Ultrasound Neuromodulation in Essential Tremor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in tremor
研究概览
简要总结
This study is being done to test whether low-intensity focused ultrasound (LIFU) (low energy sound waves) cause temporary changes in brain activity and behavior when directed at particular parts of the brain. By targeting LIFU to the parts of the brain thought to be responsible for essential tremor (ET), and measuring any associated improvement in tremor, the investigators hope to show that LIFU can be a useful tool for studying the brain circuits responsible for tremor and other brain disorders.
详细描述
Hypothesis
Precisely targeted low-intensity focused ultrasound (LIFU) modulation of the dentatorubrothalamic tract (DRTT) results in transient improvement of essential tremor (ET). DRTT LIFU neuromodulation produces functional connectivity changes that mirror brain network changes after MR-guided high-intensity focused ultrasound (HIFU) thalamotomy.
Aims
- To determine the optimal stimulation parameters for DRTT LIFU neuromodulation: the investigators will record wrist accelerometer signals while systematically varying pulse repetition frequency, duty cycle, and acoustic intensity.
- To map network effects of DRTT LIFU neuromodulation: the investigators will record resting state fMRI (rs-fMRI) immediately after DRTT LIFU neuromodulation with the parameters most effective at reducing tremor in each patient.
Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be unaware of which focused ultrasound protocols are being applied when or whether the applied protocol is considered to be a candidate active stimulation or sham protocol.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with medically refractory tremor scheduled to undergo MR-guided high-intensity focused ultrasound (HIFU) thalamotomy to treat their tremor at UCSF.
排除标准
- •Due to the logistical complexity of performing MRI in patients with MR-conditional pacemakers (need for device and patient monitoring), patients with pacemakers will be excluded from enrollment. All other patients undergoing HIFU thalamotomy for tremor will be eligible for enrollment.
研究组 & 干预措施
To determine the most effective stimulation parameters for DRTT LIFU neuromodulation.
Investigators will record wrist accelerometer signals while participants maintain standardized postures that maximally elicit their tremor before, during, and after delivering LIFU stimulation.
干预措施: Focused Ultrasound Neuromodulation - Sham Control (Device)
To determine the most effective stimulation parameters for DRTT LIFU neuromodulation.
Investigators will record wrist accelerometer signals while participants maintain standardized postures that maximally elicit their tremor before, during, and after delivering LIFU stimulation.
干预措施: Focused ultrasound neuromodulation (Device)
Defocusing lens
This arm will be exactly the same as that of the active arm with the exception that a defocusing lens will be fitted to the ultrasound device which will cause the ultrasound energy to be dispersed rather than directed at the target structure.
干预措施: Focused Ultrasound Neuromodulation - Sham Control (Device)
结局指标
主要结局
Reduction in tremor
时间窗: For 3 minutes immediately after the application of each sonication protocol
The investigators will screen ultrasound parameters through repeated sonications within the same session (up to 25, depending on patient response) to determine which parameter set is most effective at reducing tremor in each participant as measured by wrist accelerometers (reduction in tremor power from baseline in the characteristic ET range of 4-12 Hz). Stimulation protocols will consist of 5 seconds of active stimulation followed by 10 seconds of no stimulation repeated four times (total 60 s). After each 60-s stimulation, there will be a delay of 3 minutes, during which the investigators will monitor tremor severity every 60 seconds through quantitative accelerometer recordings. If a change in tremor severity greater than 50% is found in the post-LIFU period compared to the pre-LIFU baseline, the investigators will wait until tremor returns to a level comparable to baseline before proceeding with additional stimulations.
次要结局
- Increases or decreases in functional connectivity of brain networks(20-30 minute MRI scan at the end of the 3-4 hour experimental session)