Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

November 18, 2025 updated by: Ali Rezai

Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Recruiting
        • Rockefeller Neuroscience Institute at West Virginia University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuromodulation
Subjects meeting eligibility criteria will undergo Exablate low intensity focused ultrasound neuromodulation
Device: low intensity focused ultrasound (LIFU)
Subjects will undergo undergo a single LIFU 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
Time Frame: baseline and 7 and days after study procedure
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
Time Frame: baseline and 7 days after procedure
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
baseline and 7 days after procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ali Rezai

Investigators

  • Principal Investigator: Ali Rezai, MD, WVU Rockefeller Neuroscience Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

August 4, 2023

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI_NMD_AD01

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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