Clinical trial NCT06169631: The Effects of Noninvasive Neuromodulation on Mental Wellness, Behavior, and Electrophysiology
Official title: The Effects of Noninvasive Brain Stimulation on Mental States, Behavior, and Electrophysiology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Lead sponsor: Sanmai Technologies PBC dba Sanmai
Sponsor class: INDUSTRY
First posted: 2023-12-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Each experiment arm will have its own group(s).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hamilton Anxiety Rating Inventory
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sunnyvale
country: United States
facility: Sanmai Technologies PBC
state: California
Study officials:
affiliation: Sanmai Technologies PBC
name: Jay Sanguinetti, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sanmai Technologies PBC
name: Taylor Kuhn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Kubanek J. Neuromodulation with transcranial focused ultrasound. Neurosurg Focus. 2018 Feb;44(2):E14. doi: 10.3171/2017.11.FOCUS17621.
citation: 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.
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.
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.
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/fnhum.2020.00052. eCollection 2020.
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.
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.ijpsycho.2016.11.005. Epub 2016 Nov 17.
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 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.