be recruited after they are therapeutically optimized on stimulation as well as medical therapy.

结局指标

主要结局

Eye alignment - vergence gain

时间窗: One month

The investigators will measure vergence gain as one outcome measure. This measure will be calculated by measuring ratio of observed versus expected difference between the horizontal angular positions of the right and left eye as participants move gaze from far to near or vice versa.

Strabismus

时间窗: One month

The investigators will measure difference in position of right versus left eye as participants hold gaze on object of interest.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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