tFUS for Memory in mNCD and Healthy Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial Focused Ultrasound.
- Who it may be relevant to
- Registry conditions: Mild Neurocognitive Disorder, Healthy Aging. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Personalized Transcranial Focused Ultrasound for Mild Neurocognitive Disorder and Healthy Aging
Overview
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.
Interventions
- Device Transcranial Focused Ultrasound
Using MRI-guided targeting, we will administer focused ultrasound to one of the 4 brain locations
Primary outcome measures
- Face Name Associative Memory Task (Episodic Memory) effects [Time frame: 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)]
Secondary outcome measures (1)
- Tolerability of tFUS (self report 0-10 scale) [Time frame: Pre- to post-stimulation (within approximately a 1 hour time period)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Medical University of South Carolina — Charleston
Identifiers
NCT: NCT06718140 · Pro00135826