tFUS for Memory in mNCD and Healthy Adults

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.

Interventions

• Transcranial Focused Ultrasound · DEVICE

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

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (1)

• Medical University of South Carolina, Charleston, South Carolina