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Neuromodulation for Behavioral Changes in Neurological Disorders

2026年7月16日 更新者:Ali Rezai、West Virginia University

A Prospective Early Feasibility Study of Focused Ultrasound Neuromodulation for Emotional Dysregulation Due to Dementia.

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

研究概览

地位

尚未招聘

条件

详细说明

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.

研究类型

介入性

注册 (估计的)

15

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • West Virginia
      • Morgantown、West Virginia、美国、26505
        • WVU Rockefeller Neuroscience Institute
        • 副研究员:
          • Marc Haut, PhD
        • 接触:
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

  • 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.

EXCLUSION CRITERIA

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Treatment
FUS Neuromodulation
Subjects will undergo a single focused ultrasound Neuromodulation of the target brain region

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Occurrence of Treatment Emergent Adverse Events
大体时间:Week 12 compared to baseline
All adverse events that are related to FUS treatment will be assessed
Week 12 compared to baseline

次要结果测量

结果测量
措施说明
大体时间
Change in behavioral symptoms
大体时间:Week 12 compared to baseline
Change in behavioral symptoms as assessed by NPI
Week 12 compared to baseline
Changes in Anxiety symptoms
大体时间:Week 12 compared to baseline
Changes in Anxiety symptoms as measured by GAD-7
Week 12 compared to baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ali Rezai、WVU Rockefeller Neuroscience Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月25日

初级完成 (估计的)

2027年12月30日

研究完成 (估计的)

2028年12月30日

研究注册日期

首次提交

2026年7月13日

首先提交符合 QC 标准的

2026年7月16日

首次发布 (实际的)

2026年7月22日

研究记录更新

最后更新发布 (实际的)

2026年7月22日

上次提交的符合 QC 标准的更新

2026年7月16日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • RNI_NMD_EDR

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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