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Experiment 1 for Anxiety Disorders

N/A
Recruiting
Led By Jay Sanguinetti, PhD
Research Sponsored by Sanmai Technologies PBC dba Sanmai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants will be included for a past diagnosis of anxiety within the past year
18-65 years of age, as verified via photo identification with date of birth
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights

Study Summary

This trial tests if low-intensity ultrasound can help reduce symptoms of anxiety, using physical, mental, and cognitive tests.

Who is the study for?
This trial is for adults aged 18-65 who speak English and have been diagnosed with an anxiety disorder in the past year. It's not suitable for those who smoke or use nicotine, have had a significant head injury, uncorrected hearing/vision issues, certain mental illnesses, epilepsy, brain tumors, take drugs affecting brain activity or are pregnant.Check my eligibility
What is being tested?
The study is examining the impact of a noninvasive technique called transcranial focused ultrasound (TUS) on various aspects related to anxiety disorders. This includes changes in brain activity patterns, behavior shifts and cognitive functions associated with anxiety.See study design
What are the potential side effects?
While TUS is generally considered safe and noninvasive, potential side effects may include discomfort at the site of application or mild headaches. Since it involves sound waves affecting the brain, there might be unforeseen reactions depending on individual sensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was diagnosed with anxiety in the last year.
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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hamilton Anxiety Rating Inventory

Trial Design

3Treatment groups
Experimental Treatment
Group I: Experiment 2bExperimental Treatment1 Intervention
Experiment 2b will expand on Experiment 2a protocol with multiple visits. Each visit will consist of the same activities as Experiment 2a.
Group II: Experiment 2aExperimental Treatment1 Intervention
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
Group III: Experiment 1Experimental Treatment1 Intervention
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.

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Who is running the clinical trial?

Sanmai Technologies PBC dba SanmaiLead Sponsor
Jay Sanguinetti, PhDPrincipal InvestigatorSanmai Technologies PBC
Taylor Kuhn, PhDPrincipal InvestigatorSanmai Technologies PBC
1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment have an age-related limitation for participants?

"This clinical trial is available to all individuals aged 18 and above who are below the age of 65."

Answered by AI

What is the participant count for this experiment?

"Affirmative. Based on information posted to clinicaltrials.gov, the study is currently enrolling participants and has a target of 100 patients from one medical centre. The trial was first announced on April 29th 2023 and last modified on December 12th 2023."

Answered by AI

Are there any openings left for participants in this research project?

"Clinicaltrials.gov reveals that this investigation is actively seeking participants, with its initial post on April 29th 2023 and a subsequent update made December 12th of the same year."

Answered by AI

What criteria must one satisfy to be eligible for participation in this research?

"To be eligible for this trial, the applicant must suffer from an anxiety disorder and fall within the specified demographic of 18-65 years old. The total quota for participants is 100 people."

Answered by AI

Who else is applying?

What site did they apply to?
Sanmai Technologies PBC
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Anxiety has been a life-long struggle and it holds me back from so much in life. I'm willing to try new things.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
The Effects of Noninvasive Neuromodulation on Mental Wellness, Behavior, and Electrophysiology
2023. "The Effects of Noninvasive Neuromodulation on Mental Wellness, Behavior, and Electrophysiology". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06169631.
~52 spots leftby Apr 2025
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