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临床试验/NCT01909531
NCT01909531
Unknown
不适用

Deep Brain Stimulation (DBS) Data Base Study

St. Joseph's Hospital and Medical Center, Phoenix1 个研究点 分布在 1 个国家目标入组 5,000 人2013年4月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Parkinson's Disease
发起方
St. Joseph's Hospital and Medical Center, Phoenix
入组人数
5000
试验地点
1
主要终点
Data Comparison
最后更新
4年前

概览

简要总结

The primary goal of this study is to evaluate and compare outcomes, trends, and effectiveness of both awake and asleep Deep Brain Stimulation (DBS) surgical treatments, target selection, targeting accuracy and outcomes in patients with Parkinson's disease and Essential tremor.

详细描述

Deep Brain Stimulation (DBS) surgery is a treatment that can improve some of the motor symptoms associated with several movement disorder diseases. DBS is recommended for patients with Parkinson's disease who respond well to medication, but still experience frequent wearing off of medications with return of symptoms. Patients may also be experiencing troubling medication side effects such as dyskinesias, sleepiness, hallucinations, confusion, and behavioral/personality changes. DBS is also used for patients with Essential tremor who have undergone long trials of medication therapy and are still symptomatic. The goal of DBS surgery is to capture that best response to medication and hold it through the day. The Food and Drug Administration (FDA) approved DBS as a treatment for essential tremor in 1997 and for Parkinson's disease in 2002. The goal of DBS surgery is to improve the quality of life of patients and their families by reducing motor symptoms such as slowness, stiffness and tremor and possibly reducing medication. In order to help with our understanding of its effects, we will collect information on patients who will be undergoing or have undergone DBS surgery. St. Joseph's Hospital and Medical Center / Barrow Neurological Institute is one of only a few hospitals in the United States offering a new procedure known as asleep DBS surgery, performed under general anesthesia, as well as the traditional awake DBS procedure; therefore it is important that this new asleep surgery option be studied and compared to awake DBS surgery. Objectives include: * Comparison of data collected for both the awake and asleep DBS procedures during the pre-operative and post-operative periods including testing, diagnosis, surgical treatment, target accuracy, complications, motor function and quality of life outcomes. * Comparison of the differential effects of STN and GPi DBS on gait and balance control * Investigate the effects of DBS on the saccadic eye movements.

注册库
clinicaltrials.gov
开始日期
2013年4月
结束日期
2023年12月31日
最后更新
4年前
研究类型
Observational
性别
All

研究者

发起方
St. Joseph's Hospital and Medical Center, Phoenix
责任方
Sponsor

入排标准

入选标准

  • Clinical diagnosis for Parkinson's Disease or Essential Tremor
  • Subject has undergone DBS surgery

排除标准

  • Clinical diagnosis for Parkinson's Disease or Essential Tremor
  • Subject has not undergone DBS surgery

结局指标

主要结局

Data Comparison

时间窗: Pre-operative through 6 months post operative

Data comparison for pre-operative testing, diagnosis, surgical treatment, target accuracy, complications and outcomes for patients undergoing DBS surgery will be analyzed.

次要结局

  • Quantitative Evaluation of Balance and Gait(Pre-operative through 6 months post-operative)

研究点 (1)

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