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Focused Ultrasound for Behavioral Changes in Dementia

This study is testing a treatment called Focused Ultrasound (FUS) to see if it can safely and effectively help with emotional problems like agitation, irritability, and anxiety in people with dementia. FUS is a device that uses sound waves to target specific areas of the brain. You may be able to join if you are between 45 and 80 years old and have a diagnosis of mild-stage neurodegenerative dementia, such as Alzheimer's disease, frontotemporal dementia, or Lewy body dementia. The main goal of this study is to see if FUS is safe and practical for this group of patients. The current recruitment status is unclear, and the study plans to enroll 15 participants.

Study design
This is an open-label study, meaning both you and the study team will know you are receiving the Focused Ultrasound treatment. It is an early feasibility study and plans to enroll 15 participants.
What's involved
You will undergo a single Focused Ultrasound neuromodulation treatment to a specific brain region. The study will then monitor for any side effects for 12 weeks after the treatment.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 12 weeks after the Focused Ultrasound treatment to monitor for any adverse events.

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NCT07718906

Neuromodulation for Behavioral Changes in Neurological Disorders

Not Yet Recruiting
NAAges 45–80InterventionalTreatment
West Virginia University
~15 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Focused Ultrasound

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of Treatment Emergent Adverse Events
Measured over Week 12 compared to baseline

Conditions

Dementia

Explore related trials

Alzheimer's DiseaseFrontotemporal DementiaLewy Body Dementia

Where it's being run

1 sites across 1 states
West Virginia1

Study leadership

  • Ali Rezai · PRINCIPAL_INVESTIGATOR · WVU Rockefeller Neuroscience Institute

Who to contact

Marc Haut, PhD
[email protected]
304-293-8182
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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.

What this trial measures

  • Occurrence of Treatment Emergent Adverse EventsWeek 12 compared to baseline

    All adverse events that are related to FUS treatment will be assessed