A Prospective Early Feasibility Study of Focused Ultrasound Neuromodulation for Emotional Dysregulation Due to Dementia.
West Virginia University
Summary
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
Description
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.
Eligibility
- Age range
- 45–80 years
- Sex
- All
- Healthy volunteers
- No
* 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 abi…
Interventions
- DeviceFocused Ultrasound
Subjects will undergo a single focused ultrasound Neuromodulation of the target brain region
Location
- WVU Rockefeller Neuroscience InstituteMorgantown, West Virginia