What side effects are associated with this type of intervention?

Common treatments similar to Transcranial Focused Ultrasound (tFUS) include Transcranial Magnetic Stimulation (TMS) and Transcranial Direct-Current Stimulation (tDCS). Known side effects of TMS can include headaches, scalp discomfort at the stimulation site, and, rarely, seizures. tDCS side effects are generally mild and may include skin irritation, tingling sensations, and headaches. Both treatments are considered safe for short-term use, but long-term safety data are limited.

What prior FDA approvals exist?

The FDA has approved various neuromodulation therapies, though not specifically for healthy subjects. Treatments like Transcranial Magnetic Stimulation (TMS) and Vagus Nerve Stimulation (VNS) have been approved for conditions such as depression and epilepsy. These therapies, similar to Transcranial Focused Ultrasound (tFUS), aim to modulate brain activity. TMS, for instance, targets the prefrontal cortex to treat depression, while VNS involves stimulating the vagus nerve to manage epilepsy. Both methods reflect the broader category of targeted deep brain neuromodulation.

What other types of research exist?

Promising alternatives to Transcranial Focused Ultrasound (tFUS) for targeted deep brain neuromodulation include Repetitive Transcranial Magnetic Stimulation (rTMS) and Transcranial Direct Current Stimulation (tDCS). rTMS has shown modest effectiveness in various conditions and is considered safe for short-term treatment. tDCS is another non-invasive technique that has been investigated for its potential in treating inattention in adults with ADHD.

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Focused Ultrasound

Transcranial Focused Ultrasound Safety in Healthy Subjects

N/A

Recruiting

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Summary

This trial tests a new wearable device called Attune ATTN201 that uses sound waves to stimulate specific parts of the brain. It focuses on people whose brain activity is being studied. The device aims to change brain activity by sending sound waves to precise areas without affecting other parts of the brain.

Who is the study for?

This trial is for healthy adults aged 22-55 who speak English, can consent, and have no history of mental or physical illness. Women must not be pregnant and participants should not have metal implants. All must commit to the study schedule.

What is being tested?

The study tests a device called Attune ATTN201 using Transcranial Focused Ultrasound (tFUS) on the Central Medial Thalamus in the brain to see how it affects sleep induction and brain activity without harming surrounding tissue.

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort from wearing the device, headache or dizziness post-treatment, changes in mood or cognitive function due to stimulation of brain areas.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Feasibility of tFUS in healthy adults looking at retention and with a tFUS credibility questionnaire

Incidence of Adverse Events and Side Effects as assessed by Review of Systems Screener

Secondary study objectives

Dose-response effects of tFUS on electroencephalographic (EEG) recordings

Effects of tFUS parameter alterations between part one and part two on electroencephalographic (EEG) recordings and behavior

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: Focused Ultrasound Dose #8Experimental Treatment1 Intervention

Focused Ultrasound will be administered using high frequency stimulation as condition 4. Stimulation will last 1-10 minutes.

Group II: Focused Ultrasound Dose #7Experimental Treatment1 Intervention

Focused Ultrasound will be administered using medium frequency stimulation as condition 4. Stimulation will last 1-10 minutes.

Group III: Focused Ultrasound Dose #6Experimental Treatment1 Intervention

Focused Ultrasound will be administered using low frequency stimulation as condition 4. Stimulation will last 1-10 minutes.

Group IV: Focused Ultrasound Dose #3Experimental Treatment1 Intervention

Focused Ultrasound will be administered using low frequency stimulation as condition 4. Stimulation will last 1-10 minutes.

Group V: Focused Ultrasound Dose #2Experimental Treatment1 Intervention

Focused Ultrasound will be administered using medium frequency stimulation as condition 2. Stimulation will last 1-10 minutes.

Group VI: Focused Ultrasound Dose #1Experimental Treatment1 Intervention

Focused Ultrasound will be administered using high frequency stimulation as condition 1. Stimulation will last 1-10 minutes.

Group VII: Focused Ultrasound Dose #5Placebo Group1 Intervention

Focused Ultrasound will be administered using the sham condition.

Group VIII: Focused Ultrasound Dose #4Placebo Group1 Intervention

Focused Ultrasound will be administered using the sham condition.

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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

Neuromodulation techniques such as Transcranial Magnetic Stimulation (TMS) and Vagus Nerve Stimulation (VNS) work by altering neural activity through targeted electrical or magnetic stimulation. TMS uses magnetic fields to induce electric currents in specific brain regions, which can modulate neuronal activity and connectivity. VNS involves stimulating the vagus nerve to influence brain regions involved in mood and pain regulation. Transcranial Focused Ultrasound (tFUS) is a newer method that uses ultrasound waves to target deep brain structures without affecting surrounding tissues. These treatments are significant for healthy subjects as they offer potential noninvasive options for modulating brain function, which could be beneficial for research into brain activity, cognitive enhancement, and potentially preventing or mitigating neurological disorders.