Dementia
Conditions
Keywords
Neuromodulation, Focused Ultrasound
Brief 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
Detailed 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.
Interventions
DEVICEFocused Ultrasound
Subjects will undergo a single focused ultrasound Neuromodulation of the target brain region
Sponsors
West Virginia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective open label single group
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Treatment Emergent Adverse Events | Week 12 compared to baseline | All adverse events that are related to FUS treatment will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in behavioral symptoms | Week 12 compared to baseline | Change in behavioral symptoms as assessed by NPI |
| Changes in Anxiety symptoms | Week 12 compared to baseline | Changes in Anxiety symptoms as measured by GAD-7 |
Countries
United States
Contacts
CONTACTMarc Haut, PhD
CONTACTJennifer Marton, BA
PRINCIPAL_INVESTIGATORAli Rezai
WVU Rockefeller Neuroscience Institute
Outcome results
None listed