tFUS Induced Transient Scotoma for Individual Dosing

Medical University of South Carolina (MUSC)

Status

Enrolling

Conditions

Healthy

Treatments

Device: Brainsonix Bx Pulsar machine tFUS

Study type

Interventional

Funder types

Other

Identifiers

NCT06426498

Pro00132894

Details and patient eligibility

About

The purposes of this research study is to:

Develop a technique of transcranial Focused Ultrasound Stimulation (tFUS) where meaningful effects on the brain can be easily measured.
Use this technique to measure threshold for effective tFUS in individuals.
Determine whether disruption of conscious visual detection, versus non-conscious visually-guided behavior have different thresholds for disruption with tFUS.

Full description

Transcranial focused ultrasound (tFUS) is a new noninvasive way to stimulate the brain in an awake and alert person. Investigators do not yet have an easily observable way to know whether they are in the right brain location with the correct dose for that person. Investigators wonder if they can produce a transient change in someone's visual field, called a scotoma, and whether they can use that to determine the minimum tFUS dose for that person.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female
Age 18-70
Normal or corrected-to normal vision and hearing
No neurological or psychological illness

Exclusion criteria

Diagnosis of any depressive or anxiety disorder
Diagnosis of schizophrenia or bipolar disorder
Current use of any non-prescribed psychoactive medications or drugs
Contraindication to enter the MRI environment.
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 precaution should be taken. Examples of acceptable methods of birth control for participants involved in the study include: birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant.
Inability to adhere to treatment schedule.
Initiation of new antidepressant treatment at the time of study randomization.

NOTE: There will be no exclusion based upon gender or minority status. We anticipate that at least 50% of the participants will be women. The percentage of minority participants is expected to be at least 5%. We will make vigorous attempts to increase this number by posting advertisement flyers in minority communities.

Children, prisoners, and institutionalized individuals will not be recruited, because they are beyond the scope of the objectives. Moreover, we will emphasize that participation in this study is completely voluntary. Recruitment of women and minorities has been addressed above. Non-English speaking subjects will not be recruited because they may not be able to understand instructions, which could undermine the validity of the results.