Neuromodulation for Behavioral Changes in Neurological Disorders

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Dementia
• Intervention / Treatment: Device: Focused Ultrasound

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Marton, BA; Phone Number: 304-293-5886; Email: jmarton@hsc.wvu.edu
• Study Contact Backup: Name: Marc Haut, PhD; Phone Number: 304-293-8182; Email: mhaut@hsc.wvu.edu

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • WVU Rockefeller Neuroscience Institute
      • Sub-Investigator: Marc Haut, PhD
      • Contact: Victor Finomore, PhD; Phone Number: 3042760500; Email: vfinomore@hsc.wvu.edu
      • Contact: Padma Tirumalai, PhD; Phone Number: 3042760500; Email: ptirumalai@hsc.wvu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; FUS Neuromodulation	Device: Focused Ultrasound; Subjects will undergo a single focused ultrasound Neuromodulation of the target brain region

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Treatment Emergent Adverse Events	All adverse events that are related to FUS treatment will be assessed	Week 12 compared to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in behavioral symptoms	Change in behavioral symptoms as assessed by NPI	Week 12 compared to baseline
Changes in Anxiety symptoms	Changes in Anxiety symptoms as measured by GAD-7	Week 12 compared to baseline

Collaborators and Investigators

• Sponsor: West Virginia University
• Investigators: Principal Investigator: Ali Rezai, WVU Rockefeller Neuroscience Institute

Study record dates

Study Major Dates

• Study Start (Estimated): July 25, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Neuromodulation; Focused Ultrasound
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: RNI_NMD_EDR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No