Safety Assessment of Central Medial Thalamus Stimulation Using Transcranial Focused Ultrasound

This research study will examine the safety and tolerability of the novel, wearable device Attune ATTN201. This device uses transcranial focused ultrasound (tFUS), a form of noninvasive brain stimulation that uses sound waves to excite or inhibit the brain. The investigators research questions seek to answer how using brain imaging can guide the use of tFUS to stimulate a specific target unique to the participant's brain. This target, the Thalamus, is involved in everyday brain processing and activity. Using the participant's specific brain anatomy and tFUS, the investigators can precisely target this structure and further understand its role in the various functions. Unlike existing technologies, this device will incorporate offline usage, allowing users to comfortably wear the device out of the clinic or research setting for the first time. The unique offline guidance approach uses the participant's head shape and brain anatomy to allow for customizable and repeatable ultrasound delivery to exact, preprogrammed targets. This device will be tested over the course of 1 month per participant, and will offer insights into preparing a larger clinical trial for tFUS use.

Inclusion criteria

• Male or female
• Age 22-55
• Endorse good health with no history of mental or physical illness or implanted metal
• English as a primary language
• Capacity to consent
• Negative urine pregnancy test if a female of childbearing potential
• Willingness to adhere to the tFUS study schedule and assessments

Exclusion criteria

• Any current psychiatric diagnosis or current Clinical Global Impression ratings of psychiatric illness > 1
• Neurodevelopmental disorders, history of CNS disease, concussion, overnight hospitalization, or other neurologic sequela, tumors, seizures, meningitis, encephalitis, or abnormal CT or MRI of the brain
• Any psychotropic medication is taken within 5 half-lives of procedure time
• Any head trauma resulting in loss of consciousness
• Visual impairment (except the use of glasses)
• Inability to complete cognitive testing
• Active participation or plan for enrollment in another evidence-based clinical trial affecting the psychosocial function
• Repeated abuse or dependence upon drugs (excluding nicotine and caffeine) or taking medications including stimulants, modafinil, thyroid medication, or steroids
• Implanted devices/ferrous metal of any kind
• History of seizure or epilepsy, currently taking medications that lower seizure thresholds
• Claustrophobia or other conditions that would prevent the MRI assessment.
• Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term).

• Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a man capable of fathering a child before, during, and/or after participation precautions should be taken. Examples of acceptable methods of birth control for participants involved in the study include birth control pills, patches, IUDs, condoms, sponges, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant.
• Inability to adhere to the treatment schedule.
• Inability to fit the wearable device to the user's head.