Anxiety DisordersNCT06169631
The Effects of Noninvasive Neuromodulation on Mental Wellness, Behavior, and Electrophysiology
A study testing Gen0b in people with Anxiety Disorders, run by Sanmai Technologies PBC dba Sanmai at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Gen0b
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2023to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sanmai Technologies PBC
Sunnyvale, California, 94087
Christina Le, 619-765-4786 ext. 103, christina.l@sanm.ai
Jay Sanguinetti, PhD
About this study
Official title: The Effects of Noninvasive Brain Stimulation on Mental States, Behavior, and Electrophysiology
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.
- Conditions
- Anxiety Disorders
- Being tested
- Gen0b
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gen0bDevice
The ultrasound will be administered to the brain region of interest.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Device: Gen0b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Rating Inventory
Psychological questionnaire used by clinicians to rate the severity of a patient's anxiety
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start29 Apr 2023
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Each experiment arm will have its own group(s).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanmai Technologies PBC dba Sanmai
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay Sanguinetti, PhD, Principal investigator, Sanmai Technologies PBCTaylor Kuhn, PhD, Principal investigator, Sanmai Technologies PBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169631
- Sponsor's protocol ID
- Pro00064110
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 20103504Kubanek J. Neuromodulation with transcranial focused ultrasound. Neurosurg Focus. 2018 Feb;44(2):E14. doi: 10.3171/2017.11.FOCUS17621.
PubMed 29385924Fini 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 28430535Legon 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 29968768Tufail 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 20547127Sanguinetti 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 32184714Hameroff 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 22664271Smith 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 27865882Kuhn 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Noninvasive Brain Stimulation on Mental States, Behavior, and Electrophysiology
- ClinicalTrials.gov ID
- NCT06169631
- Acronym / sponsor ID
- Pro00064110
- Conditions
- Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sanmai Technologies PBC dba SanmaiIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Each experiment arm will have its own group(s).
| Arm | Type | Receives |
|---|---|---|
| Experiment 1 | Experimental | Device: Gen0bThe 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. |
| Experiment 2a | Experimental | Device: Gen0bCurrent 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 |
| Experiment 2b | Experimental | Device: Gen0bExperiment 2b will expand on Experiment 2a protocol with multiple visits. Each visit will consist of the same activities as Experiment 2a. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gen0bThe ultrasound will be administered to the brain region of interest. | Device | Experiment 1, Experiment 2a, Experiment 2b |
Primary outcome
Hamilton Anxiety Rating Inventory
Time frame: 1 month
Psychological questionnaire used by clinicians to rate the severity of a patient's anxiety
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Results publication: PubMed 20103504Tyler WJ. Noninvasive neuromodulation with ultrasound? A continuum mechanics hypothesis. Neuroscientist. 2011 Feb;17(1):25-36. doi: 10.1177/1073858409348066. Epub 2010 Jan 25.
- Results publication: PubMed 29385924Kubanek J. Neuromodulation with transcranial focused ultrasound. Neurosurg Focus. 2018 Feb;44(2):E14. doi: 10.3171/2017.11.FOCUS17621.
- Results publication: PubMed 28430535Fini 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.
- Results publication: PubMed 29968768Legon 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.
- Results publication: PubMed 20547127Tufail 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.
- Results publication: PubMed 32184714Sanguinetti 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.
- Results publication: PubMed 22664271Hameroff 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.
- Results publication: PubMed 27865882Smith 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.
- Results publication: PubMed 37091318Kuhn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Sanguinetti, PhD principal investigator
Sanmai Technologies PBC
Taylor Kuhn, PhD principal investigator
Sanmai Technologies PBC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gen0b in people with Anxiety Disorders, run by Sanmai Technologies PBC dba Sanmai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisannette A Ruiz (520-343-1070, lisannette.r@sanm.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Rating Inventory (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06169631, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.