MCI - Mild Cognitive Impairment and Neuromodulation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety of LIFU in MCI patients - Report of Symptoms Assessment
研究概览
简要总结
This is a parallel, sham-controlled design of low-intensity focused ultrasound in patients with mild cognitive impairment (MCI). The study will evaluate safety, tolerability, and effects on cognitive function.
详细描述
This parallel 2 arm study is sham controlled and collected over 6 study visits. Participants will receive MRI and CT scans, LIFU neuromodulation, cognitive assessments, and questionnaires batteries to assess tolerability and functional outcomes in an MCI population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Blocked LIFU to the same brain region will be utilized during the sham condition.
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Montreal Cognitive Assessment (MoCA) scores between 18-23 inclusive, and able to consent to their own medical care.
排除标准
- •Claustrophobia
- •MRI contraindications (pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, or other implants)
- •CT contraindications (pregnancy)
- •Non-AD etiology (eg. Lewy body disease, vascular dementia, alcohol/drug related damage)
- •Taking anti-amyloid antibodies
- •Neuromod within 6 months of the study
- •History of other neurological disorder
- •Hx of head injury with LOC > 10 min
- •Active alcohol or drug dependence
研究组 & 干预措施
Real LIFU
Active Low Intensity Focused Ultrasound application
干预措施: Low intensity focused ultrasound (Device)
Sham LIFU
Blocked LIFU energy to the same brain region as the active group.
干预措施: Sham (No Treatment) (Device)
结局指标
主要结局
Safety of LIFU in MCI patients - Report of Symptoms Assessment
时间窗: Throughout study participation - about 6 months in total.
Symptom data (each possible symptom is listed \& scored on a likert scale - absent, mild, moderate, or severe. Free response section for any symptoms not listed.) collected before and during a follow-up period after LIFU application. Questionnaire data to be completed directly by the subject.
Tolerability Questionnaire Data
时间窗: 30 minutes after the intervention
Participants complete a questionnaire at the end of the study visit to query if they were uncomfortable/comfortable (on a likert scale, strongly disagree to strongly agree) during the experiment and if they would suggest the study to others. This data will be used to analyze tolerability of the study visits in this clinical population.
次要结局
- Effects on cognitive function using MoCA.(4 times over the course of study participation - which is about 6 months in total.)
研究者
Wynn Legon
Assistant Professor
Virginia Polytechnic Institute and State University