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Obsessive Compulsive DisorderPhase 2NCT07728994

SONATA LIFU for OCD

A Phase 2 study testing Low Intensity Focused Ultrasound in people with Obsessive Compulsive Disorder, run by University of Pennsylvania at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The study tests ATTN201, an investigational non-invasive headband that delivers low-intensity focused ultrasound (LIFU) to the subthalamic nucleus (STN) as a treatment for obsessive-compulsive disorder (OCD). Read more about this study

Who is it for?
Ages 22 to 80 years
Conditions the study is for
Obsessive Compulsive Disorder
What is being tested?
Low Intensity Focused Ultrasound
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
1 Jul 2026to 31 Oct 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a principal diagnosis of OCD according to the DSM-5 with duration of > 1 year
  • Have a Y-BOCS of > 16
  • Participants currently on OCD medication must be at the same stable dose(s) for at least 3 weeks prior to screening and throughout the course of the study, and must continue to be under the care of their treating psychiatrist through the duration of the study.
  • Be between 22 to 80 years of age (inclusive) on the day of signing informed consent.
  • Be able and willing to undergo a cranial MRI
  • Be able and willing to wear an Attune device throughout the experimental sessions.
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  • Sign the informed consent form, in accordance with local requirements, after the scope and nature of the investigation have been explained to the subject, and before screening assessments.
  • Be able to speak, read, and understand the language of the trial staff and the informed consent form.
  • Possess the ability to respond verbally to questions, follow instructions, and complete study assessments.
  • Be able to adhere to the stimulation protocol and visit schedules.
  • Be determined by the investigator to be medically stable at baseline/randomization 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. Male participants should not father a child or donate sperm for this same period.
  • Female participants who are sexually active agree to use two methods of contraception for the duration of the study or not be of childbearing potential as indicated by one of the following:
  • Has reached natural menopause, defined as 45 years of age with ≥6 months of spontaneous amenorrhea
  • Has had a hysterectomy;
  • Has had bilateral tubal ligation; or
  • Has had a bilateral oophorectomy (with or without a hysterectomy) and greater than 6 weeks have passed since the surgery

Who cannot join

  • Has a current or prior history of bipolar I or II disorder, schizophrenia or other psychotic disorder, borderline personality disorder, Tourette's disorder
  • Has acute suicidality or suicide attempt or self-injurious behavior in the last 6 months
  • Has a history of deep brain stimulation or ablative surgery
  • Has a history of substance abuse including alcohol use disorder in the past 6 months (except for caffeine and nicotine)
  • Has a history of traumatic brain injury with loss of consciousness, seizures,or other neurological disorders.
  • Has any contraindications for completing a brain MRI scan.
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  • The subject's head must fit within the head coil (32 or 64 channel), while wearing the MR-compatible device.
  • Has had a ketamine or TMS treatment within the last month prior to recruitment.
  • Has had any medical or psychiatric symptoms or conditions that could interfere with study activities or confound interpretation of study results.
  • Has a recent or ongoing, uncontrolled, clinically significant medical condition where participation in the trial would pose a significant medical risk to the subject or would confound study results within 3 months of Screening, such as:
  • Conditions including but not limited to diabetes, hypertension, Human Immunodeficiency Virus (HIV) or other relevant infections, thyroid or endocrine disease, Chronic Obstructive Pulmonary Disease (COPD), delirium, congestive heart failure, angina, cardiac or gastrointestinal disease, or renal disease requiring dialysis, or unstable malignancies.
  • Major surgery including not limited to abdominal, thoracic, cardiac, or orthopedic surgery, or any procedure requiring general anesthesia.
  • Subjects with recently controlled or treated medical conditions may be considered for re-screening on a case-by-case basis after consultation with the Sponsor.
  • Has a history of hepatitis or liver disease that, in the opinion of the investigator, has been active within the 6 months prior to Visit 1.
  • Is pregnant, is attempting to become pregnant, or is nursing children.
  • Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is an investigational site or sponsor staff directly involved with this trial.
  • Has a Body Mass Index (BMI) >34 kg/m2. BMI is calculated by taking the subject's weight in kg and dividing by the subject's height in meters, squared

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Attune Neurosciences

    San Francisco, California, 94107

    Lena Kozyr

    Katherine Scangos, MD, PhD

    Recruiting

Other trials in United States

About this study

Official title: Safety and Feasibility Study of ATTN201 Repeated Subthalamic Nucleus Focused Ultrasound Stimulation for the Treatment of Obsessive Compulsive Disorder

The study tests ATTN201, an investigational non-invasive headband that delivers low-intensity focused ultrasound (LIFU) to the subthalamic nucleus (STN) as a treatment for obsessive-compulsive disorder (OCD). It's a randomized, double-blind, 1:1 (active: sham) study with 40 total participants spanning 12-16 weeks and 14 in-person and remote visits.

Read the detailed description

This is a randomized, double-blind, sham-controlled study evaluating the safety and feasibility of ATTN201, an investigational, non-invasive, wearable ultrasound headband, in adults with obsessive-compulsive disorder (OCD). ATTN201 uses low-intensity focused ultrasound (LIFU), guided by magnetic resonance imaging (MRI), to deliver stimulation to the subthalamic nucleus (STN), a brain region implicated in OCD symptom circuits. This is the fifth study in which ATTN201 has been used in humans, and the device is not currently approved by the U.S. Food and Drug Administration (FDA) for clinical use outside of research.

Approximately 40 participants will be enrolled in this study, ages 18-80, will be enrolled at a single site in San Francisco. Participants will be randomly assigned in a 1:1 ratio to receive either active focused ultrasound stimulation (20 participants) or sham (inactive) stimulation (20 participants). Sham stimulation sounds the same as active stimulation but does not deliver a therapeutic ultrasound effect to the brain. Neither participants nor the study staff administering treatment will know which group a participant has been assigned to during the treatment period.

Participation lasts approximately 12 to 16 weeks and includes 14 in-person and remote visits.

Being tested
Low Intensity Focused Ultrasound, Sham (No Treatment)
Keywords
OCD, LIFU
Medical subject headings
Obsessive-Compulsive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Intensity Focused UltrasoundDevice

    Also called LIFU

    ATTN201 is an investigational, non-invasive, wearable headband containing two ultrasound transducers positioned over the temporal region of the skull. Guided by a pre-treatment MRI, the device delivers focused low-intensity ultrasound (LIFU) to the subthalamic nucleus (STN).

  • Sham (No Treatment)Device

    Participants are fitted with the same ATTN201 headband used in the active arm, and the device is operated using the same procedures and audible output as active stimulation. However, the ultrasound is unfocused and does not deliver a therapeutic effect to the brain. This sham condition is designed to be indistinguishable from active stimulation to preserve blinding of participants and study staff.

Study groups in NCT07728994
Study groupRoleWhat they receive
Active StimulationExperimentalATTN201 focused ultrasound stimulation delivered to the subthalamic nucleus (STN)
Receives: Device: Low Intensity Focused Ultrasound
Sham StimulationSham comparatorATTN201 sham/unfocused stimulation - device is fitted and produces the same audible sound as active stimulation but delivers no substantive focused ultrasound effect to the brain.
Receives: Device: Sham (No Treatment)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in OCD symptom severity

    Measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Measured: up to 3 months

  2. Incidence and severity of adverse events

    Device-related and procedure-related side effects

    Measured: up to 3 months

Secondary outcomes (6)
  1. Change in Anxiety Symptoms

    Beck Anxiety Inventory

    Measured: up to 3 months

  2. Change in depressive symptoms

    Beck Depression Inventory - II (BDI-II)

    Measured: up to 3 months

  3. Change in global impression

    Clinical global impression severity and clinical global impression improvement

    Measured: up to 3 months

  4. Change in functional disability

    Sheehan Disability Scale

    Measured: up to 3 months

  5. session-level symptom change

    Visual Analog Scale ratings collected at each study intervention session

    Measured: up to 3 months

  6. Change in resting-state and task based functional connectivity

    fMRI

    Measured: up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2026
  2. Study start1 Jul 2026
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized controlled study evaluating dose duration.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07728994
Sponsor's protocol ID
25-0483
Status last verified
Jul 2026
First submitted
14 Jul 2026
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Aubry JF, Attali D, Schafer ME, Fouragnan E, Caskey CF, Chen R, Darmani G, Bubrick EJ, Sallet J, Butler CR, Stagg CJ, Klein-Flugge MC, Yoo SS, Holland CK, Treeby B, Martin E, Verhagen L, Butts Pauly K. ITRUSST consensus on biophysical safety for transcranial ultrasound stimulation. Brain Stimul. 2025 Nov-Dec;18(6):1896-1905. doi: 10.1016/j.brs.2025.10.007. Epub 2025 Oct 8.

    PubMed 41072763
  • Stern JM, Spivak NM, Becerra SA, Kuhn TP, Korb AS, Kronemyer D, Khanlou N, Reyes SD, Monti MM, Schnakers C, Walshaw P, Keselman I, Cohen MS, Yong W, Fried I, Jordan SE, Schafer ME, Engel J Jr, Bystritsky A. Safety of focused ultrasound neuromodulation in humans with temporal lobe epilepsy. Brain Stimul. 2021 Jul-Aug;14(4):1022-1031. doi: 10.1016/j.brs.2021.06.003. Epub 2021 Jun 23.

    PubMed 34198105
  • Munoz F, Meaney A, Gross A, Liu K, Pouliopoulos AN, Liu D, Konofagou EE, Ferrera VP. Long term study of motivational and cognitive effects of low-intensity focused ultrasound neuromodulation in the dorsal striatum of nonhuman primates. Brain Stimul. 2022 Mar-Apr;15(2):360-372. doi: 10.1016/j.brs.2022.01.014. Epub 2022 Jan 29.

    PubMed 35092823
  • Gaur P, Casey KM, Kubanek J, Li N, Mohammadjavadi M, Saenz Y, Glover GH, Bouley DM, Pauly KB. Histologic safety of transcranial focused ultrasound neuromodulation and magnetic resonance acoustic radiation force imaging in rhesus macaques and sheep. Brain Stimul. 2020 May-Jun;13(3):804-814. doi: 10.1016/j.brs.2020.02.017. Epub 2020 Feb 21.

    PubMed 32289711
  • Darmani G, Bergmann TO, Butts Pauly K, Caskey CF, de Lecea L, Fomenko A, Fouragnan E, Legon W, Murphy KR, Nandi T, Phipps MA, Pinton G, Ramezanpour H, Sallet J, Yaakub SN, Yoo SS, Chen R. Non-invasive transcranial ultrasound stimulation for neuromodulation. Clin Neurophysiol. 2022 Mar;135:51-73. doi: 10.1016/j.clinph.2021.12.010. Epub 2021 Dec 31.

    PubMed 35033772
  • Blackmore J, Shrivastava S, Sallet J, Butler CR, Cleveland RO. Ultrasound Neuromodulation: A Review of Results, Mechanisms and Safety. Ultrasound Med Biol. 2019 Jul;45(7):1509-1536. doi: 10.1016/j.ultrasmedbio.2018.12.015. Epub 2019 May 18.

    PubMed 31109842

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low Intensity Focused Ultrasound in people with Obsessive Compulsive Disorder, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Giovanna Rocchio (6177657150, giovanna.rocchio@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in OCD symptom severity (time frame: up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07728994, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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