tFUS for Memory in mNCD and Healthy Adults

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Dec 4, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help improve memory for people with Mild Neurocognitive Disorder (mNCD) and healthy older adults using a technique called transcranial focused ultrasound (tFUS). This noninvasive method involves gently stimulating a part of the brain called the hippocampus, which plays a key role in memory. The study aims to see if this treatment can help people remember better, especially as they age.

To participate in this trial, you need to be between the ages of 50 and 85. If you're a healthy older adult, you should not have any memory issues or a diagnosis of dementia. Those with mNCD must have been diagnosed by a healthcare provider within the last two years and have certain memory test scores that show some impairment. Participants will need a co-participant, like a family member or friend, who can support them throughout the study. It's important to note that certain medical conditions and medications may exclude you from participating, and the study isn't actively recruiting just yet. If you do join, you can expect to undergo the tFUS treatment and participate in assessments to see how it affects your memory.

Gender

ALL

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