The Effects of Noninvasive Neuromodulation on Mental Wellness, Behavior, and Electrophysiology

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

Trial Summary

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 data supports the effectiveness of the treatment Transcranial Focused Ultrasound (TUS)?

Research shows that Transcranial Focused Ultrasound (TUS) has been effective in treating conditions like Parkinson's disease and essential tremor by targeting specific brain areas without affecting nearby tissues. It has also been used to alter pain thresholds and is being explored for other neurological conditions, indicating its potential effectiveness. ^{1 2 3 4 5}

How does Transcranial Focused Ultrasound (TUS) differ from other treatments?

Transcranial Focused Ultrasound (TUS) is unique because it is a non-invasive brain stimulation method that offers high spatial precision and can target deep brain areas, unlike many other treatments. It uses focused sound waves to stimulate specific brain regions, which is different from traditional methods that may not reach deep brain structures. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial is testing whether using sound waves on the brain can help reduce anxiety. It includes both healthy people and those with anxiety disorders to see if the treatment is effective. The study will compare the effects of different numbers of treatments.

Research Team

Jay Sanguinetti, PhD

Principal Investigator

Sanmai Technologies PBC

Taylor Kuhn, PhD

Principal Investigator

Sanmai Technologies PBC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Accelerated Transcranial Ultrasound Neuromodulation in Parkinson's Disease: A Pilot Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Sonication of the anterior thalamus with MRI-Guided transcranial focused ultrasound (tFUS) alters pain thresholds in healthy adults: A double-blind, sham-controlled study. [2021]

3. Italy pubmed.ncbi.nlm.nih.gov

Current and future uses of transcranial focused ultrasound in neurosurgery. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Can transcranial ultrasonication increase recanalization flow with tissue plasminogen activator? [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The emerging role of transcranial magnetic resonance imaging-guided focused ultrasound in functional neurosurgery. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Transcranial ultrasound stimulation in humans is associated with an auditory confound that can be effectively masked. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Low-intensity transcranial ultrasound stimulation facilitates hand motor function and cortical excitability: A crossover, randomized, double blind study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Development and validation of a computational method to predict unintended auditory brainstem response during transcranial ultrasound neuromodulation in mice. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Induction of Human Motor Cortex Plasticity by Theta Burst Transcranial Ultrasound Stimulation. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

A head template for computational dose modelling for transcranial focused ultrasound stimulation. [2023]