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

December 12, 2023 updated by: Sanmai Technologies PBC dba Sanmai

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Sunnyvale, California, United States, 94087
        • Recruiting
        • Sanmai Technologies PBC
        • Contact:
        • Principal Investigator:
          • Jay Sanguinetti, PhD
        • Sub-Investigator:
          • Sharena Rice, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Gen0b
The ultrasound will be administered to the brain region of interest.
Experimental: 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
Device: Gen0b
The ultrasound will be administered to the brain region of interest.
Experimental: Experiment 2b
Experiment 2b will expand on Experiment 2a protocol with multiple visits. Each visit will consist of the same activities as Experiment 2a.
Device: Gen0b
The ultrasound will be administered to the brain region of interest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Anxiety Rating Inventory
Time Frame: 1 month
Psychological questionnaire used by clinicians to rate the severity of a patient's anxiety
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanmai Technologies PBC dba Sanmai

Investigators

  • Principal Investigator: Jay Sanguinetti, PhD, Sanmai Technologies PBC
  • Principal Investigator: Taylor Kuhn, PhD, Sanmai Technologies PBC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Actual)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00064110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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