tFUS for Memory in mNCD and Healthy Adults

Phase 1

• Conditions: Mild Neurocognitive Disorder; Healthy Aging

• Registration Number: NCT06718140
• Lead Sponsor: Medical University of South Carolina

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.

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 Timeline

• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-12-04
• Study First Posted: 2024-12-05
• Study Start: 2025-04-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Face Name Associative Memory Task (Episodic Memory) effects	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)
Electroencephalography (EEG) effects	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.

Secondary Outcome Measures

Name	Time	Method
Tolerability of tFUS (self report 0-10 scale)	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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States