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临床试验/NCT01485276
NCT01485276撤回1 期

Pilot Study of Bilateral Pedunculo-Pontine Nucleus (PPN) Deep Brain Stimulation for Patients With Parkinson Disease (PD) Who Have Persistent Gait Disturbance, Despite Bilateral Subthalamic Nucleus (STN) Deep Brain Stimulation

National Institute of Neurological Disorders and Stroke (NINDS)0 个研究点开始时间: 2011年11月8日最近更新:
适应症

试验速览

阶段
1 期
状态
撤回
主要终点
Change in the amount of time needed to complete a standardized timed up and go (TUG) study at 6 months post-surgery on stimulation

研究概览

简要总结

Background:

  • Deep brain stimulation (DBS) in the subthalamic nucleus (STN) is an approved treatment for Parkinson s disease. It stimulates a part of the brain that helps control symptoms like tremor, stiffness, and slow movements. However, many people continue to have unsteadiness and slowness while walking, trouble swallowing, and speech problems even with STN DBS. Another type of DBS focuses on a part of the brain called the pedunculopontine nucleus (PPN). PPN DBS has improved walking in some people with Parkinson's disease. Researchers want to see if combining the two types of DBS may help control symptoms better than STN DBS alone.

Objectives:

  • To see if PPN DBS can help walking, balance, speaking, and swallowing in those who already have STN DBS.
  • To study how the DBS combination affects brain function.

Eligibility:

  • Individuals with Parkinson s disease who had STN DBS surgery at least 1 year ago, but still have difficulty walking, swallowing, and speaking.

Design:

  • Participants will be screened with a physical exam and medical history. They will also have neurological tests and other tests to measure Parkinson s disease symptoms.
  • This study requires eight visits over 1 year. One of the visits will be a 9- to 10-day admission to the NIH Clinical Center for DBS surgery.
  • Participants will have PPN DBS surgery. The surgery will be done in two steps. In the first step, the leads will be placed in the brain. In the second step, 1 week later, the stimulator device will be placed in the chest or abdomen.
  • One month after the surgery, participants will have a study visit to program the PPN DBS device to find settings that will improve walking and balance.
  • Participants will have study visits 2, 3, 6, and 12 months after surgery. Each visit will be used to check the stimulators and make any adjustments needed to try to improve walking and balance or to lessen side effects. Participants will have tests of walking and balance, speech, and swallowing. Some tests will be done with different combinations of the stimulators on or off to see the effects of each set of stimulators.

详细描述

OBJECTIVE:

  1. Determine if bilateral Pedunculo-Pontine Nucleus (PPN) Deep Brain Stimulation (DBS) will improve gait and balance problems in Parkinson Disease (PD) patients whose other disease features have responded to bilateral subthalamic nucleus (STN) DBS and medications
  2. Determine if bilateral PPN DBS will improve swallowing function in Parkinson Disease patients treated with bilateral STN DBS and medication
  3. Obtain electrophysiological data related to PPN
  4. Obtain data related to the physiological relationship of the STN and PPN

STUDY POPULATION:

Three (3) subjects with clinically diagnosed PD who have undergone bilateral STN DBS at least one year prior to enrollment, who continue to have gait and balance disturbance.

DESIGN:

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
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in the amount of time needed to complete a standardized timed up and go (TUG) study at 6 months post-surgery on stimulation

次要结局

  • TUG study at 1, 3 and 12 months post-surgery.
  • UPDRS III score and UPDRS III points 27-30 at 1, 3, 6 and 12 months
  • PDQ 31 questionnaire at 6 months
  • Swallowing function at 6 moths
  • Static and dynamic posturography parameters at 1, 3, 6 and 12 months on stimulation.

研究者

申办方类型
Nih
责任方
Sponsor

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