Focused Ultrasound for Anxiety Disorders

Overseen By Christopher T Sege, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Anticholinergics, Neuroleptics, Sedatives, Opiates

Disqualifiers: Substance use disorder, Psychotic disorder, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2 days

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether transcranial focused ultrasound (tFUS), a non-invasive brain stimulation technique, can help individuals with anxiety or related issues respond better to emotional situations. Participants will undergo tasks and brain imaging to measure their reactions before and after receiving either active or inactive tFUS. This research could lead to new methods for enhancing anxiety treatments. Ideal participants are those currently receiving treatment for anxiety or related conditions and can comfortably engage in study activities like interviews and brain imaging. Participants will receive compensation for their time in the study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve future anxiety treatments.

Do I need to stop my current medications to join the trial?

You may need to stop certain medications to join the trial. Specifically, you cannot participate if you are currently taking anticholinergic, neuroleptic, or sedative/hypnotic medications. However, you can continue taking SSRIs, cholinesterase inhibitors, or NMDA receptor antagonists if you have been on a stable dose for at least four weeks before joining.

What prior data suggests that transcranial focused ultrasound (tFUS) is safe for treating anxiety disorders?

Research has shown that transcranial focused ultrasound (tFUS) is generally safe and well-tolerated. Studies have found that side effects are very rare. However, high intensities might cause minor bleeding or cell damage. These risks remain minimal with the low-intensity tFUS used in most studies. This non-invasive technique does not involve surgery or cuts and temporarily alters brain activity without causing lasting harm. While more research is needed to fully understand its safety, current evidence suggests tFUS is quite safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial focused ultrasound (tFUS) for anxiety disorders because it offers a non-invasive, targeted approach that differs from traditional treatments like medication and psychotherapy. Unlike medications that can take weeks to work and often come with side effects, tFUS aims to modulate brain activity directly and rapidly, potentially providing faster relief. Additionally, its ability to focus ultrasound waves precisely on specific brain areas makes it a promising tool for improving symptoms without the systemic side effects common with oral medications. This innovative technique could revolutionize how anxiety disorders are treated by offering a safe and efficient alternative.

What evidence suggests that transcranial focused ultrasound is effective for anxiety disorders?

Research suggests that transcranial focused ultrasound (tFUS) could be a promising treatment for anxiety-related conditions. tFUS is a non-invasive method, meaning it doesn't involve surgery, and it can temporarily change brain activity. Some studies have shown that tFUS can improve mood and reduce symptoms in conditions like anxiety by targeting specific deep areas of the brain. In this trial, participants will receive both active and sham tFUS on separate days to evaluate its effects. Although researchers are still studying the safety and effectiveness of tFUS, early results are encouraging. tFUS might help manage anxiety symptoms by influencing emotional responses in the future. ^{1 2 4 5 6}

Who Is on the Research Team?

Christopher Sege, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals who have recently started treatment for anxiety or related issues. They should be able to attend three sessions at the Medical University of South Carolina and participate in tasks involving emotional responses, both with and without brain stimulation via tFUS.

Inclusion Criteria

I have been diagnosed with an anxiety disorder or PTSD.

Is able to read consent document and provide informed consent

English is a first or primary fluent language

Exclusion Criteria

Lifetime diagnosis of psychotic disorder or bipolar mania

Currently taking chronic opiate medications or substances

I do not have a seizure disorder that prevents brain stimulation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete interviews, surveys, and tasks with MRI to assess anxiety and related concerns

1 day

1 visit (in-person)

Treatment

Participants undergo tasks with active and sham tFUS stimulation on separate days, with physiological responses measured

2 days

2 visits (in-person)

Follow-up

Participants are monitored for changes in anxiety and physiological responses post-stimulation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Focused Ultrasound

Trial Overview

The study tests transcranial focused ultrasound (tFUS), a non-invasive brain stimulation method, to see if it can influence how people with anxiety respond to emotional situations. Participants will receive either active tFUS that temporarily alters brain activity or sham (inactive) tFUS.

How Is the Trial Designed?

Group I: Group Receiving Active Stimulation and Sham Stimulation on Separate Days (All Participants) Experimental Treatment 2 Interventions

All participants will receive active stimulation and non-active (sham) stimulation on different days. Before the stimulation sessions, all participants will complete experimental tasks during functional magnetic resonance imaging. On the next two study days, all participants will complete tasks before and after receiving active transcranial focused ultrasound (tFUS) on one day and sham (non-active) tFUS on another day. Stimulation (active or sham) is conducted briefly (\< 10 minutes) in between tasks, not during tasks.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

Microfocused Ultrasound with Visualization (MFU-V) has a well-established safety profile, showing only mild and transient side effects like tenderness and redness, with rare adverse events typically linked to improper technique.

When used correctly, MFU-V treatments are safe, with most side effects resolving quickly and without lasting effects, indicating its efficacy in cosmetic dermatology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the safety profile for microfocused ultrasound with visualization. Hitchcock, TM., Dobke, MK.[2022]

The second-generation MRgFUS system significantly improved treatment outcomes for uterine fibroids, achieving higher nonperfused volume ratios compared to the first-generation system, indicating better efficacy in ablation.

Since the introduction of the second-generation system, there have been no major adverse events or hospital admissions, highlighting enhanced patient safety during MRgFUS treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Clinical Performance Between Two Generations of Magnetic Resonance-guided Focused Ultrasound Systems in Treatments of Uterine Leiomyomas. Browne, JE., Gorny, KR., Hangiandreou, NJ., et al.[2021]

Magnetic Resonance-guided Focused Ultrasound (MRgFUS) shows promise as an effective treatment for refractory neuropathic pain, with studies involving 66 patients indicating variable degrees of pain improvement.

The safety profile of MRgFUS is favorable, with only mild and transient adverse events reported, and a major adverse event (intracerebral bleeding) occurring in just one case, suggesting it is a relatively safe option for patients with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance-guided Focused Ultrasound thalamotomy for refractory neuropathic pain: a systematic review and critical appraisal of current knowledge. Taranta, V., Saporito, G., Ornello, R., et al.[2023]

High-intensity focused ultrasound (HIFU) guided by MRI is a non-invasive method that allows for precise thermal ablation of target tissues while protecting surrounding organs, enhancing the safety of the procedure.

MRgFUS is clinically established for treating symptomatic uterine fibroids and shows promising results for various conditions, including palliative care for bone metastases and treatment of tumors in the prostate, breast, liver, and brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[MR-guided focused ultrasound. Current and future applications]. Trumm, CG., Napoli, A., Peller, M., et al.[2022]

MR-guided focused ultrasound (MRgFUS) shows promise in treating neuropsychiatric disorders like obsessive-compulsive disorder (OCD) and depression, with preliminary studies indicating improvements in symptoms, although more rigorous trials are needed.

Low-intensity MRgFUS may help open the blood-brain barrier and modulate brain activity, but current evidence is limited, necessitating further comparative studies to evaluate its effectiveness against other treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incisionless MR-guided focused ultrasound: technical considerations and current therapeutic approaches in psychiatric disorders. Kinfe, T., Stadlbauer, A., Winder, K., et al.[2021]

Focused ultrasound surgery (FUS) is a noninvasive treatment that effectively destroys targeted tissues while protecting surrounding areas, making it a safe option for patients.

When combined with magnetic resonance guidance (MRgFUS), this technique allows for real-time monitoring and personalized treatment, showing promising results in conditions like uterine fibroids and potential applications in prostate and liver tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ExAblate magnetic resonance-guided focused ultrasound system in multiple body applications. Dick, EA., Gedroyc, WM.[2010]

A systematic review of 33 studies on low-intensity transcranial focused ultrasound stimulation (TFUS) indicates that adverse effects are very rare, with most studies showing no significant negative outcomes even when safety limits were exceeded.

However, at high stimulation intensities, TFUS can potentially cause serious issues like hemorrhage, cell death, and unintended blood-brain barrier opening, highlighting the need for further research to establish clear safety guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial focused ultrasound stimulation: A systematic review of the state of knowledge from both human and animal studies. Pasquinelli, C., Hanson, LG., Siebner, HR., et al.[2020]

Magnetic resonance-guided focused ultrasound (MRgFUS) is a safe and effective incisionless treatment for centrally located brain lesions in adolescents and young adults, with no complications reported in a study of 5 patients aged 15-22.

The procedure successfully achieved thermoablation in 4 out of 5 cases, leading to improvements in symptoms such as seizure control, demonstrating its potential therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with magnetic resonance-guided focused ultrasound stereotactic surgery for central brain lesions in young adults. Tierney, TS., Alavian, KN., Altman, N., et al.[2022]

The study evaluated different MR coils for use in MRI-guided Focused Ultrasound Surgery (MRgFUS) for liver tumors, finding that single-loop four-channel Duoflex and Gem coils provided reliable thermal readings and signal quality during dynamic tracking.

Body array coils were found to be unsuitable for liver MRgFUS due to significant signal loss, suggesting that specialized coil designs are necessary for effective treatment in dynamic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR-guided focused ultrasound application for moving target tumor ablation in abdominal area: coil selection. Mihcin, S., Gagliardo, C., Toia, P., et al.[2021]

Magnetic-resonance-guided focused ultrasound (MRgFUS) is a noninvasive and effective treatment for symptomatic uterine fibroids, preserving the uterus while alleviating symptoms.

The review highlights the importance of understanding MRgFUS technology, patient selection, and outcomes, as well as its potential impact on fertility, which is crucial for interventional radiologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updates on MR-Guided Focused Ultrasound for Symptomatic Uterine Fibroids. Sridhar, D., Kohi, MP.[2020]

Focused ultrasound is a noninvasive brain stimulation technique that offers precise targeting, combining benefits from both repetitive transcranial magnetic stimulation and deep brain stimulation.

High-intensity focused ultrasound is already being used in incisionless surgeries, such as capsulotomies for treating obsessive-compulsive disorder, showcasing its therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound as a Neurotherapeutic: A Circuit- and System-Based Interrogation. Spivak, NM., Tyler, WJ., Bari, AA., et al.[2023]

Transcranial focused ultrasound (tFUS) can selectively target and modulate deep brain structures, such as the amygdala and entorhinal cortex, in healthy adults, leading to significant changes in brain perfusion and activity.

The study demonstrated that tFUS does not activate the auditory cortex, indicating that its effects are due to direct neuromodulation rather than an acoustic response, suggesting potential therapeutic applications for neurological and psychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial focused ultrasound selectively increases perfusion and modulates functional connectivity of deep brain regions in humans. Kuhn, T., Spivak, NM., Dang, BH., et al.[2023]

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