DementiaNCT07718906
Neuromodulation for Behavioral Changes in Neurological Disorders
A study testing Focused Ultrasound in people with Dementia, run by West Virginia University at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Dementia
- What is being tested?
- Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
WVU Rockefeller Neuroscience Institute
Morgantown, West Virginia, 26505
Victor Finomore, PhD, 3042760500, vfinomore@hsc.wvu.edu
Padma Tirumalai, PhD, 3042760500, ptirumalai@hsc.wvu.edu
About this study
Official title: 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
Read the 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.
- Conditions
- Dementia
- Being tested
- Focused Ultrasound
- Keywords
- Neuromodulation, Focused Ultrasound
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused UltrasoundDevice
Subjects will undergo a single focused ultrasound Neuromodulation of the target brain region
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | FUS Neuromodulation Receives: Device: Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Treatment Emergent Adverse Events
All adverse events that are related to FUS treatment will be assessed
Measured: Week 12 compared to baseline
Secondary outcomes (2)
Change in behavioral symptoms
Change in behavioral symptoms as assessed by NPI
Measured: Week 12 compared to baseline
Changes in Anxiety symptoms
Changes in Anxiety symptoms as measured by GAD-7
Measured: Week 12 compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start25 Jul 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective open label single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Rezai, West Virginia University
- Investigators
- Ali Rezai, Principal investigator, WVU Rockefeller Neuroscience Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718906
- Sponsor's protocol ID
- RNI_NMD_EDR
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Early Feasibility Study of Focused Ultrasound Neuromodulation for Emotional Dysregulation Due to Dementia.
- ClinicalTrials.gov ID
- NCT07718906
- Acronym / sponsor ID
- RNI_NMD_EDR
- Conditions
- Dementia
- Keywords
- Neuromodulation, Focused Ultrasound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 25 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective open label single group
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Focused UltrasoundFUS Neuromodulation |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused UltrasoundSubjects will undergo a single focused ultrasound Neuromodulation of the target brain region | Device | Treatment |
Primary outcome
Occurrence of Treatment Emergent Adverse Events
Time frame: Week 12 compared to baseline
All adverse events that are related to FUS treatment will be assessed
2 secondary outcomes
Change in behavioral symptoms
Time frame: Week 12 compared to baseline
Changes in Anxiety symptoms
Time frame: Week 12 compared to baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali Rezai principal investigator
WVU Rockefeller Neuroscience Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Ultrasound in people with Dementia, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Haut, PhD (304-293-8182, mhaut@hsc.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Treatment Emergent Adverse Events (time frame: Week 12 compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.