Optimizing Parameters of Low-Intensity Focused Ultrasound for Cortical Modulation in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Safety Outcomes as Measured by the Number of Participants With a "Major Response"
研究概览
简要总结
The purpose of this research study is to find out the optimal intensity and frequency of Low Intensity Focused Ultrasound (LIFU) that is safe and tolerable in people who have had a stroke.
详细描述
Aim 1 is to determine the optimal intensity of Low Intensity Focused Ultrasound stimulation (LIFUS) in stroke patients in terms of safety. We will investigate the optimal spatial-peak temporal-average intensity/ISPTA in the range of 0(or sham) W/cm2 to 8 W/cm2. Safety will be investigated by assessing clinically detectable signs and symptoms by monitoring vital signs and surveying subjects with a questionnaire before and after each stimulation session, and additionally by detecting subclinical neuronal injury using MRI/DWI. Aim 1 requires up to 36 subjects.
Aim 2 is to determine the optimal frequency of LIFU stimulation in stroke patients in terms of cortical excitability. Stroke subjects undergo each of the 5 frequency levels (0.35 MHz; 0.5 MHz; 0.75 MHz, 1.0 MHz and 1.5 MHz) on 5 different days with at least one day washout. The intensity (ISPTA) will set up at the level that is determined from Aim 1. Cortical excitability is measured by the amplitude of motor evoked potentials (MEPs) induced by Transcranial Magnetic Stimulation (TMS) from the Abductor Pollicis Brevis (ABP) muscle of the affected side. MEPs will be recorded pre- and post-stimulation to determine the optimal intensity for maximal cortical excitability from the hemisphere where the lesion is located. Aim 2 requires 18 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 21 years old of any gender and race;
- •Clinical ischemic stroke or hemorrhagic (confirmed by CT or MRI) that occurred >= 2 months ago
- •Predominantly unilateral motor impairment with FM-UE score ≤ 62/66;
- •MEPs are inducible from a hand muscle on the affected side (i.e. Abductor Pollicis Brevis (APB) muscle).
排除标准
- •Any concomitant neurological disorder affecting arm function;
- •Documented history of severe dementia with or without medication before stroke;
- •Subject is unable to do the motor learning practice at the baseline;
- •Presence of any MRI/TMS/ultrasonic stimulation risk factors: an electrically, magnetically, or mechanically activated metal or nonmetal implant including cardiac pacemaker, intracerebral vascular clips, or any other electrically sensitive support system; non-fixed metal in any part of the body; pregnancy (the effect of TMS/ultrasonic stimulation on the fetus is unknown); no history of seizure before or after the stroke; preexisting scalp lesion or wound or bone defect or hemicraniectomy.
研究组 & 干预措施
Low Intensity Focused Ultrasonic Stimulation
There are different combinations of intensity and frequency with LIFUS
干预措施: Low Intensity Focused Ultrasonic Stimulation (Device)
Low Intensity Focused Ultrasonic Stimulation
There are different combinations of intensity and frequency with LIFUS
干预措施: Low Intensity Focused Ultrasonic Stimulation Frequency (Device)
结局指标
主要结局
Safety Outcomes as Measured by the Number of Participants With a "Major Response"
时间窗: At any point during or immediately following intervention on day of LIFUS application
A "major response" is pre-defined as having any of the following events: Second degree scalp burn; Clinical seizure; New lesion on DWI sequence of MRI scan and the lesion not explained by any other cause(s) or decreased ADC under the transducer stimulating motor cortex area; Patient discontinues from the study due to any reason.
次要结局
- Cortical Excitability as Measured by the Number of Participants Who Improved by ≥ 20% on Motor Evoked Potential (MEP) Amplitude(Immediately after ultrasonic stimulation)
- Motor Sequence Learning (MSL) as Measured by the Number of Participants Who Improved by ≥ 20% on a MSL Task(Immediately after ultrasonic stimulation)