Testing noninvasive ultrasound treatment for anxiety
The Effects of Noninvasive Brain Stimulation on Mental States, Behavior, and Electrophysiology
NA · Sanmai Technologies PBC dba Sanmai · NCT06169631
This study is testing whether a new ultrasound treatment can help reduce anxiety symptoms in both healthy people and those with anxiety disorders by comparing the effects of one versus multiple treatment sessions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sanmai Technologies PBC dba Sanmai (industry) |
| Locations | 1 site (Sunnyvale, California) |
| Trial ID | NCT06169631 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of low-intensity transcranial focused ultrasound (TUS) on anxiety-related behaviors and brain activity. Participants, both healthy individuals and those diagnosed with anxiety disorders, will receive TUS targeting specific brain regions. The study aims to determine if multiple doses of TUS can produce greater reductions in anxiety symptoms compared to a single dose. Outcomes will be measured through self-reported anxiety levels and clinical assessments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a recent diagnosis of anxiety disorders.
Not a fit: Patients with a history of significant brain injury, epilepsy, or those currently using psychoactive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new noninvasive option for managing anxiety disorders.
How similar studies have performed: While the use of TUS is a novel approach, similar neuromodulation techniques have shown promise in other studies for treating mental health conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-65 years of age, as verified via photo identification with date of birth. * Should be an English speaker, as indicated by being able to read and comprehend the consent form. * Experiment 2 : Participants will be included for a past diagnosis of anxiety within the past year. Exclusion Criteria: * Smokes or uses tobacco products or any form of nicotine excessively * History of head injury with loss of consciousness for more than 5 min * Uncorrected hearing or vision impairment, including color blindness * Currently have or history of brain or mental illness judged likely to interfere with testing, including drug and/or alcohol dependence * History of epilepsy * Brain tumors * Takes medications or drugs judged likely to change brain activity, including psychoactive drugs, stimulants, benzodiazepines, and/or others * Factors that may lead to poor EEG or fNIRS recordings (e.g., hairstyle) * Inadequate sleep * Drug, alcohol or prescription drug intoxication, dependence or addiction * Pregnancy, or becoming pregnant during the course of the study * Mild cognitive impairment or impaired decision making * History of migraines * Experience with neurostimulation (which might unbind or alter the results) * Metal implants in their head or face
Where this trial is running
Sunnyvale, California
- Sanmai Technologies PBC — Sunnyvale, California, United States (RECRUITING)
Study contacts
- Principal investigator: Jay Sanguinetti, PhD — Sanmai Technologies PBC
- Study coordinator: Lisannette A Ruiz
- Email: lisannette.r@sanm.ai
- Phone: 520-343-1070
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.
Conditions: Anxiety Disorders