## Protocol Section
### Identification Module
**NCT ID:** NCT06426498

**Brief Title:** tFUS Induced Transient Scotoma for Individual Dosing

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

#### Organization Study ID Info
**ID:** Pro00132894
#### Organization
**Class:** OTHER
**Full Name:** Medical University of South Carolina
### Status Module
#### Completion Date
**Date:** 2025-08-20

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05-20

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Medical University of South Carolina

#### Responsible Party

**Investigator Affiliation:** Medical University of South Carolina

**Investigator Full Name:** Mark S. George

**Investigator Title:** Professor-Faculty

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Healthy

**Keywords:**

- ulltrasound

- tFUS

- scotoma

- visual field

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Masking Description:** 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.

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All subjects will get tFUS, open label

**Intervention Names:**

- Device: Brainsonix Bx Pulsar machine tFUS

**Label:** tFUS over V1

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- tFUS over V1

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

**Name:** Brainsonix Bx Pulsar machine tFUS

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Temporary Scotoma

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

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hollanbr@musc.edu

**Name:** Bridgette Holland

**Phone:** 843 638 7517

**Role:** CONTACT

**Contact 2:**

**Email:** georgem@musc.edu

**Name:** Mark S George, MD

**Phone:** 843 876 5142

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Charleston

**Contacts:**

***Contact 1:***

- **Email:** georgem@musc.edu

- **Name:** Mark S George, MD

- **Phone:** 843-876-5142

- **Role:** CONTACT

***Contact 2:***

- **Email:** shorteb@musc.edu

- **Name:** Baron E Short, MD

- **Phone:** 843 876 5142

- **Role:** CONTACT

**Country:** United States

**Facility:** Medical University of South Carolina Brain Stimulation Division

**State:** South Carolina

**Status:** RECRUITING

**Zip:** 29425

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014786

- Term: Vision Disorders

- ID: D000012678

- Term: Sensation Disorders

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M15424

- Name: Scotoma

- Relevance: HIGH

- As Found: Scotoma

- ID: M17530

- Name: Vision Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M15490

- Name: Sensation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012607

- Term: Scotoma

### Misc Info Module

- Version Holder: 2024-05-31
