Clinical Effects of Low-Intensity Focused Ultrasound Neuromodulation in Patients With Neurological and Psychiatric Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Neurophysiological Effects of Low-Intensity Focused Ultrasound
研究概览
简要总结
Low intensity focused ultrasound (LIFUS) has the potential to be used as a means of non-invasive neuro-modulation. To this day, the use of LIFUS is under investigation. Studies in healthy subjects have shown that application of LIFUS to the motor region of the brain can mildly decrease neuron excitability in healthy controls. The purpose of the present study is to evaluate the effects of LIFUS on brain tissue excitability in patients with movement disorders in order to elucidate the therapeutic potential of LIFUS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- 是
入选标准
- •18-85 years of age
- •Patients diagnosed with neurological disorders, (such as epilepsy, brain tumour, movement disorders) or psychiatric disorders (such as substance abuse disorder)
- •Patients undergoing medical or surgical treatment (such as DBS) for neurological disorders
排除标准
- •History of stroke
- •Comorbid dementia
- •Scored below 22 on the Montreal Cognitive Assessment (MoCA)
- •Has an implanted cardiac pacemaker or implantable cardioverter-defibrillator (ICD)
- •Presence of metal implanted in body that is contraindicated in TMS/MRI
- •Pregnancy
- •Major depression/psychiatric disorder that in the opinion of the Investigator will affect patient's understanding of study procedures and willingness to abide by all procedures during the course of the study
- •Receiving a psychotropic medication or taking recreational substances that in the opinion of the investigator will significantly affect safety of the protocol
- •Major systemic illness or infection
研究组 & 干预措施
Active LIFUS
Participants receive low-intensity focused ultrasound neuromodulation (LIFUS) targeting cortical or subcortical brain regions, with or without concurrent TMS or EEG/DBS recordings, depending on the study component.
干预措施: LIFUS (Device)
Sham LIFUS
Participants receive sham LIFUS stimulation designed to mimic the experimental condition without delivering therapeutic ultrasound energy.
干预措施: Sham LIFUS (Device)
结局指标
主要结局
Neurophysiological Effects of Low-Intensity Focused Ultrasound
时间窗: Baseline and post-intervention on Day 1
To determine whether LIFUS applied to cortical and subcortical brain regions modulates neurophysiological activity, as measured by suppression of transcranial magnetic stimulation-evoked motor evoked potentials and elicitation of local field potentials recorded from implanted deep brain stimulation devices (e.g., Medtronic Percept), following active LIFUS compared to sham stimulation.
Change in Clinical and Behavioral Function Following LIFUS
时间窗: Baseline and post-intervention on Day 1
To determine whether LIFUS stimulation produces measurable changes in clinical measures of motor function and behavior, including tremor amplitude, bradykinesia, rigidity, fine motor control, affective state, and craving-related behaviors, following active LIFUS compared to sham stimulation.
次要结局
未报告次要终点
研究者
Andres M. Lozano
Dr
University Health Network, Toronto