Focused Ultrasound for Anxiety
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment option for individuals with generalized anxiety disorder (GAD) who haven't found relief with standard medications. The research focuses on the Aortix Endovascular Device, which delivers low-intensity ultrasound waves to the amygdala, a brain area linked to anxiety. Participants will undergo this treatment over four sessions to determine its effectiveness in reducing anxiety. Individuals who have had GAD for more than a year and have tried at least two medications without success might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could provide relief where standard medications have not.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot start any new anxiety treatments when you join the study. You can continue medications for generalized anxiety disorder that you are already taking.
What prior data suggests that this device is safe for treating anxiety?
Research has shown that Low-Intensity Focused Ultrasound Pulsation (LIFUP) is generally manageable for patients. One study reported no serious side effects, with participants showing noticeable improvements in mood and anxiety. Another study found no harmful reactions during treatment. These findings suggest that LIFUP might safely target brain areas related to anxiety, such as the amygdala. While the safety results are encouraging, it is important to remember that LIFUP is still under study to confirm these findings.12345
Why are researchers excited about this trial?
Researchers are excited about the Low-Intensity Focused Ultrasound Pulsation (LIFUP) for Generalized Anxiety Disorder because it offers a new, non-invasive approach to treatment. Unlike traditional options like medication and therapy, LIFUP targets the amygdala directly, a brain region crucial in anxiety, using ultrasound waves. This method could provide faster relief with fewer side effects, as it avoids systemic drug interactions and the long wait times often needed for medications to take effect. Additionally, the treatment sessions are brief and do not produce any sound, enhancing comfort and compliance for patients.
What evidence suggests that this device is effective for generalized anxiety disorder?
This trial will compare the effects of Low Intensity Focused Ultrasound (LIFUP) with a sham treatment. Research has shown that LIFUP might help reduce anxiety symptoms. One study found that participants felt better and less anxious after the treatment. Another study also showed improvements from before to after the treatment. Participants handled the procedure easily, with no serious side effects reported. LIFUP targets the amygdala, a part of the brain linked to anxiety, which might explain its effectiveness. Early results suggest that LIFUP could be a good option for those who haven't found relief with standard anxiety treatments.12345
Who Is on the Research Team?
Margaret G Distler, MD,PhD
Principal Investigator
University of California, Los Angeles
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive eight treatments over four sessions of focused ultrasound stimulation to the amygdala
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Device
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Device: Low Intensity Focused Ultrasound Device Low Intensity Focused Ultrasound Pulsation (LIFUP) of amygdala (a key area for anxiety) will be performed during two sessions. The proposed experiment will involve behavioral (e.g. HAM-A) and paramedical (i.e., MRI/fMRI) measurements just before and after each of the two LIFUP sessions (i.e., 5 non-consecutive minutes of stimulation in each session). The device does not produce a sound when operating and as such, the active group will well blinded.
Sham Treatment consists of placing the device but not turning it on. The device does not produce a sound when operating and as such, the sham group will well blinded.
Device is already approved in United States for the following indications:
- None - Investigational use only
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
Massachusetts General Hospital
Collaborator
Medical University of South Carolina
Collaborator
Citations
a double-blind sham-controlled target engagement study and ...
rtFUS was well-tolerated with no serious adverse events. There were significant reductions on the primary outcome (Mood and Anxiety Symptom ...
Low-intensity transcranial focused ultrasound amygdala ...
Most secondary outcomes demonstrated pre- to post-treatment improvements at p < 0.05 uncorrected (Supplementary Fig. 5 and Table 2), including ...
3.
fusfoundation.org
fusfoundation.org/posts/clinical-trial-results-focused-ultrasound-neuromodulation-improves-mood-anxiety-and-trauma-related-disorders/Clinical Trial Results
The primary outcome measures were rate of treatment completion and treatment response as measured by the Mood and Anxiety Symptom Questionnaire ...
A pilot study of low-intensity focused ultrasound for ...
Low-intensity focused ultrasound shows promise as a clinical intervention for anxiety. · Safety and tolerability of LIFUP protocol confirmed among 25 ...
Low Intensity Focused Ultrasound for Learning and ...
The goal of this clinical trial is to investigate the impact of low intensity focused ultrasound pulsation (LIFUP) to two different brain regions, ...
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