Low-Intensity Focused Ultrasound (LIFU) Neuromodulation | NCT05997030

Studies
Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

NCT05997030

Sponsor

Ali Rezai

Status

Recruiting

Last Update Posted

Nov 24, 2025Actual

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Alzheimer Disease

Interventions

low intensity focused ultrasound (LIFU)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 12, 2023Actual

Primary Completion Date

Sep 30, 2026Estimated

Completion Date

Sep 30, 2026Estimated

First Submitted Date

Aug 4, 2023

First Submission Date that Met QC Criteria

Aug 10, 2023

First Posted Date

Aug 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2025

Last Update Posted Date

Nov 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with mild cognitive impairment ( MCI) due to Alzheimer's disease.

Detailed Description

The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for MCI due to AD

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neuromodulation	Experimental	Subjects meeting eligibility criteria will undergo Exablate low intensity focused ultrasound neuromodulation	Device: low intensity focused ultrasound (LIFU)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
low intensity focused ultrasound (LIFU)	Device	Subjects will undergo undergo a single LIFU of the target brain region	Neuromodulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of Treatment Emergent Adverse Events	Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurence.	baseline and 7 and days after study procedure
Cognitive Change	Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)	baseline and 7 days after procedure

Secondary Outcomes

Measure	Description	Time Frame
Imaging Changes	Changes in brain metabolism and connectivity using PET and fMRI	baseline, 7 and 30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and non-pregnant females, aged 45-85 years
Able and willing to give informed consent
Must meet the clinical criteria for MCI due to Alzheimer's disease
If receiving concurrent treatment with an AChEI and/or memantine, has been on a stable dose for at least 45 days
Able to communicate sensations during the LIFU procedure

Exclusion Criteria:

Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small spaces (have claustrophobia).
Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain.
Participants with a history of seizure disorder.
Participants with clinically significant chronic pulmonary disorders e.g., severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area.
Participant does not speak English
Participant is pregnant or planning to be pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marc Haut, PhD	Contact	3042936276		mhaut@hsc.wvu.edu

Overall Officials

Name	Affiliation	Role
Ali Rezai, MD	WVU Rockefeller Neuroscience Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rockefeller Neuroscience Institute at West Virginia University	Recruiting	Morgantown	West Virginia	26505	United States

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases