tFUS Induced Transient Scotoma for Individual Dosing

NCT06426498 | Recruiting DMC FDA Device

• 1 other identifier: Pro00132894
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this research study is to:

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

Conditions

Healthy

Keywords

ulltrasound; tFUS; scotoma; visual field

Outcome Measures

Primary Outcomes (1)

• Temporary Scotoma

  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.

  During and immediately after (10 minutes) the tFUS

Study Arms (1)

tFUS over V1

EXPERIMENTAL

All subjects will get tFUS, open label

Device: Brainsonix Bx Pulsar machine tFUS

Interventions

Brainsonix Bx Pulsar machine tFUS DEVICE

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

tFUS over V1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina Brain Stimulation Division

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Scotoma

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bridgette Holland

CONTACT

843 638 7517; hollanbr@musc.edu

Mark S George, MD

CONTACT

843 876 5142; georgem@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The device will be on either right or left V1, and the ultrasound will be cycling on or off during the session. Subjects and investigators will be masked to on/off timing and puck location.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Faculty

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 23, 2024
• Study Start: June 20, 2024
• Primary Completion: May 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)