Focused Ultrasound for Anxiety Disorders
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical University of South Carolina
No Placebo Group
Trial Summary
What is the purpose of this trial?This is a study to find out if a cutting-edge technology called transcranial focused ultrasound (tFUS) can be used to treat how people with anxiety or related concerns cope with emotional situations. tFUS is a brain stimulation technology that causes temporary changes in the activity of deep brain areas without a need for any surgery or other permanent or invasive procedures.
This study is recruiting participants who recently started treatment for anxiety or a related concern to come in for 3 visits at the Medical University of South Carolina. At the first visit, participants will do interviews and surveys asking about anxiety and related concerns, and they do tasks where they respond to emotional pictures while brain activity is measured using magnetic resonance imaging (MRI). At the next two visits, participants again do a task where they see and react to emotional images, and this time the task is done once before and again once after receiving tFUS that either actively causes temporary changes (lasting for about an hour) in a targeted brain area or is not active (no changes elicited). At each tFUS visit, responses are measured with sensors worn on the hand, arms, face, and head (these visits do not involve MRI).
Each visit in this study is expected to last between 2 - 3 hours. This study is not a treatment study, but it could help improve treatment in the future. Participants in this study are paid for their time.
How does focused ultrasound treatment for anxiety disorders differ from other treatments?
Focused ultrasound is unique because it is a non-invasive treatment that uses sound waves to target specific areas of the brain without surgery. Unlike traditional treatments, it can precisely ablate (destroy) or modulate brain tissue, offering a new approach for treating anxiety disorders.
246710Is focused ultrasound generally safe for humans?
The safety of focused ultrasound, including techniques like MRgFUS and tFUS, has been studied for various conditions. For example, microfocused ultrasound has shown only mild and temporary side effects like tenderness and redness, with rare serious issues often linked to incorrect use. While more research is needed, especially for brain applications, these techniques are generally considered safe when used properly.
345911What data supports the effectiveness of the treatment Transcranial Focused Ultrasound for anxiety disorders?
Research shows that Magnetic Resonance-guided Focused Ultrasound (MRgFUS) has been effective in treating various conditions like uterine fibroids, movement disorders, and neuropathic pain by precisely targeting and treating specific areas in the body. This suggests potential for its use in treating anxiety disorders, as it can target brain areas involved in these conditions.
147812Do 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.
Eligibility Criteria
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.
I am between 18 and 65 years old.
Exclusion Criteria
I do not have a seizure disorder that prevents brain stimulation.
I have had a traumatic brain injury with loss of consciousness in my life.
I am currently taking naltrexone.
I have a condition that makes it hard for me to stay still for long periods.
I have a history of seizures or epilepsy.
I have conditions or take treatments that increase my risk of seizures.
I have a neurodegenerative disorder like Alzheimer's, Parkinson's, or Frontotemporal Dementia.
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Group Receiving Active Stimulation and Sham Stimulation on Separate Days (All Participants)Experimental Treatment2 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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Medical University of South CarolinaCharleston, SC
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
References
ExAblate magnetic resonance-guided focused ultrasound system in multiple body applications. [2010]Focused ultrasound surgery (FUS) is a completely noninvasive method of thermally destroying a target tissue while sparing adjacent tissues and organs. Treatment is relatively painless and can be carried out under conscious sedation on an out-patient basis. The combination of magnetic resonance guidance with FUS (MRgFUS) provides the ability to plan and monitor treatments in near real-time, further increasing the safety profile of MRgFUS. This technology provides a very personalized treatment, adjusted to the individual patient anatomy, pathology and treatment response, hence it meets the needs of patients, as well as of physicians. MRgFUS has been used extensively in the successful treatment of uterine fibroids, and has been shown to be an effective treatment in the breast and in bone metastases in smaller scale studies. It shows great potential in the treatment of prostate and liver tumors, as well as in the brain and facet joints.
[MR-guided focused ultrasound. Current and future applications]. [2022]High-intensity focused ultrasound (synonyms FUS and HIFU) under magnetic resonance imaging (MRI) guidance (synonyms MRgFUS and MR-HIFU) is a completely non-invasive technology for accurate thermal ablation of a target tissue while neighboring tissues and organs are preserved.
Review of the safety profile for microfocused ultrasound with visualization. [2022]The Safety of Microfocused Ultrasound with Visualization (MFU-V) has been well established in both controlled clinical studies and in clinical use, showing only mild and transient anticipated side effects and only rare unanticipated adverse events (AEs). This publication discusses the safety profile of MFU-V based on data from a variety of sources. Reports of side effects and AEs were obtained from published peer-reviewed medical literature, clinical studies, in-market use reports (AEs reported to the manufacturer), and retrospective chart reviews of patient treatments. Events that were typical included tenderness, redness, and slight edema. Rare events included bruising, welting, and nerve-related effects (paresthesia and paresis). Rare incidence of surface thermal effects was seen in some cases where improper technique was used. In all cases where the device was uses properly, the safety events reported tended to be transient, mild in nature, and resolved without sequelae. In general, unexpected and rare AEs could be attributed to incorrect treatment technique or classified as unrelated to MFU-V treatment. Side effects that do occur are generally mild and transient in nature. MFU-V consistently allows for safe treatment when correct treatment technique is used.
Updates on MR-Guided Focused Ultrasound for Symptomatic Uterine Fibroids. [2020]Magnetic-resonance-guided focused ultrasound (MRgFUS), also called high-intensity focused ultrasound (HIFU) is an effective, noninvasive uterine-preserving treatment for symptomatic uterine fibroids. As the use of this therapeutic modality is not yet widespread, it may remain unfamiliar to many interventional radiologists. The purpose of this review is to discuss MRgFUS, including technology, patient selection, technique, outcomes, complications, and recent data on fertility and comparative effectiveness.
Safety of transcranial focused ultrasound stimulation: A systematic review of the state of knowledge from both human and animal studies. [2020]Low-intensity transcranial focused ultrasound stimulation (TFUS) holds great promise as a highly focal technique for transcranial stimulation even for deep brain areas. Yet, knowledge about the safety of this novel technique is still limited.
MR-guided focused ultrasound application for moving target tumor ablation in abdominal area: coil selection. [2021]Magnetic Resonance Imaging (MRI)-guided Focused Ultrasound Surgery (MRgFUS) is a non-invasive thermal ablation method utilizing high-intensity focused ultrasound (HI-FU) energy for tissue ablation under MRI with real-time thermal mapping. Ablating to a dynamic target as in the liver is very challenging, requiring approval. A novel quality-assured liver tumor ablation system has been proposed for clinics. The paper reports the evaluation of conventional and new MR-receiving coils.
Incisionless MR-guided focused ultrasound: technical considerations and current therapeutic approaches in psychiatric disorders. [2021]MR-guided focused ultrasound operating at higher intensities have been reported to effectively and precisely ablate deeper brain structures like the basal ganglia or the thalamic nuclei for the treatment of refractory movement disorders, neuropathic pain and most recently neuropsychiatric disorders, while low-intensity focused ultrasound represents an approach promoting mechanical blood-brain-barrier opening and neuromodulation. This narrative review summarizes the technical development and the therapeutic potential of incisionless MRgFUS in order to treat neuropsychiatric disorders.
Comparison of Clinical Performance Between Two Generations of Magnetic Resonance-guided Focused Ultrasound Systems in Treatments of Uterine Leiomyomas. [2021]The aim of this study was to evaluate the impact of technology improvements on the outcomes of magnetic resonance-guided focused ultrasound (MRgFUS) treatments of symptomatic uterine leiomyomas (uterine fibroids). The study compared ablation volumes and incidence of adverse events in patient groups treated with two generations of MRgFUS systems from a single vendor.
Initial experience with magnetic resonance-guided focused ultrasound stereotactic surgery for central brain lesions in young adults. [2022]Magnetic resonance-guided focused ultrasound (MRgFUS) is an incisionless procedure capable of thermoablation through the focus of multiple acoustic beams. Although MRgFUS is currently approved for the treatment of tremor in adults, its safety and feasibility profile for intracranial lesions in the pediatric and young adult population remains unknown.
Ultrasound as a Neurotherapeutic: A Circuit- and System-Based Interrogation. [2023]Focused ultrasound is a novel brain stimulation modality that combines the noninvasiveness of repetitive transcranial magnetic stimulation and the precision of deep brain stimulation. In this review, the authors examine low-intensity focused ultrasound for brain mapping and neuromodulation. They also discuss high-intensity focused ultrasound, which is used for incisionless surgeries, such as capsulotomies for obsessive-compulsive disorder. Future potential applications of focused ultrasound are also presented.
Transcranial focused ultrasound selectively increases perfusion and modulates functional connectivity of deep brain regions in humans. [2023]Low intensity, transcranial focused ultrasound (tFUS) is a re-emerging brain stimulation technique with the unique capability of reaching deep brain structures non-invasively.
Magnetic Resonance-guided Focused Ultrasound thalamotomy for refractory neuropathic pain: a systematic review and critical appraisal of current knowledge. [2023]Magnetic Resonance-guided Focused Ultrasound (MRgFUS) is an innovative therapeutical approach for medically refractory tremor. It is currently under investigation for other neurological diseases including refractory neuropathic pain (NP).