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

Anxiety Disorders Clinical Trial

Official title:

The Effects of Noninvasive Brain Stimulation on Mental States, Behavior, and Electrophysiology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06169631
• Other study ID #: Pro00064110
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2023
• Est. completion date: April 2024

Study information

• Verified date: December 2023
• Source: Sanmai Technologies PBC dba Sanmai
• Contact: Lisannette A Ruiz
• Phone: 520-343-1070
• Email: lisannette.r[@]sanm.ai
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Device:
• Gen0b
The ultrasound will be administered to the brain region of interest.

Locations

Country	Name	City	State
United States	Sanmai Technologies PBC	Sunnyvale	California

Sponsors (1)

Lead Sponsor	Collaborator
Sanmai Technologies PBC dba Sanmai

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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 — View Citation

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

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 perfus — View Citation

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. — View Citation

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/fnh — View Citation

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.ijpsy — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Anxiety Rating Inventory	Psychological questionnaire used by clinicians to rate the severity of a patient's anxiety	1 month