What side effects are associated with this type of intervention?

Common treatments for anxiety disorders using neuromodulation techniques, such as Transcranial Magnetic Stimulation (TMS), can have side effects including mild headaches, scalp discomfort at the stimulation site, tingling, spasms, or twitching of facial muscles. More rarely, patients may experience dizziness or lightheadedness. Serious side effects are uncommon but can include seizures, particularly in individuals with a history of epilepsy. These side effects are generally mild and transient, making neuromodulation a relatively safe option for treating anxiety disorders.

What prior FDA approvals exist?

FDA-approved treatments for anxiety disorders include various pharmacological and neuromodulation approaches. Pharmacological treatments primarily involve selective serotonin reuptake inhibitors (SSRIs) like sertraline and fluoxetine, and serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine. Neuromodulation techniques, while less common, include transcranial magnetic stimulation (TMS), which has shown efficacy in treating anxiety and depression. Although transcranial focused ultrasound (TUS) is still under investigation, it is similar to TMS in its noninvasive modulation of neural activity. These treatments offer alternative options for patients who may not respond to traditional pharmacotherapy.

What other types of research exist?

Promising novel alternatives to Transcranial Focused Ultrasound for anxiety disorders include Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), and mindfulness-based interventions such as Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT). These therapies have shown efficacy in related conditions and may offer benefits for anxiety disorders.

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Procedure

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

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

Must not have

History of head injury with loss of consciousness for more than 5 min

History of epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether using sound waves on the brain can help reduce anxiety. It includes both healthy people and those with anxiety disorders to see if the treatment is effective. The study will compare the effects of different numbers of treatments.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a head injury where I was unconscious for over 5 minutes.

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I have a history of epilepsy.

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I have a brain tumor.

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I am taking medication that could affect my brain activity.

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I have difficulty making decisions or remembering things.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hamilton Anxiety Rating Inventory

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for anxiety disorders, such as Transcranial Magnetic Stimulation (TMS) and Transcranial Direct Current Stimulation (tDCS), work by modulating neural activity in specific brain regions like the prefrontal cortex. TMS uses magnetic fields to induce electric currents, while tDCS applies a constant, low electrical current. These methods aim to normalize dysregulated brain activity patterns associated with anxiety, potentially reducing symptoms. This is important for patients as it provides alternative treatment options when traditional medications are ineffective.