tFUS Induced Transient Scotoma for Individual Dosing

NCT ID: NCT06426498

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-20
• Study Completion Date: 2026-08-20

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.

Detailed 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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

tFUS over V1

All subjects will get tFUS, open label

Group Type: EXPERIMENTAL

Brainsonix Bx Pulsar machine tFUS

Intervention Type: DEVICE

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

Interventions

Brainsonix Bx Pulsar machine tFUS

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Mark George

Professor-Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of South Carolina Brain Stimulation Division

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Bridgette Holland

Role: CONTACT

hollanbr@musc.edu

843 638 7517

Mark S George, MD

Role: CONTACT

georgem@musc.edu

843 876 5142

Facility Contacts

Mark S George, MD

Role: primary

georgem@musc.edu

843 876 5142

Baron E Short, MD

Role: backup

shorteb@musc.edu

843 876 5142

Other Identifiers

Pro00132894

Identifier Type: -

Identifier Source: org_study_id