Using ultrasound to create temporary visual disruptions for personalized brain stimulation
Developing a Method of Adjusting the Strength of Transcranial Focused Ultrasound (tFUS) to Personalize Treatment.
This study is testing a new ultrasound technique to see how different levels of brain stimulation affect people's vision in healthy individuals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06426498 on ClinicalTrials.gov |
What this trial studies
This research focuses on developing a technique using transcranial Focused Ultrasound Stimulation (tFUS) to measure brain stimulation effects in individuals. The study aims to identify the minimum effective dose of tFUS by inducing a temporary visual field change, known as a scotoma. Researchers will assess whether different types of visual detection are affected by varying tFUS doses. The approach is noninvasive and targets healthy individuals to establish baseline measurements.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-70 with normal or corrected-to-normal vision and hearing.
Not a fit: Patients with neurological or psychological illnesses, or those currently using psychoactive medications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could lead to more personalized and effective brain stimulation therapies.
How similar studies have performed: While the use of tFUS is a novel approach, similar studies in brain stimulation have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina Brain Stimulation Division — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Bridgette Holland
- Email: hollanbr@musc.edu
- Phone: 843 638 7517
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.