ACTRN12624000687594尚未招募Unknown
A multi-center study to investigate the utility of biosignals recorded during deep brain stimulation in adults.
Deep Brain Stimulation Technologies0 个研究点目标入组 300 人开始时间: 2024年5月30日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •Participants are eligible to be included in the study only if all the following criteria apply:
- •Participants aged 18 years or older at the time of recruitment into the study.
- •Participants who have planned to have deep brain stimulation surgery for the first time or participants who have previously been implanted with deep brain stimulation systems who are planning to undergo revision surgery to either add a DBS system, remove, replace, or reposition any component of the DBS system.
- •Participants who are capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form
- •In addition to the above inclusion criteria, participants are eligible for the sub-study if the following criteria apply:
- •Participants who have been diagnosed with Parkinson’s disease
排除标准
- •Participants are ineligible to be included in the study if one or more of the following criteria apply:
- •Participants with dementia, or a significant psychiatric, behavioural or any other issue which, in the opinion of the investigators, might significantly compromise their ability to understand or complete the study protocol.
- •In addition to the above exclusion criteria, participants will be excluded from the sub-study if the following criteria apply:
- •Any complications from the DBS surgery (such as a malpositioned electrode) or any other issue which, in the opinion of the investigators, might compromise the participant’s ability to complete the protocol.
研究者
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