tFUS Induced Transient Scotoma for Individual Dosing

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06426498
• Other study ID #: Pro00132894
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2024
• Est. completion date: August 20, 2025

Study information

• Verified date: June 2024
• Source: Medical University of South Carolina
• Contact: Bridgette Holland
• Phone: 843 638 7517
• Email: hollanbr[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 20, 2025
• Est. primary completion date: May 20, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Scotoma

Intervention

Device:
• Brainsonix Bx Pulsar machine tFUS
This is a tFUS device, delivering ultrasound at a dose within the FDA safety guidelines.

Locations

Country	Name	City	State
United States	Medical University of South Carolina Brain Stimulation Division	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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