Gen0b for Anxiety Disorders

Overseen By Stephanie French

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sanmai Technologies PBC dba Sanmai

Must not be taking: Psychoactive drugs, stimulants

Disqualifiers: Epilepsy, Brain tumors, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how transcranial focused ultrasound (TUS) affects anxiety. Researchers aim to determine if brief, low-intensity ultrasound waves directed at the brain can alter brain activity, behavior, and thinking patterns associated with anxiety disorders. Participants will be divided into groups: one with anxiety and one without, with some undergoing additional testing. The trial seeks individuals diagnosed with anxiety in the past year who do not smoke heavily or have a history of serious head injuries. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on innovative anxiety treatments.

Will I have to stop taking my current medications?

Yes, you will need to stop taking medications or drugs that are likely to change brain activity, such as psychoactive drugs, stimulants, and benzodiazepines.

What prior data suggests that transcranial focused ultrasound (TUS) is safe for treating anxiety disorders?

Research has shown that transcranial focused ultrasound (TUS) is generally well-tolerated. Safety studies indicate that TUS is safe when used in common applications. An early study found no major safety issues when TUS was used to help reduce anxiety symptoms.

However, researchers are still examining some safety aspects, especially for new uses. TUS is non-invasive, meaning it doesn't involve surgery, which typically makes it safer. Yet, like any new treatment, ongoing monitoring for unexpected problems remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcranial Focused Ultrasound (TUS) because it offers a noninvasive way to potentially improve mental wellness and behavior, especially for those with anxiety disorders. Unlike typical treatments like medication or therapy, TUS uses sound waves to target specific brain regions, which might reduce symptoms without the side effects associated with drugs. This technique could offer quicker results and a more personalized approach, as it can be precisely aimed at the brain areas involved in anxiety. Scientists are eager to see if TUS can provide a safer, faster, and more effective alternative to existing anxiety treatments.

What evidence suggests that transcranial focused ultrasound (TUS) is effective for anxiety disorders?

Research has shown that transcranial focused ultrasound (TUS), under investigation in this trial, could help treat anxiety disorders. One study found that TUS significantly reduced anxiety symptoms, as measured by a standard anxiety scale. Another study noted that TUS improved mental health symptoms and affected brain activity. Additionally, patients with mood and anxiety disorders experienced a noticeable decrease in negative mood symptoms after TUS treatment. These findings suggest that TUS might help people with anxiety by targeting specific brain areas related to these symptoms. Participants in this trial will join different experimental groups to further explore these effects. ^{1 2 3 4 5}

Who Is on the Research Team?

Jay Sanguinetti, PhD

Principal Investigator

Sanmai Technologies PBC

Taylor Kuhn, PhD

Principal Investigator

Sanmai Technologies PBC

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who speak English and have been diagnosed with an anxiety disorder in the past year. It's not suitable for those who smoke or use nicotine, have had a significant head injury, uncorrected hearing/vision issues, certain mental illnesses, epilepsy, brain tumors, take drugs affecting brain activity or are pregnant.

Inclusion Criteria

I was diagnosed with anxiety in the last year.

Should be an English speaker, as indicated by being able to read and comprehend the consent form

Exclusion Criteria

I have had a head injury where I was unconscious for over 5 minutes.

Currently have or history of brain or mental illness judged likely to interfere with testing, including drug and/or alcohol dependence

Smokes or uses tobacco products or any form of nicotine excessively

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pulsed TUS to brain regions of interest, with EEG data collection and completion of psychological scales

1 month

Multiple visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Focused Ultrasound (TUS)

Trial Overview The study is examining the impact of a noninvasive technique called transcranial focused ultrasound (TUS) on various aspects related to anxiety disorders. This includes changes in brain activity patterns, behavior shifts and cognitive functions associated with anxiety.

How Is the Trial Designed?

Group I: Experiment 2b Experimental Treatment 1 Intervention

Experiment 2b will expand on Experiment 2a protocol with multiple visits. Each visit will consist of the same activities as Experiment 2a.

Group II: Experiment 2a Experimental Treatment 1 Intervention

Current diagnosis of anxiety disorder is required. Participants will receive an MRI. Participants will answer standardized questionnaires and other similar validated psychological scales. An ultrasound transducer will be placed on their head aimed at the brain region of interest. EEG data will be collected throughout the process. After this process, participants will answer a set of post experiment questions

Group III: Experiment 1 Experimental Treatment 1 Intervention

The study will consist of 2 groups. A: no current diagnosis of anxiety or other psychological disorders. B: Current diagnosis of anxiety disorder. Results will be analyzed within and between groups. Participants will answer standardized questionnaires and other similar validated psychological scales. An ultrasound transducer will be placed on their head aimed at the brain region of interest. EEG data will be collected throughout the process. After this process, participants will answer a set of post experiment questions.

Who Is Running the Clinical Trial?

Sanmai Technologies PBC dba Sanmai

Lead Sponsor

Trials

1

Recruited

100+

Published Research Related to This Trial

Low-intensity transcranial focused ultrasound (TUS) significantly increased motor cortex excitability in Parkinson's disease patients, as evidenced by higher TMS-elicited motor-evoked potentials (MEPs) after active stimulation compared to sham treatment.

Despite the increase in motor cortex excitability, there were no significant changes in clinical outcomes measured by the MDS-UPDRS-III scale, indicating that while a-tbTUS is a feasible neuromodulation strategy, its effects on clinical symptoms may require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated Transcranial Ultrasound Neuromodulation in Parkinson's Disease: A Pilot Study. Samuel, N., Ding, MYR., Sarica, C., et al.[2023]

Transcranial MR-guided focused ultrasound has shown promise as a safe and effective treatment for functional neurological disorders, with clinical trials demonstrating its ability to create thermal lesions.

Preclinical studies suggest that focused ultrasound can also disrupt the blood-brain barrier and provide reversible neuromodulation, indicating potential for broader therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The emerging role of transcranial magnetic resonance imaging-guided focused ultrasound in functional neurosurgery. Weintraub, D., Elias, WJ.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12570825/

A panoramic review of transcranial focused ultrasound ... In summary, tFUS has shown therapeutic potential across various neurological and psychiatric disorders (Fig. 3; Table 1). The clinical ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0278584624003129

Advances in transcranial focused ultrasound ... Animal studies have demonstrated the efficacy of tFUS in improving psychiatric symptoms and modulating neural circuits through various mechanisms, such as ...

3. nature.com nature.com/articles/s41380-025-03033-w

Low-intensity transcranial focused ultrasound amygdala ... We observed a significant reduction on our primary outcome, a general measure of negative affect symptoms in MATRDs. The effect was ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06722339

Targeted Circuit-Based Transcranial Focused Ultrasound ... This study explores the potential of transcranial ultrasound stimulation (TUS) as an innovative therapeutic approach for individuals with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11592166/

Transcranial Focused Ultrasound Neuromodulation in ... Preliminary results from an open-label pilot study showed a significant reduction in anxiety symptoms, assessed with the Hamilton Anxiety Rating ...