NCT06169631

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

10 months

First QC Date

December 4, 2023

Last Update Submit

December 12, 2023

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

  • Hamilton Anxiety Rating Inventory

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

    1 month

Study Arms (3)

Experiment 1

EXPERIMENTAL

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

Experiment 2a

EXPERIMENTAL

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

Experiment 2b

EXPERIMENTAL

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

Gen0bDEVICE

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

Experiment 1Experiment 2aExperiment 2b

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanmai Technologies PBC

Sunnyvale, California, 94087, United States

RECRUITING

Related Publications (9)

  • 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.

    PMID: 20103504RESULT

  • Kubanek J. Neuromodulation with transcranial focused ultrasound. Neurosurg Focus. 2018 Feb;44(2):E14. doi: 10.3171/2017.11.FOCUS17621.

    PMID: 29385924RESULT

  • 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.

    PMID: 28430535RESULT

  • 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.

    PMID: 29968768RESULT

  • 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.

    PMID: 20547127RESULT

  • 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.

    PMID: 32184714RESULT

  • 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.

    PMID: 22664271RESULT

  • 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.

    PMID: 27865882RESULT

  • 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.

    PMID: 37091318RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Jay Sanguinetti, PhD

    Sanmai Technologies PBC

    PRINCIPAL INVESTIGATOR

  • Taylor Kuhn, PhD

    Sanmai Technologies PBC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisannette A Ruiz

CONTACT

520-343-1070lisannette.r@sanm.ai

Stephanie French

CONTACT

650-417-8675stephanie.f@sanm.ai

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Each experiment arm will have its own group(s).
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 13, 2023

Study Start

April 29, 2023

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)