Focused Ultrasound for Depression, Anxiety, and OCD
(VANTUS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new head-worn device, the ATTN201, which uses focused ultrasound to address symptoms of depression, anxiety, and obsessive-compulsive disorder (OCD). The researchers aim to evaluate the safety and effectiveness of this treatment and determine the best application for different brain areas. It targets adults experiencing mild to moderate depression, anxiety, or OCD who have been on the same medication for at least four weeks.
As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment approach.
What prior data suggests that the ATTN201 device is safe for treating depression, anxiety, and OCD?
Previous studies have shown that ultrasound technology, like that used in the ATTN201 device, is safe and free of harmful side effects. Ultrasound employs sound waves instead of radiation, offering a safer alternative. Research indicates that ultrasound is generally well-tolerated and maintains an excellent safety record, even after over 20 years of use in medical imaging. When used correctly by trained professionals, it presents no known risks. This evidence suggests that the ATTN201 head-worn focused ultrasound device should be safe for human use.12345
Why are researchers excited about this trial?
Researchers are excited about the focused ultrasound treatment for conditions like depression, anxiety, and OCD because it offers a novel, non-invasive way to target specific brain areas. Unlike standard treatments that often involve medications with systemic effects, this method uses a head-worn device to deliver low-intensity focused ultrasound to precise brain regions, such as the basolateral amygdala and dorsal anterior cingulate cortex, among others. This approach allows for targeted modulation of brain activity, potentially offering faster relief and fewer side effects. Additionally, the flexibility of crossing over to different target areas during treatment sessions allows personalized adjustments, which could enhance effectiveness for individual patients.
What evidence suggests that this trial's treatments could be effective for depression, anxiety, or OCD?
This trial will evaluate the effectiveness of low-intensity focused ultrasound (LIFU) using the ATTN201 head-worn device. It targets specific brain areas to help manage symptoms of depression, anxiety, and obsessive-compulsive disorder (OCD). Participants may receive LIFU targeting the basolateral amygdala, dorsal anterior cingulate cortex, anterior limb of the internal capsule, centromedian nucleus of the thalamus, rostral zona incerta, subthalamic nucleus, or anterior nucleus of the thalamus. Studies have shown that LIFU can improve symptoms of these conditions, with some patients reporting a better quality of life and significant reductions in OCD symptoms. Research indicates that focused ultrasound is a promising non-invasive technique, meaning it doesn't require surgery. Early findings suggest it can be a safe and effective option for people dealing with these mental health conditions.678910
Are You a Good Fit for This Trial?
This trial is for adults with mild to moderate depression, anxiety, or obsessive-compulsive disorder. Participants should not have severe symptoms and must meet other health requirements set by the study team.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive between 3 and 10 ATTN201 stimulation sessions spaced approximately 7 days apart
Follow-up
A remote final treatment-period follow-up approximately 2 weeks after the last stimulation captures the 2-week measurement
Long-term Follow-up
A remote 3-month post-treatment check-in captures durability and any delayed adverse events
What Are the Treatments Tested in This Trial?
Interventions
- ATTN201 head-worn focused ultrasound
Trial Overview
The study tests repeated sessions of a head-worn device (ATTN201) that uses low-intensity focused ultrasound to stimulate different deep-brain areas. Each participant receives all types of stimulation in a double-blind, crossover design.
How Is the Trial Designed?
7
Treatment groups
Experimental Treatment
ATTN201 head-worn low-intensity focused ultrasound delivered to the subthalamic nucleus (STN). Sessions at which the constrained Bayesian optimization algorithm assigns this target; stimulation parameters (pulse repetition frequency, duty cycle, target pressure) vary within the ITRUSST-bounded search space. Participants may cross over to other target arms at subsequent sessions.
ATTN201 head-worn low-intensity focused ultrasound delivered to the rostral zona incerta (rZi). Sessions at which the constrained Bayesian optimization algorithm assigns this target; stimulation parameters (pulse repetition frequency, duty cycle, target pressure) vary within the ITRUSST-bounded search space. Participants may cross over to other target arms at subsequent sessions.
ATTN201 head-worn low-intensity focused ultrasound delivered to the dorsal anterior cingulate cortex (dACC). Sessions at which the constrained Bayesian optimization algorithm assigns this target; stimulation parameters (pulse repetition frequency, duty cycle, target pressure) vary within the ITRUSST-bounded search space. Participants may cross over to other target arms at subsequent sessions.
ATTN201 head-worn low-intensity focused ultrasound delivered to the centromedian nucleus of the thalamus (CMN). Sessions at which the constrained Bayesian optimization algorithm assigns this target; stimulation parameters (pulse repetition frequency, duty cycle, target pressure) vary within the ITRUSST-bounded search space. Participants may cross over to other target arms at subsequent sessions.
ATTN201 head-worn low-intensity focused ultrasound delivered to the basolateral amygdala (BLA). Sessions at which the constrained Bayesian optimization algorithm assigns this target; stimulation parameters (pulse repetition frequency, duty cycle, target pressure) vary within the ITRUSST-bounded search space. Participants may cross over to other target arms at subsequent sessions.
ATTN201 head-worn low-intensity focused ultrasound delivered to the anterior nucleus of the thalamus (ANT). Sessions at which the constrained Bayesian optimization algorithm assigns this target; stimulation parameters (pulse repetition frequency, duty cycle, target pressure) vary within the ITRUSST-bounded search space. Participants may cross over to other target arms at subsequent sessions.
ATTN201 head-worn low-intensity focused ultrasound delivered to the anterior limb of the internal capsule (ALIC). Sessions at which the constrained Bayesian optimization algorithm assigns this target; stimulation parameters (pulse repetition frequency, duty cycle, target pressure) vary within the ITRUSST-bounded search space. Participants may cross over to other target arms at subsequent sessions.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Attune Neurosciences Inc
Lead Sponsor
University of Pennsylvania
Collaborator
University of California, San Francisco
Collaborator
Citations
1.
clinicaltrials.gov
clinicaltrials.gov/study/NCT07851038?aggFilters=status%3Anot%2Cphase%3A%2CfunderType%3AindustryNCT07851038 | Focused Ultrasound for Behavioral Health
This is a double-blind, within-participant crossover, multi-site dose-finding study evaluating the safety, feasibility, and preliminary ...
Focused Ultrasound for Behavioral Health
Every session delivers active ATTN201 stimulation; there is no sham or placebo condition. Participants and the on-site study staff who deliver ...
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Of the twelve total patients treated at Sunnybrook, fifty percent reported an improvement in their quality of life. Moreover, researchers found ...
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focused ultrasound capsulotomy was safe and effective in patients with OCD one year after treatment.
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