tFUS Induced Transient Scotoma for Individual Dosing

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Device: Brainsonix Bx Pulsar machine 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bridgette Holland; Phone Number: 843 638 7517; Email: hollanbr@musc.edu
• Study Contact Backup: Name: Mark S George, MD; Phone Number: 843 876 5142; Email: georgem@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina Brain Stimulation Division
      • Contact: Mark S George, MD; Phone Number: 843-876-5142; Email: georgem@musc.edu
      • Contact: Baron E Short, MD; Phone Number: 843 876 5142; Email: shorteb@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tFUS over V1; All subjects will get tFUS, open label	Device: Brainsonix Bx Pulsar machine tFUS; This is a tFUS device, delivering ultrasound at a dose within the FDA safety guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Estimated): June 20, 2024
• Primary Completion (Estimated): May 20, 2025
• Study Completion (Estimated): August 20, 2025

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: visual field; scotoma; ulltrasound; tFUS
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Scotoma
• Other Study ID Numbers: Pro00132894

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No