Recruiting

tFUS

Sponsor:

Medical University of South Carolina

Code:

NCT06426498

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Brainsonix Bx Pulsar machine tFUS

Study Details

Brief summary:

The purposes of this research study is to:

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

Conditions

Healthy

Study ID

NCT06426498

Start date

Jun 20, 2024

Status verified date

May, 2026

Completion date

Aug 20, 2027

Anticipated

Primary completion date

May 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: tFUS over V1

All subjects will get tFUS, open label

Interventions

Brainsonix Bx Pulsar machine tFUS

This is a tFUS device, delivering ultrasound at a dose within the FDA safety guidelines.

Primary outcome measure

  • Temporary Scotoma [ Time Frame: During and immediately after (10 minutes) the tFUS ]

Central Contacts and Locations

Central contacts

Locations

Medical University of South Carolina Brain Stimulation Division

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

More Information

Sponsor

Medical University of South Carolina

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • ulltrasound
  • tFUS
  • scotoma
  • visual field

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-05-29.