Neuromodulation for Behavioral Changes in Neurological Disorders
A Prospective Early Feasibility Study of Focused Ultrasound Neuromodulation for Emotional Dysregulation Due to Dementia.
1 other identifier
interventional
15
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2026
CompletedFirst Posted
Study publicly available on registry
July 22, 2026
CompletedStudy Start
First participant enrolled
July 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2028
July 22, 2026
July 1, 2026
1.4 years
July 13, 2026
July 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of Treatment Emergent Adverse Events
All adverse events that are related to FUS treatment will be assessed
Week 12 compared to baseline
Secondary Outcomes (2)
Change in behavioral symptoms
Week 12 compared to baseline
Changes in Anxiety symptoms
Week 12 compared to baseline
Study Arms (1)
Treatment
EXPERIMENTALFUS Neuromodulation
Interventions
Subjects will undergo a single focused ultrasound Neuromodulation of the target brain region
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
WVU Rockefeller Neuroscience Institute
Morgantown, West Virginia, 26505, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ali Rezai
WVU Rockefeller Neuroscience Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive Chair and Director
Study Record Dates
First Submitted
July 13, 2026
First Posted
July 22, 2026
Study Start
July 25, 2026
Primary Completion (Estimated)
December 30, 2027
Study Completion (Estimated)
December 30, 2028
Last Updated
July 22, 2026
Record last verified: 2026-07