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RecruitingNCT06169631Updated Dec 13, 2023

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

An interventional study of Gen0b in Anxiety Disorders, sponsored by Sanmai Technologies PBC dba Sanmai. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-13.

Sponsored by Sanmai Technologies PBC dba Sanmai · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
  • Registered 7 months after the study started (first participant enrolled Apr 2023, registered Dec 2023).
  • Started Apr 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

The purpose of the study is to test the effects of brief, low-intensity transcranial focused ultrasound (TUS) on electrophysiological, behavioral, and cognitive markers related to anxiety disorders.

Read the detailed description

We will test the effects of TUS on self-reported and clinical anxiety states in healthy participants and in those with diagnosed anxiety disorders. Participants in these studies will receive pulsed TUS to the brain regions of interest. We will test whether multiple doses of TUS lead to larger reductions in mental states related to anxiety in comparison to a single dose of TUS.

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Conditions studied

  • Anxiety Disorders

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In context

Anxiety Disorders

4,874 studies on the registry are indexed under Anxiety Disorders; 1,394 are open to participants now.

This study's planned enrollment of 100 is above the median of 80 across 4,180 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Sanmai Technologies PBC dba Sanmai is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Experiment 1

    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.

    Device: Gen0b

  • Experimental
    Experiment 2a

    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

    Device: Gen0b

  • Experimental
    Experiment 2b

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

    Device: Gen0b

Interventions

  • DeviceGen0b

    The ultrasound will be administered to the brain region of interest.

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What researchers measure

Primary outcomes

  1. Hamilton Anxiety Rating Inventory

    Psychological questionnaire used by clinicians to rate the severity of a patient's anxiety

    Time frame: 1 month

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Study locations

1 of 1 sites recruiting
  • Sanmai Technologies PBC
    Sunnyvale, California 94087, United States
    • Christina Le · Contact · christina.l@sanm.ai · 619-765-4786
    • Jay Sanguinetti, PhD · Principal investigator
    • Sharena Rice, PhD · Sub investigator
    Recruiting
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References and documents

Publications

  • Tyler WJ. Noninvasive neuromodulation with ultrasound? A continuum mechanics hypothesis. Neuroscientist. 2011 Feb;17(1):25-36. doi: 10.1177/1073858409348066. Epub 2010 Jan 25. PubMed 20103504 ↗
  • Kubanek J. Neuromodulation with transcranial focused ultrasound. Neurosurg Focus. 2018 Feb;44(2):E14. doi: 10.3171/2017.11.FOCUS17621. PubMed 29385924 ↗
  • Fini M, Tyler WJ. Transcranial focused ultrasound: a new tool for non-invasive neuromodulation. Int Rev Psychiatry. 2017 Apr;29(2):168-177. doi: 10.1080/09540261.2017.1302924. Epub 2017 Apr 21. PubMed 28430535 ↗
  • Legon W, Bansal P, Tyshynsky R, Ai L, Mueller JK. Transcranial focused ultrasound neuromodulation of the human primary motor cortex. Sci Rep. 2018 Jul 3;8(1):10007. doi: 10.1038/s41598-018-28320-1. PubMed 29968768 ↗
  • Tufail Y, Matyushov A, Baldwin N, Tauchmann ML, Georges J, Yoshihiro A, Tillery SI, Tyler WJ. Transcranial pulsed ultrasound stimulates intact brain circuits. Neuron. 2010 Jun 10;66(5):681-94. doi: 10.1016/j.neuron.2010.05.008. PubMed 20547127 ↗
  • Sanguinetti JL, Hameroff S, Smith EE, Sato T, Daft CMW, Tyler WJ, Allen JJB. Transcranial Focused Ultrasound to the Right Prefrontal Cortex Improves Mood and Alters Functional Connectivity in Humans. Front Hum Neurosci. 2020 Feb 28;14:52. doi: 10.3389/fnhum.2020.00052. eCollection 2020. PubMed 32184714 ↗
  • Hameroff S, Trakas M, Duffield C, Annabi E, Gerace MB, Boyle P, Lucas A, Amos Q, Buadu A, Badal JJ. Transcranial ultrasound (TUS) effects on mental states: a pilot study. Brain Stimul. 2013 May;6(3):409-15. doi: 10.1016/j.brs.2012.05.002. Epub 2012 May 29. PubMed 22664271 ↗
  • Smith EE, Reznik SJ, Stewart JL, Allen JJ. Assessing and conceptualizing frontal EEG asymmetry: An updated primer on recording, processing, analyzing, and interpreting frontal alpha asymmetry. Int J Psychophysiol. 2017 Jan;111:98-114. doi: 10.1016/j.ijpsycho.2016.11.005. Epub 2016 Nov 17. PubMed 27865882 ↗
  • Kuhn T, Spivak NM, Dang BH, Becerra S, Halavi SE, Rotstein N, Rosenberg BM, Hiller S, Swenson A, Cvijanovic L, Dang N, Sun M, Kronemyer D, Berlow R, Revett MR, Suthana N, Monti MM, Bookheimer S. Transcranial focused ultrasound selectively increases perfusion and modulates functional connectivity of deep brain regions in humans. Front Neural Circuits. 2023 Apr 5;17:1120410. doi: 10.3389/fncir.2023.1120410. eCollection 2023. PubMed 37091318 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06169631
Lead sponsor
Sanmai Technologies PBC dba Sanmai
Responsible party
Sponsor
First posted
Dec 13, 2023
Start date
Apr 29, 2023
Primary completion
Mar 2024 (estimated)
Completion
Apr 2024 (estimated)
Last update
Dec 13, 2023

Study contacts

Lisannette A Ruiz
Contact
lisannette.r@sanm.ai
520-343-1070
Stephanie French
Contact
stephanie.f@sanm.ai
650-417-8675
Jay Sanguinetti, PhD
principal investigator · Sanmai Technologies PBC
Taylor Kuhn, PhD
principal investigator · Sanmai Technologies PBC

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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