Focused Ultrasound for Behavioral Health
Bayesian-Optimized Dose-Finding of ATTN201 Focused Ultrasound for Behavioral Health
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 22 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 300 visits
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "After approximately 300 visits, the Sponsor and ARPA-H convene a joint review and select 3-5 targets for continued Bayesian optimization in Stage 2."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests repeated low-strength, focused sound waves sent to deep parts of the brain using the ATTN201 device. It checks safety and possible benefits for adults ages 22–80 with mild to moderate symptoms of depression, anxiety, or obsessive-compulsive disorder (OCD). Every session uses active treatment; there is no fake treatment or placebo.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 22–80 and have at least one qualifying symptom score: depression (PHQ-9) 5–16, anxiety (GAD-7) 5–14, or OCD (OCI-R) 14–27. OCD involves unwanted thoughts or repeated actions.
- If taking mental health medicines, have stayed on the same doses for at least 4 weeks before screening and agree to keep them unchanged during treatment.
- Be able to have a brain MRI scan and use the ATTN201 device. Be willing to try monitoring devices; the portable EEG, which records brain activity, is optional.
- Speak, read, and understand English. Be able to answer questions aloud, follow directions, complete study tests, and use a smartphone and the Attune platform.
- Sign the consent form before screening. Be willing and able to follow all study steps and visits, including follow-up for 3 months after treatment.
- The study doctor must find you medically stable and likely to complete the study.
- Men must use condoms for all sex and follow the study's birth control rules for female partners during the study and for 90 days after the last visit. Do not father a child or donate sperm during that time.
- Sexually active women must use two birth control methods during the study and for 30 days after the last visit, unless they meet the study's rules for not being able to become pregnant.
Who can't join
- A suicide screening score of 3 or higher on the C-SSRS, or any suicide attempt in the past 12 months.
- Starting, stopping, or changing the dose of a mental health medicine within 4 weeks before screening, or a severe or unstable health condition that makes study participation unsafe or difficult.
- An active, unstable alcohol or drug use disorder in the past 6 months, except caffeine or nicotine. People on stable medicine-based treatment for at least 6 months may qualify.
- A past moderate or severe brain injury, a mild brain injury in the past 12 months, a seizure disorder, or brain or spinal cord damage known to raise seizure risk.
- Anything that prevents a safe brain MRI, such as certain metal implants or a pacemaker, or a body mass index (BMI, a measure based on height and weight) over 40.
- Being pregnant, trying to become pregnant, or breastfeeding.
- An allergy or sensitivity to ultrasound gel, silicone, or monitoring-device adhesives, or a skin condition where sensors go that prevents wearing the device.
- Receiving an experimental drug or device in another study within 30 days before screening, or being trial staff—or an immediate family member of staff—directly involved in this study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Any change in psychiatric medication (start, stop, or dose change) within 4 weeks prior to 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 any contraindications for completing a brain MRI scan (e.g., pacemaker, ferromagnetic implants). * 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. * 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. * Has received an investigational drug or device in another clinical study within 30 days before screening
Study sites (1)
CA
- Attune Neurosciences, Inc. · San Francisco, CA 94107More trials in San Francisco