tFUS for Memory in mNCD and Healthy Adults

November 19, 2025 updated by: Medical University of South Carolina

Personalized Transcranial Focused Ultrasound for Mild Neurocognitive Disorder and Healthy Aging

Dementia is an ongoing and growing public health crisis in the US and worldwide. The purpose of this study is to examine a form of noninvasive brain stimulation called transcranial focused ultrasound (tFUS) to the hippocampus with the goal of improving memory.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Dementia is an ongoing and growing public health crisis in the US and worldwide. Currently, there are an estimated 6.2 million Americans living with Alzheimer's Disease (AD) the most common form of dementia accounting for roughly 75% of cases. With a growing aging population, this number is estimated to be 13.8 million in the US and 152.8 million people worldwide by 2050 with a 14% lifetime prevalence. It is difficult to treat AD, making it critical to intervene as early as possible. Mild neurocognitive disorder (mNCD) is an early stage of memory and cognitive ability loss that is more severe than normal cognitive decline due to aging. Each year, approximately 15% of people with mNCD develop dementia, making it a critical juncture where intervention could be particularly impactful. Previous research has utilized a novel technique, called transcranial focused ultrasound (tFUS), to change brain function and has measured changes to brain activity through electroencephalography (EEG) using scalp electrodes. This study will apply tFUS to the hippocampus to examine the effects on memory in healthy adults in mNCD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Medical University of South Carolina

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for Healthy Older Adults

  • Age 50-85
  • English as a first/primary language
  • Capacity to consent
  • No Diagnosis of mNCD or dementia

Exclusion Criteria for Healthy Older Adults

  • Current substance use disorder, bipolar disorder, or schizophrenia spectrum or other psychotic diagnosis
  • Daily/weekly anticholinergic or sedative use. Stimulants may be used pending investigator review. Cholinesterase inhibitors, NMDA receptor antagonists, and antidepressants are allowed if on a stable regimen for 4 weeks prior to enrollment
  • History of significant or unstable conditions that may impact cognition, such as significant cardiac, cerebrovascular, or metabolic disease, developmental disorder, or other neurologic disease (e.g., moderate to severe TBI, seizures)
  • MRI or tFUS contraindications (e.g., metal implants, claustrophobia, conditions or treatments that lower seizure threshold, taking medications that have short half-lives)
  • Enrolled in a clinical trial or has received an investigational medication or device in the last 30 days

Inclusion Criteria for mNCD

  • Age 50-85
  • English as a first/primary language
  • Diagnosed with mNCD by a healthcare provider within the past 2 years per NIA-AA or DSM-5 criteria
  • Has ≥ 2 impaired scores within one cognitive domain OR ≥ 1 impaired score in ≥ 3 domains, where impaired score is defined as ≤ 16th percentile using demographically-corrected norms
  • Must have a co-participant (e.g., spouse, adult child, relative, sibling, cohabitor, friend, or caregiver) with at least weekly in-person contact with the participant

Exclusion Criteria for mNCD

  • Prior diagnosis of dementia or major neurocognitive disorder per NIA-AA or DSM-5 criteria, and telephone interview for cognitive status (TICS) score ≤ 22
  • Current substance use disorder, bipolar disorder, or schizophrenia spectrum or other psychotic diagnosis
  • Daily/weekly anticholinergic or sedative use. Stimulants may be used pending investigator review. Cholinesterase inhibitors, NMDA receptor antagonists, and antidepressants are allowed if on a stable regimen for 4 weeks prior to enrollment
  • History of significant or unstable conditions that may impact cognition, such as significant cardiac, cerebrovascular, or metabolic disease, developmental disorder, or other neurologic disease (e.g., moderate to severe TBI, seizures)
  • MRI or tFUS contraindications (e.g., metal implants, claustrophobia, conditions or treatments than lower seizure threshold, taking medications that have short half-lives)
  • Enrolled in a clinical trial or has received an investigational medication or device in the last 30 days

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Focused Ultrasound to Location A
Focused Ultrasound will be administered to location A as condition 1. Stimulation will last 1-10 minutes
Device: Transcranial Focused Ultrasound
Using MRI-guided targeting, we will administer focused ultrasound to one of the 4 brain locations
Experimental: Focused Ultrasound to Location B
Focused Ultrasound will be administered to location B as condition 2. Stimulation will last 1-10 minutes
Device: Transcranial Focused Ultrasound
Using MRI-guided targeting, we will administer focused ultrasound to one of the 4 brain locations
Experimental: Focused Ultrasound to Location C
Focused Ultrasound will be administered to location C as condition 3. Stimulation will last 1-10 minutes
Device: Transcranial Focused Ultrasound
Using MRI-guided targeting, we will administer focused ultrasound to one of the 4 brain locations
Sham Comparator: Focused Ultrasound to Location D
Focused Ultrasound will be administered to location D as condition 4. Stimulation will last 1-10 minutes
Device: Transcranial Focused Ultrasound
Using MRI-guided targeting, we will administer focused ultrasound to one of the 4 brain locations

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Face Name Associative Memory Task (Episodic Memory) effects
Time Frame: Pre- to post-stimulation (within approximately a 1 hour time period)
Determine the within-subject effects of tFUS on episodic memory (Face Name Associative Memory Task)
Pre- to post-stimulation (within approximately a 1 hour time period)
Electroencephalography (EEG) effects
Time Frame: Pre- to post-stimulation (within approximately a 1 hour time period)
Determine the effects of tFUS on EEG recorded from scalp electrodes from pre- to post-stimulation. The investigators will evaluate broadband effects ranging from delta (1-4Hz) to beta (25-40Hz) ranges.
Pre- to post-stimulation (within approximately a 1 hour time period)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tolerability of tFUS (self report 0-10 scale)
Time Frame: Pre- to post-stimulation (within approximately a 1 hour time period)
Ratings on a scale of 0-10 gauging the side effects of stimulation on headache, pain, and other potential side effects.
Pre- to post-stimulation (within approximately a 1 hour time period)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center of Neuromodulation for Rehabilitation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kevin Caulfield, PhD, Medical University of South Carolina

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00135826

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.

Yes

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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