What side effects are associated with this type of intervention?

Common side effects of non-invasive brain stimulation treatments for Major Depression, such as Transcranial Magnetic Stimulation (TMS) and repetitive Transcranial Magnetic Stimulation (rTMS), include mild and transient symptoms like headaches, scalp discomfort at the stimulation site, tingling, and lightheadedness. Serious adverse events are rare, but there is a theoretical risk of seizures, particularly in individuals with epilepsy. These treatments are generally well-tolerated, with no long-term safety concerns established.

What prior FDA approvals exist?

The FDA has approved several non-invasive brain stimulation techniques for the treatment of Major Depression. One notable example is Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain. TMS has been shown to be effective in patients who have not responded to traditional antidepressant medications. Another technique is Transcranial Direct Current Stimulation (tDCS), which uses a low electrical current to modulate brain activity. These treatments are similar to the Personalized Low-Intensity Transcranial Focused Ultrasound Stimulation being studied, as they all aim to modulate neural activity in specific brain regions to alleviate depressive symptoms.

What other types of research exist?

Promising, novel alternatives to Personalized Low-Intensity Transcranial Focused Ultrasound Stimulation for Major Depression include: 1) Transcranial Magnetic Stimulation (TMS), which has demonstrated efficacy in reducing depressive symptoms and is available in the United States and the United Kingdom. 2) Transcranial Direct Current Stimulation (tDCS), which has shown potential in reducing negative symptoms in clinical trials. Both methods are non-invasive and target specific brain regions to modulate neural activity.

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Brain Stimulation

Ultrasonic Brain Stimulation for Depression

Phase 1 & 2

Waitlist Available

Led By Brian J Mickey, MD, PhD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-65, any gender

Primary diagnosis of major depressive disorder or bipolar disorder

Must not have

Implanted device in the head or neck

History of serious brain injury or other neurologic disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day and 7 days after stimulation

Awards & highlights

Summary

This trial is testing a new non-invasive brain stimulation method using sound waves for people with depression. The treatment aims to improve mood by targeting specific brain areas. Researchers will find the best settings for the treatment and then test its effectiveness. Ultrasound-based brain stimulation is a novel, non-invasive therapeutic approach to precisely target regions of interest.

Who is the study for?

Adults aged 18-65 with a primary diagnosis of major depressive disorder or bipolar disorder, currently experiencing a moderate-to-severe depressive episode without psychotic features for at least 2 months. Participants must not change psychiatric treatments during the study and women must use effective contraception.

What is being tested?

The trial is testing the Diadem prototype, which uses personalized low-intensity focused ultrasound to stimulate the brain non-invasively. The effects will be monitored psychologically and physiologically, then assessed through MRI in a blinded sham-controlled cross-over design.

What are the potential side effects?

Potential side effects are not specified but may include discomfort from wearing the device, headache or dizziness post-stimulation. Since it's non-invasive and doesn't involve drugs, traditional medication side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have been diagnosed with major depressive disorder or bipolar disorder.

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I have been feeling very down or depressed for at least 2 months without losing touch with reality.

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I agree to follow the study rules and not change my mental health treatments during the study.

Exclusion Criteria

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

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I have an implanted device in my head or neck.

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I have had a serious brain injury or neurological disorder.

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I have not had brain stimulation treatments like ECT, TMS, or VNS in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day and 7 days after stimulation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day and 7 days after stimulation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day and 7 days after stimulation for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Sadness scale of PANAS-X

Change in depression severity measured with the HDRS-6

Target engagement: MRI quantification of brain activation

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active stimulationExperimental Treatment1 Intervention

Personalized low-intensity transcranial focused ultrasound stimulation of deep brain target (subgenual cingulate or alternative targets)

Group II: Sham stimulationPlacebo Group1 Intervention

Personalized low-intensity transcranial focused ultrasound stimulation of lateral ventricle

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

Non-invasive brain stimulation techniques, such as Transcranial Magnetic Stimulation (TMS) and Transcranial Direct Current Stimulation (tDCS), are used to treat Major Depression by modulating neural activity in specific brain regions involved in mood regulation. TMS uses magnetic fields to stimulate nerve cells in the prefrontal cortex, which can help alleviate depressive symptoms by enhancing neural connectivity and activity in this area. tDCS applies a low electrical current to the scalp to alter brain function, potentially improving mood and cognitive function. These treatments are significant for Major Depression patients as they offer alternative options to pharmacotherapy, especially for those who are resistant to medications. Personalized approaches, like the studied low-intensity transcranial focused ultrasound stimulation, aim to target specific brain regions more precisely, potentially increasing treatment efficacy and reducing side effects.

New targets for rTMS in depression: a review of convergent evidence.