Recruiting

Noninvasive Neuromodulation

Sponsor:

Sanmai Technologies PBC dba Sanmai

Code:

NCT06169631

Conditions

Anxiety Disorders

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Gen0b

Study Details

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.

Conditions

Anxiety Disorders

Study ID

NCT06169631

Start date

Apr 29, 2023

Status verified date

Dec, 2023

Completion date

Apr, 2024

Anticipated

Primary completion date

Mar, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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

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.

Interventions

Gen0b

The ultrasound will be administered to the brain region of interest.

Primary outcome measure

  • Hamilton Anxiety Rating Inventory [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Lisannette A Ruiz

520-343-1070lisannette.r@sanm.ai

Stephanie French

650-417-8675stephanie.f@sanm.ai

Locations

Sanmai Technologies PBC

Recruiting

Sunnyvale, California, United States, 94087

Contacts

Christina Le

619-765-4786christina.l@sanm.ai

Principal Investigator:

Jay Sanguinetti, PhD

More Information

Sponsor

Sanmai Technologies PBC dba Sanmai

Last update posted

Dec 13, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sanmai Technologies PBC dba Sanmai on 2023-12-13.