SONATA LIFU for OCD

NCT07728994 | Recruiting Phase 2 DMC FDA Device

• 1 other identifier: 25-0483
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Obsessive Compulsive Disorder

Keywords

OCD; LIFU

Outcome Measures

Primary Outcomes (2)

• Change in OCD symptom severity

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

  up to 3 months

• Incidence and severity of adverse events

  Device-related and procedure-related side effects

  up to 3 months

Secondary Outcomes (6)

• Change in Anxiety Symptoms

  up to 3 months

• Change in depressive symptoms

  up to 3 months

• Change in global impression

  up to 3 months

• Change in functional disability

  up to 3 months

• session-level symptom change

  up to 3 months

Study Arms (2)

Active Stimulation

EXPERIMENTAL

ATTN201 focused ultrasound stimulation delivered to the subthalamic nucleus (STN)

Device: Low Intensity Focused Ultrasound

Sham Stimulation

SHAM COMPARATOR

ATTN201 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.

Device: Sham (No Treatment)

Interventions

Low Intensity Focused Ultrasound DEVICE

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).

Also known as: LIFU

Active Stimulation

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.

Sham Stimulation

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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;

You may not qualify if:

• 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.
• a. 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Attune Neurosciences Inc: collaborator

Study Sites (1)

Attune Neurosciences

San Francisco, California, 94107, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 41072763 BACKGROUND

• 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.

  PMID: 34198105 BACKGROUND

• 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.

  PMID: 35092823 BACKGROUND

• 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.

  PMID: 32289711 BACKGROUND

• 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.

  PMID: 35033772 BACKGROUND

• 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.

  PMID: 31109842 BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Central Study Contacts

Giovanna Rocchio

CONTACT

6177657150; giovanna.rocchio@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: This is a randomized controlled double-blind two-group pilot study in OCD patients. Participants and clinical outcome raters will be unaware of group assignment. Randomization codes will be generated and securely stored and will be only accessible by a designated unblinded independent person. An unblinded team member will adjust LIFU parameters and have minimal interaction with study participants.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Model Details: This is a randomized controlled study evaluating dose duration.

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 27, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)