Low-Intensity Focused Ultrasound Pulsation for Treatment of Motor Deficits in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Motor Assessment 2: 9-Hole Pegboard Dexterity Test
研究概览
简要总结
The study will test the feasibility of using Low Intensity Focused Ultrasound Pulsation (LIFUP) to treat motor symptoms in Parkinson's Disease (PD). LIFUP is a new technique that can increase brain activity in highly specific target areas and is MRI compatible. Thus, in real-time, it is possible to directly observe how LIFUP changes the brain areas important in PD by measuring its effects on brain activity, blood flow, and brain connectivity. If successful, this research will mark the first step towards a novel, non-invasive, non-medication treatment for PD.
详细描述
This trial is a proof-of-concept, proof-of-mechanism study of a novel neuromodulation technology - LIFUP - to treat motor symptoms in PD. Much like Deep Brain Stimulation, LIFUP can be focused on deep brain structures with high spatial accuracy, including those implicated in PD; however, it can do so non-invasively. Other non-invasive neuromodulation tools such as Transcranial Magnetic Stimulation can only target surface brain structures and are not optimal PD treatment tools. This study will test this new technology in 30 participants with PD during simultaneous resting state functional MRI, and collect pre- and post-LIFUP functional MRI, arterial spin labeling, motor performance data, and behavioral data, in a double-blind crossover trial to determine whether LIFUP: 1) will improve motor symptoms during and after treatment; 2) can modulate neural activity in the target brain region important for PD, the internal globus pallidus; and 3) enhance cortico-striatal motor circuit connectivity. All participants in this study will receive active ultrasound at one of the two in-person sessions and sham at the other.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
All participants complete two identical in-person testing and LIFUP sessions. At one session, the device will be used with a gel pad that allows ultrasound to pass through, and at the other session, it will be used with a gel pad that blocks the ultrasound. The order of conditions is randomized and counterbalanced across participants. The two gel pads look identical beyond a label differentiating them, and neither the participants nor the person administering ultrasound will know whether sham or active is being administered at a given session.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's disease
- •Fluent in the English language
排除标准
- •Metal implants that are not MR compatible
- •Neurological diagnosis other than Parkinson's
- •Not fluent in the English language
研究组 & 干预措施
Sham, then Active
Sham low intensity focused ultrasound pulsation (LIFUP) will be administered while participants are in the MRI scanner. Then, 2 weeks later, active LIFUP will be administered to the internal globus pallidus.
干预措施: Active LIFUP Treatment (Device)
Active, then Sham
Active Low intensity focused ultrasound pulsation (LIFUP) will be administered to the internal globus pallidus while participants are in the MRI scanner. Then, 2 weeks later, sham LIFUP will be administered.
干预措施: Active LIFUP Treatment (Device)
Active, then Sham
Active Low intensity focused ultrasound pulsation (LIFUP) will be administered to the internal globus pallidus while participants are in the MRI scanner. Then, 2 weeks later, sham LIFUP will be administered.
干预措施: Sham LIFUP Treatment (Device)
Sham, then Active
Sham low intensity focused ultrasound pulsation (LIFUP) will be administered while participants are in the MRI scanner. Then, 2 weeks later, active LIFUP will be administered to the internal globus pallidus.
干预措施: Sham LIFUP Treatment (Device)
结局指标
主要结局
Motor Assessment 2: 9-Hole Pegboard Dexterity Test
时间窗: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15
The participant will place and remove nine plastic pegs into a plastic pegboard. Scores are recorded as time in seconds that it takes the participant to complete the task with each hand. Analysis will compare pre- and post-treatment scores to quantify motor performance improvements.
Motor Assessment 1: Unified Parkinson Disease Rating Scale (UPDRS) Section 3
时间窗: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15
The participant will complete a 18-item comprehensive motor assessment that assesses elements of motor function including tremor, bradykinesia, and gait. The total score for this assessment ranges from 0 to 108 points, with higher scores indicating higher severity.
Motor Assessment 2: Finger Tapping (Score)
时间窗: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15
This task, which is item 3.4 on the Unified Parkinson's Disease Rating Scale (UPDRS), asks participants to tap their index finger on their thumb ten times as big and as fast as possible. Participants scores on item 3.4 with standard UPDRS scoring criteria (on a scale of 0 to 4, where a higher score indicates more severe Parkinson's symptoms i.e. worse performance) will be assessed pre and post-LIFUP. The scores reported below are for the hand on the side with worse symptoms (i.e. the side that LIFUP is intended to primarily affect).
Motor Assessment 2: Finger Tapping (Speed)
时间窗: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15
This task, which is item 3.4 on the Unified Parkinson's Disease Rating Scale (UPDRS), asks participants to tap their index finger on their thumb ten times as big and as fast as possible. The speed of taps will be assessed pre and post-LIFUP. Speed is calculated as \[number of taps per second\] times \[average tap amplitude\], where tap amplitude is measured on a scale of 0.0-1.0 representing the percentage of finger extension between taps, where e.g. extension to a 90 degree angle between thumb and index finger = 1.0, extension to 45 degree angle = 0.5, etc. Higher speed indicates better performance. The speed values reported below are for the hand on the side with worse symptoms (i.e. the side that LIFUP is intended to primarily affect).
次要结局
- Difference in BOLD fMRI Signal Between on vs. Off Blocks(During LIFUP (or sham) sonication on Day 1 and Day 15)
- Perfusion Changes in Internal Globus Pallidus, External Globus Pallidus, and Putamen(Pre-LIFUP and Post-LIFUP at Day 1 and Day 15)
研究者
Susan Bookheimer, PhD
Principal Investigator
University of California, Los Angeles