tFUS for Memory in mNCD and Healthy Adults

NCT ID: NCT06718140

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-30
• Study Completion Date: 2027-12-01

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.

Conditions

Mild Neurocognitive Disorder; Healthy Aging

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Focused Ultrasound to Location A

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

Group Type: EXPERIMENTAL

Transcranial Focused Ultrasound

Intervention Type: DEVICE

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

Focused Ultrasound to Location B

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

Group Type: EXPERIMENTAL

Transcranial Focused Ultrasound

Intervention Type: DEVICE

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

Focused Ultrasound to Location C

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

Group Type: EXPERIMENTAL

Transcranial Focused Ultrasound

Intervention Type: DEVICE

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

Focused Ultrasound to Location D

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

Group Type: SHAM_COMPARATOR

Transcranial Focused Ultrasound

Intervention Type: DEVICE

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

Interventions

Transcranial Focused Ultrasound

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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
• 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

• 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
• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center of Neuromodulation for Rehabilitation

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Caulfield, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

Pro00135826

Identifier Type: -

Identifier Source: org_study_id