Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purposes of this research study is to:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tFUS over V1 | Experimental | All subjects will get tFUS, open label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brainsonix Bx Pulsar machine tFUS | Device | This is a tFUS device, delivering ultrasound at a dose within the FDA safety guidelines. |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bridgette Holland | Contact | 843 638 7517 | hollanbr@musc.edu | |
| Mark S George, MD | Contact | 843 876 5142 | georgem@musc.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina Brain Stimulation Division | Recruiting | Charleston | South Carolina | 29425 | United States |
Not provided
| ID | Term |
|---|---|
| D012607 | Scotoma |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |