Image-Guided DBS Programming
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Tremor severity as measured by accelerometry
研究概览
简要总结
The objective of this study is to compare the effects of image-guided programming algorithm using various image segmentations vs standard clinical programming on reduction of tremor and patient satisfaction.
详细描述
At the participant's first visit (Visit 1), their DBS device will be temporarily switched off. The investigators will then perform a baseline tremor assessment, utilizing the standard methods of an accelerometer (a device to measure acceleration of movement) and the Clinical Rating Scale for Tremor (CRST). A qualify of life assessment will also be administered using the standard Quality of Life in Essential Tremor (QUEST) questionnaire. The participant's device will first be programmed with either the image-guided programming settings or the clinical-based programming settings. Then, it will be switched to the other setting after tremor assessments are completed. Under each setting, the participant will repeat the tremor assessments via accelerometer and the CRST. This will total three tremor assessments during the visit - one for baseline, one for the first setting, and one for the second setting.
After Visit 1, the investigators will set the participant's device to one of the programming settings (either image-guided or clinical-based) at random ("Program A"). The participant will be on this setting for one week, and then the investigators will call the participant (Phone Call 1) and ask them to switch to the other setting ("Program B") for one week. After this second week, the investigators will call the participant again (Phone Call 2) and ask which setting they prefer. At that time, the participant will be free to utilize the setting they preferred for the next two weeks. The participant will then come in for their Visit 2 after four total weeks (Program A for one week, Program B for one week, and the participant's preferred setting for two weeks).
At Visit 2, the investigators will evaluate the outcomes of programming optimization. The tremor assessments will be performed again (accelerometer and CRST). The quality-of-life assessment (QUEST) will be administered as well. The investigators will also capture the participant's impression of change and overall level of satisfaction using the Patient Global Impression of Change (PGIC) scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients from 21-85 years of age
- •ET patients implanted with Boston Scientific DBS electrodes in the VIM thalamus
- •Proficiency with the English Language
- •Participant is able to comply with all testing and follow-up requirements as defined by the study protocol
- •Participant is able to provide voluntary decisionally capable, and appropriately informed consent
排除标准
- •Vulnerable populations such as children, pregnant women, or prisoners Patient is unwilling or unable to provide consent
研究组 & 干预措施
Program B
Image-guided programming
干预措施: programming b (Device)
Program A
clinical-based standard settings
干预措施: programming a (Device)
结局指标
主要结局
Tremor severity as measured by accelerometry
时间窗: 1 Month
1\. The Xsens MTw Awinda accelerometer will be used to measure tremor severity. Measurements will be taken at baseline (DBS off) and after each stimulation setting. The accelerometry data can be objectively measured by quantifying the frequency and amplitude of the tremors and has been shown to correlate with the CRST.
次要结局
- Clinical measure of tremor severity - CRST(1 month)
研究者
Casey H. Halpern, M.D.
Professor of Neurosurgery
University of Pennsylvania