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Focused Ultrasound for Behavioral Health

Key facts

Who runs it
Attune Neurosciences Inc
Where
San Francisco, United StatesSee the 2 sites
Trial code
Status
Recruiting
People taking part
300 people, planned
Started
19 Oct 2026
Expected to end
17 May 2028
Type of study
Interventional, 7 groups
Treatments tested
  • ATTN201 head-worn focused ultrasound
Record updated
27 October 2026

Who can take part

Age
22 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 28 criteriaShow less

Who can take part

  • Be between 22 and 80 years of age (inclusive) on the day of signing informed consent
  • Have at least one of the following at screening: PHQ-9 total score 5-16 (depression), GAD-7 total score 5-14 (anxiety), or OCI-R total score 14-27 (obsessive-compulsive disorder)
  • If currently taking psychiatric medication, have been on the same stable dose(s) for at least 4 weeks prior to screening and be willing to maintain the regimen throughout the treatment period
  • Be able and willing to undergo a multi-sequence cranial MRI
  • Be willing to use the ATTN201 device during stimulation visits and to attempt use of monitoring devices (optional ambulatory EEG system, smart watch) during the pre- and post-stimulation monitoring blocks; use of the optional ambulatory EEG system does not affect eligibility
  • 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
  • Be able to use a smartphone and the Attune platform
  • Possess the ability to respond verbally to questions, follow instructions, and complete study assessments
  • Be able to adhere to the treatment protocol and visit schedules through the 3-month post-treatment follow-up
  • Be judged by the investigator as likely to comply with study procedures and willing to participate in the entirety of the study
  • Be determined by the investigator to be medically stable at baseline as assessed by medical history and non-significant clinical results of a vital signs examination
  • Male participants must ensure a condom is used for all sexual intercourse and follow acceptable methods of contraception for their female partner for the entire duration of the study and for 90 days after the final study visit. Male participants should not father a child or donate sperm during this same period
  • Female participants who are sexually active agree to use two methods of contraception for the duration of the study and for 30 days after the final study visit, or not be of childbearing potential as indicated by natural menopause (≥12 consecutive months of spontaneous amenorrhea), hysterectomy, bilateral tubal ligation, bilateral oophorectomy (with or without hysterectomy) more than 6 weeks prior to screening, or a vasectomized partner with documented absence of sperm

Who cannot take part

  • Any change in psychiatric medication (start, stop, or dose change) within 4 weeks prior to screening
  • Has any contraindications for completing a brain MRI scan (e.g., pacemaker, ferromagnetic implants)
  • Has received an investigational drug or device in another clinical study within 30 days before 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 (e.g., treated depression, anxiety, OCD, insomnia) within the protocol-specified score windows are permitted
  • Has an active, unstable substance use disorder including alcohol use disorder in the past 6 months (except for caffeine and nicotine). Participants on stable medication-assisted treatment (e.g., buprenorphine, methadone, naltrexone) for at least 6 months are eligible
  • Has a history of moderate-to-severe traumatic brain injury, or mild traumatic brain injury within the past 12 months
  • Has a history of seizure disorder or epilepsy, or any structural CNS lesion known to lower seizure threshold
  • Has a known allergy or sensitivity to ultrasound gel, silicone, or adhesive materials used in monitoring devices
  • Has an active skin condition at sensor placement sites that would prevent device wear
  • Columbia Suicide Severity Rating Scale (C-SSRS) score ≥ 3 (ideation with intent, with or without plan) at screening
  • Any suicide attempt within the past 12 months
  • Body mass index (BMI) greater than 40 kg/m²
  • Is pregnant, is attempting to become pregnant, or is nursing
  • Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is an investigational site or Sponsor staff member directly involved with this trial

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 22 and 80 years old?

Where in United States

  • Attune Neurosciences, Inc.San Francisco, United StatesContact: Keith Murphy, PhDNot yet recruiting
  • Attune, San Francisco Clinical Research CenterSan Francisco, United StatesContact: Keith Murphy, PhDTaking people

About the trial

What the trial wants to find out

This is a double-blind, within-participant crossover, multi-site dose-finding study evaluating the safety, feasibility, and preliminary efficacy of repeated low-intensity focused ultrasound (LIFU) stimulation using the ATTN201 device across seven candidate deep-brain targets in adults with subsyndromal-to-moderate depression, anxiety, or obsessive-compulsive disorder. Every session delivers active ATTN201 stimulation; there is no sham or placebo condition. Participants and the on-site study staff who deliver stimulation and administer the clinical scales are blinded to the brain target and to the stimulation parameters assigned for each session by a constrained Bayesian optimization algorithm.

The 7 groups in the trial

  • Basolateral amygdala (BLA)Treatment being tested

    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.

    Treatment: ATTN201 head-worn focused ultrasound

  • Dorsal anterior cingulate cortex (dACC)Treatment being tested

    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.

    Treatment: ATTN201 head-worn focused ultrasound

  • Anterior limb of internal capsule (ALIC)Treatment being tested

    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.

    Treatment: ATTN201 head-worn focused ultrasound

  • Centromedian nucleus of thalamus (CMN)Treatment being tested

    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.

    Treatment: ATTN201 head-worn focused ultrasound

  • Rostral zona incerta (rZi)Treatment being tested

    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.

    Treatment: ATTN201 head-worn focused ultrasound

  • Subthalamic nucleus (STN)Treatment being tested

    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.

    Treatment: ATTN201 head-worn focused ultrasound

  • Anterior nucleus of thalamus (ANT)Treatment being tested

    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.

    Treatment: ATTN201 head-worn focused ultrasound

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Bayesian-Optimized Dose-Finding of ATTN201 Focused Ultrasound for Behavioral Health
Fit questions
Built from NCT07851038, who can take part
Record updated
27 October 2026