tFUS for Memory in mNCD and Healthy Adults

NCT06718140 | Enrolling By Invitation Phase 1 FDA Device

• 1 other identifier: Pro00135826
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Neurocognitive Disorder; Healthy Aging

Keywords

Memory; Mild neurocognitive disorder; Brain stimulation

Outcome Measures

Primary Outcomes (2)

• Face Name Associative Memory Task (Episodic Memory) effects

  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

  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 Outcomes (1)

• Tolerability of tFUS (self report 0-10 scale)

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

Study Arms (4)

Focused Ultrasound to Location A

EXPERIMENTAL

Focused Ultrasound will be administered to location A as condition 1. Stimulation will last 1-10 minutes

Device: Transcranial Focused Ultrasound

Focused Ultrasound to Location B

EXPERIMENTAL

Focused Ultrasound will be administered to location B as condition 2. Stimulation will last 1-10 minutes

Device: Transcranial Focused Ultrasound

Focused Ultrasound to Location C

EXPERIMENTAL

Focused Ultrasound will be administered to location C as condition 3. Stimulation will last 1-10 minutes

Device: Transcranial Focused Ultrasound

Focused Ultrasound to Location D

SHAM COMPARATOR

Focused Ultrasound will be administered to location D as condition 4. Stimulation will last 1-10 minutes

Device: Transcranial Focused Ultrasound

Interventions

Transcranial Focused Ultrasound DEVICE

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

Focused Ultrasound to Location A; Focused Ultrasound to Location B; Focused Ultrasound to Location C; Focused Ultrasound to Location D

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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
• 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)

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Center of Neuromodulation for Rehabilitation: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29414, United States

Location

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Kevin Caulfield, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within-subject crossover between participants; each participant will receive each condition on different days in a counterbalanced order.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: December 5, 2024
• Study Start: March 30, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)