Neuromodulation for Behavioral Changes in Neurological Disorders

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство Focused Ultrasound
  Subjects will undergo a single focused ultrasound Neuromodulation of the target brain region

Первичные конечные точки

• Occurrence of Treatment Emergent Adverse Events [Срок оценки: Week 12 compared to baseline]

Вторичные конечные точки (2)

• Change in behavioral symptoms [Срок оценки: Week 12 compared to baseline]
• Changes in Anxiety symptoms [Срок оценки: Week 12 compared to baseline]

Критерии участия

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• WVU Rockefeller Neuroscience Institute — Morgantown

Идентификаторы

NCT: NCT07718906 · RNI_NMD_EDR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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