300 Participants NeededMy employer runs this trial

Focused Ultrasound for Depression, Anxiety, and OCD

(VANTUS Trial)

Recruiting at 1 trial location
KM
Overseen ByKeith Murphy, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

Sign the informed consent form, in accordance with local requirements, after the scope and nature of the investigation have been explained to the participant, and before any screening assessments
Be able to speak, read, and understand English
I am between 22 and 80 years old.
See 11 more

Exclusion Criteria

Columbia Suicide Severity Rating Scale (C-SSRS) score ≥ 3 (ideation with intent, with or without plan) at screening
Has an unstable or severe medical or psychiatric condition that, in the investigator's judgment, would pose a safety risk to the participant or prevent completion of study procedures; stable comorbid conditions within protocol-specified score windows are permitted
Any suicide attempt within the past 12 months
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants receive between 3 and 10 ATTN201 stimulation sessions spaced approximately 7 days apart

3-10 weeks
3-10 visits (in-person)

Follow-up

A remote final treatment-period follow-up approximately 2 weeks after the last stimulation captures the 2-week measurement

2 weeks
1 visit (remote)

Long-term Follow-up

A remote 3-month post-treatment check-in captures durability and any delayed adverse events

3 months
1 visit (remote)

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

Group I: Subthalamic nucleus (STN)Experimental Treatment1 Intervention
Group II: Rostral zona incerta (rZi)Experimental Treatment1 Intervention
Group III: Dorsal anterior cingulate cortex (dACC)Experimental Treatment1 Intervention
Group IV: Centromedian nucleus of thalamus (CMN)Experimental Treatment1 Intervention
Group V: Basolateral amygdala (BLA)Experimental Treatment1 Intervention
Group VI: Anterior nucleus of thalamus (ANT)Experimental Treatment1 Intervention
Group VII: Anterior limb of internal capsule (ALIC)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Attune Neurosciences Inc

Lead Sponsor

Trials
1
Recruited
30+

University of Pennsylvania

Collaborator

Trials
2,118
Recruited
45,270,000+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

Citations

NCT07851038 | 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 ...

Focused Ultrasound for Psychiatric Disorders: Clinical Trial ...

Of the twelve total patients treated at Sunnybrook, fifty percent reported an improvement in their quality of life. Moreover, researchers found ...

Transcranial focused ultrasound targeting the default mode ...

A novel neuromodulation technique, non-invasive Transcranial Focused Ultrasound Stimulation (tFUS), holds promise in the treatment of depression ( 18 , 19 ).

Ultrasound

Diagnostic ultrasound is a safe procedure that uses low-power sound waves. There are no known risks. such as the lungs or head.

Ultrasound: Procedure Details & Results

Yes, research has largely shown ultrasound technology to be safe with no harmful side effects. Ultrasound doesn't use radiation, unlike some ...

Ultrasound: MedlinePlus Medical Test

Ultrasound has not been linked to any health harms. It's generally considered safe when trained sonographers use it correctly. Ultrasound doesn ...

Ultrasound

Ultrasonic inspection eliminates the use of ionizing radiation, with safety and cost benefits. Ultrasound can also provide additional information such as the ...

Medical ultrasound imaging

The paper gives an introduction to current medical ultrasound imaging systems. The basics of anatomic and blood flow imaging are described.