tFUS Induced Transient Scotoma for Individual Dosing

Last updated: July 1, 2024
Sponsor: Medical University of South Carolina
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vision Loss

Blurred Vision

Treatment

Brainsonix Bx Pulsar machine tFUS

Clinical Study ID

NCT06426498
Pro00132894
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female

  • Age 18-70

  • Normal or corrected-to normal vision and hearing

  • No neurological or psychological illness

Exclusion

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 shortterm).

  • Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or aman capable of fathering a child before, during, and/or after participationprecaution should be taken. Examples of acceptable methods of birth control forparticipants involved in the study include: birth control pills, patch, IUD, condom,sponge, diaphragm with spermicide, or avoiding sexual activity that could cause thesubject 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 Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Brainsonix Bx Pulsar machine tFUS
Phase:
Study Start date:
June 20, 2024
Estimated Completion Date:
August 20, 2025

Study 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.

Connect with a study center

  • Medical University of South Carolina Brain Stimulation Division

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

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