NCT07718906尚未招募不适用
A Prospective Early Feasibility Study of Focused Ultrasound Neuromodulation for Emotional Dysregulation Due to Dementia.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Occurrence of Treatment Emergent Adverse Events
研究概览
简要总结
The purpose of this study is to see if a focused ultrasound neuromodulation can be safely and effectively used to treat symptoms of emotional dysregulation such as agitation, irritability and anxiety
详细描述
This open-label early feasibility study investigates low intensity focussed ultrasound (FUS), in participants with emotional dysregulation due to dementia. The primary objective is to test the safety and feasibility of FUS in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 45-80 years at time of enrollment.
- •Diagnosis of probable mild-stage neurodegenerative dementia, including Alzheimer's disease (AD), frontotemporal dementia (FTD, including behavioral variant and language variant), or dementia with Lewy bodies (LBD), based on established consensus clinical criteria.
- •Presence of clinically meaningful (in treatment for or recommended for the symptoms) neuropsychiatric or behavioral symptoms including but not limited to anxiety, agitation, depression, irritability, apathy, or disinhibition
- •Able to undergo MRI scanning
- •Adequate auditory and visual abilities to complete study procedures as determined by the investigator.
- •Availability of a study partner (legally authorized representative, caregiver, or family member) who has regular contact with the participant and can provide collateral information and assist with assessments.
- •Ability to provide informed consent, or assent with legally authorized representative (LAR) consent in accordance with WVU IRB policy and applicable West Virginia law. .Currently under the care of a licensed physician, psychiatrist, or neurologist, and agrees to allow communication between investigators/study staff and healthcare providers for purposes of eligibility confirmation and safety monitoring.
排除标准
- •Moderate to severe dementia (i.e., beyond mild stage).
- •Clinically significant MRI abnormality that may jeopardize participant safety, study conduct, or confound diagnostic assessments.
- •History of clinically significant neurological disorder other than the qualifying dementia diagnosis that could confound evaluation or increase risk.
- •Major psychiatric disorder that would interfere with participation or safety, including psychosis, active suicidal ideation, or severe mood/anxiety disorder requiring immediate intervention.
- •Elevated suicide risk with History of medically verified suicide attempt within the past year.
- •Use of medications that significantly lower the seizure threshold or interfere with neuromodulation safety, as determined by the study physician.
- •Use of investigational drugs or participation in another interventional clinical trial within 30 days prior to screening.
- •Any condition that, in the opinion of the investigator, would interfere with study participation, safety, or interpretation of results.
结局指标
主要结局
Occurrence of Treatment Emergent Adverse Events
时间窗: Week 12 compared to baseline
All adverse events that are related to FUS treatment will be assessed
次要结局
- Changes in Anxiety symptoms(Week 12 compared to baseline)
- Change in behavioral symptoms(Week 12 compared to baseline)
研究者
Ali Rezai
Executive Chair and Director
West Virginia University
研究点 (1)
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