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Mild Neurocognitive DisorderPhase 1NCT06718140

tFUS for Memory in mNCD and Healthy Adults

A Phase 1 study testing Transcranial Focused Ultrasound in people with Mild Neurocognitive Disorder and Healthy Aging, run by Medical University of South Carolina at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Mild Neurocognitive Disorder, Healthy Aging
What is being tested?
Transcranial Focused Ultrasound
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteUnited States
Study dates
30 Mar 2025to 1 Dec 2027
Phase
Phase 1
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 50 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
  • Prior diagnosis of dementia or major neurocognitive disorder per NIA-AA or DSM-5 criteria, and telephone interview for cognitive status (TICS) score ≤ 22
Show all 11Show fewer
  • 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

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

  • Medical University of South Carolina

    Charleston, South Carolina, 29414

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Transcranial Focused Ultrasound
Keywords
Memory, Mild neurocognitive disorder, Brain stimulation
Medical subject headings
Neurocognitive Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Focused UltrasoundDevice

    Using MRI-guided targeting, we will administer focused ultrasound to one of the 4 brain locations

Study groups in NCT06718140
Study groupRoleWhat they receive
Focused Ultrasound to Location AExperimentalFocused Ultrasound will be administered to location A as condition 1. Stimulation will last 1-10 minutes
Receives: Device: Transcranial Focused Ultrasound
Focused Ultrasound to Location BExperimentalFocused Ultrasound will be administered to location B as condition 2. Stimulation will last 1-10 minutes
Receives: Device: Transcranial Focused Ultrasound
Focused Ultrasound to Location CExperimentalFocused Ultrasound will be administered to location C as condition 3. Stimulation will last 1-10 minutes
Receives: Device: Transcranial Focused Ultrasound
Focused Ultrasound to Location DSham comparatorFocused Ultrasound will be administered to location D as condition 4. Stimulation will last 1-10 minutes
Receives: Device: Transcranial Focused Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Face Name Associative Memory Task (Episodic Memory) effects

    Determine the within-subject effects of tFUS on episodic memory (Face Name Associative Memory Task)

    Measured: Pre- to post-stimulation (within approximately a 1 hour time period)

  2. Electroencephalography (EEG) effects

    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.

    Measured: Pre- to post-stimulation (within approximately a 1 hour time period)

Secondary outcomes (1)

  1. Tolerability of tFUS (self report 0-10 scale)

    Ratings on a scale of 0-10 gauging the side effects of stimulation on headache, pain, and other potential side effects.

    Measured: Pre- to post-stimulation (within approximately a 1 hour time period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2024
  2. Study start30 Mar 2025
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

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 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Crossover
Model description
Within-subject crossover between participants; each participant will receive each condition on different days in a counterbalanced order.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06718140
Sponsor's protocol ID
Pro00135826
Status last verified
Nov 2025
First submitted
11 Jun 2024
Last updated
24 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Transcranial Focused Ultrasound in people with Mild Neurocognitive Disorder and Healthy Aging, run by Medical University of South Carolina 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 9 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 24 Nov 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Face Name Associative Memory Task (Episodic Memory) effects (time frame: Pre- to post-stimulation (within approximately a 1 hour time period)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06718140.

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 24 Nov 2025.

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