Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06426498

tFUS Induced Transient Scotoma for Individual Dosing

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brainsonix Bx Pulsar machine tFUS

Device

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

Primary outcomes

  1. Temporary Scotoma

    Time frame: During and immediately after (10 minutes) the tFUS

    Production of a temporary Scotoma as assessed by visual field testing of briefly presented objects in different quadrants while staring at a central cross on a computer screen.

Study contacts

Contact information is provided by the study sponsor or research team.

Bridgette Holland

CONTACT

[email protected]

843 638 7517

Mark S George, MD

CONTACT

[email protected]

843 876 5142

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Developing a Method of Adjusting the Strength of Transcranial Focused Ultrasound (tFUS) to Personalize Treatment.

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 23, 2024
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.