Study of Low-intensity Focused Ultrasound Effects on Human Memory
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Memory Task Accuracy
研究概览
简要总结
This research project is examining the effects of noninvasive brain stimulation on human memory. This study will help to better understand noninvasive brain stimulation techniques that may have the potential to aid in memory dysfunction. Subjects will undergo a magnetic resonance imaging (MRI) and a computed tomography (CT) scan, to take pictures of their brain and skull. They will receive noninvasive brain stimulation using low-intensity focused ultrasound (LIFU) sound waves, to temporarily change brain activity. Their brain signals (MRI or EEG) will be monitored to measure changes in their brain signals. Their heart rate, blood pressure, respiratory rate, eye movement and skin moisture will be monitored as well. They will complete neuropsychological batteries and memory tasks. They will complete questionnaires.
详细描述
This study employs a two-arm, sham-controlled, repeated measures design conducted across eight sessions:
Overall Structure
- Session 1: Baseline Assessment and Imaging
- Session 2-8: LIFU Stimulation *The order of Sessions 2-8 is ideally randomized to control for order effects. The study design allows for flexibility to accommodate varying levels of participant completion while maintaining scientific validity.
Detailed Session Breakdown Session 1: Baseline Assessment and Imaging
- Structural & Functional imaging: MRI and CT anatomical scans
- Administration of questionnaire battery Session 2-8: LIFU Stimulation or Sham
- Memory task performance
- Neuropsychological battery administration
- EEG recording
- Collection of physiological measures (HR, BP, RR, and EDR)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects of all ethnicities, who understand and speak English.
排除标准
- •The exclusion criteria below are regularly implemented in MRI, CT, and EEG experiments for the safety of the subjects and for data quality assurance.
- •Claustrophobia (scanning environment may be uncomfortable).
- •Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
- •Contraindications to CT: pregnancy
- •Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)
- •History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
- •History of head injury resulting in loss of consciousness for >10 minutes.
- •History of alcohol or drug dependence (through self-report).
结局指标
主要结局
Memory Task Accuracy
时间窗: up to 6 weeks
The percentage of correct responses during memory recall tasks, measured as a percentage. This metric will evaluate accuracy following LIFU stimulation compared to sham stimulation.
Memory Task Reaction Time
时间窗: up to 6 weeks
Reaction time during memory recall tasks, measured in milliseconds. This metric will assess the speed of memory recall following LIFU stimulation compared to sham stimulation.
次要结局
- Electroencephalography(EEG) Power Spectral Analysis in Targeted Brain Regions(up to 6 weeks)
- Phase-Amplitude Coupling (PAC) Index(up to 6 weeks)
- Executive Function Score(up to 6 weeks)
- Attention Score(up to 6 weeks)
- Processing Speed Score(up to 6 weeks)
研究者
Wynn Legon
Assistant Professor
Virginia Polytechnic Institute and State University