The Effects of Noninvasive Neuromodulation on Mental Wellness, Behavior, and Electrophysiology
NCT ID: NCT06169631
Last Updated: 2023-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-04-29
2024-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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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.
Gen0b
The ultrasound will be administered to the brain region of interest.
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
Gen0b
The ultrasound will be administered to the brain region of interest.
Experiment 2b
Experiment 2b will expand on Experiment 2a protocol with multiple visits. Each visit will consist of the same activities as Experiment 2a.
Gen0b
The ultrasound will be administered to the brain region of interest.
Interventions
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Gen0b
The ultrasound will be administered to the brain region of interest.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Sanmai Technologies PBC dba Sanmai
INDUSTRY
Responsible Party
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Principal Investigators
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Jay Sanguinetti, PhD
Role: PRINCIPAL_INVESTIGATOR
Sanmai Technologies PBC
Taylor Kuhn, PhD
Role: PRINCIPAL_INVESTIGATOR
Sanmai Technologies PBC
Locations
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Sanmai Technologies PBC
Sunnyvale, California, United States
Countries
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Central Contacts
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Facility Contacts
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Christina Le
Role: primary
References
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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.
Kubanek J. Neuromodulation with transcranial focused ultrasound. Neurosurg Focus. 2018 Feb;44(2):E14. doi: 10.3171/2017.11.FOCUS17621.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Pro00064110
Identifier Type: -
Identifier Source: org_study_id