SONATA Dose Duration LIFU for OCD

NCT07887633 | Recruiting Phase 2 FDA Device

• 1 other identifier: 26-7004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is testing a new, non-invasive brain stimulation approach for adults with Obsessive Compulsive Disorder (OCD). Researchers are evaluating the safety, tolerability, and target engagement of low-intensity focused ultrasound (LIFU) directed at a brain region called the subthalamic nucleus (STN). The ultrasound is delivered using a wearable device called ATTN201 (developed by Attune Neurosciences).

Conditions

Obsessive - Compulsive Disorder

Keywords

Low Intensity Focused Ultrasound; LIFU; OCD

Outcome Measures

Primary Outcomes (5)

• Participant Report of Symptoms

  The 22-item Participant Report of Symptoms questionnaire provides granular, visit-level characterization of tolerability and symptomatic response across the treatment course, complementing the primary tolerability endpoints.

  4 weeks

• Visual Analog Scale

  The Visual Analog Scale, which assesses on a scale from 0-10 the participants obsessions, compulsions, distress, depression, energy and anxiety. This survey provides granular, visit-level characterization of tolerability and symptomatic response across the treatment course, complementing the primary tolerability endpoints.

  4 weeks

• Beck Depression Inventory

  The Beck Depression Inventory (BDI-II)allows for monitoring of unintended effects on mood, given that the STN plays a role in emotional processing and provide a broader characterization of the clinical impact of treatment. The BDI-II is an assessment used to measure severity of depression

  4 weeks

• Becks Anxiety Inventory

  The Becks Anxiety Inventory (BAI) allows for monitoring of unintended effects on anxiety, given that the STN plays a role in emotional processing and provide a broader characterization of the clinical impact of treatment. The BAI is an assessment used to measure clinical anxiety.

  4 weeks

• Clinical Global Impression Scale

  The Clinical Global Impression scale asks two questions; the severity of illness and the change in illness. This scale allows a clinician completed score to monitor unintended effects on mood and anxiety. The Clinical Global Impressions - Improvement (CGI-I) scale is used to measure how much a patient's illness has improved or worsened. The Clinical Global Impressions - Severity (CGI-S) is used to measure how severe the patient's illness is.

  4 weeks.

Study Arms (2)

Active Stimulation

EXPERIMENTAL

Participants receive low intensity focused ultrasound stimulation

Device: ATTN201 - Low Intensity Focused Ultrasound

Sham Stimulation

SHAM COMPARATOR

Participants received unfocused ultrasound, which mimic the auditory and peripheral sensations of active stimulation without delivering meaningful pressure to the brain target

Device: ATTN201 - Low Intensity Focused Ultrasound

Interventions

ATTN201 - Low Intensity Focused Ultrasound DEVICE

Low-intensity focused ultrasound (LIFU) will be administered using the Attune ATTN201 device. The intervention is targeted bilaterally to the Sub-thalamic Nucleus (STN) region of the brain. All participants receive 4 sessions in their assigned condition (active LIFU or Sham) and, if patient-level stopping criteria are not met, continue in that same assigned condition to a total of 8 sessions, twice weekly over approximately 4 weeks.

Active Stimulation; 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:

• Age 22-80
• Meet DSM-V criteria for OCD ≥ 1 year with a Y-BOCS score ≥ 16
• Must be on the same stable dose(s) of OCD medication for at least 4 weeks prior to screening and throughout the course of the study

You may not qualify if:

• Co-morbid psychiatric disorder other than depression or anxiety disorder
• Active suicidal risk (defined by C-SSRS)
• History of neurological condition
• Pregnant or breastfeeding, or planning to become pregnant during the study period

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (11)

• 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

• Pallanti S, Quercioli L. Treatment-refractory obsessive-compulsive disorder: methodological issues, operational definitions and therapeutic lines. Prog Neuropsychopharmacol Biol Psychiatry. 2006 May;30(3):400-12. doi: 10.1016/j.pnpbp.2005.11.028. Epub 2006 Feb 28.

  PMID: 16503369 BACKGROUND

• 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 C, Treeby B, Martin E, Verhagen L, Pauly KB. ITRUSST Consensus on Biophysical Safety for Transcranial Ultrasound Stimulation. ArXiv [Preprint]. 2025 Oct 9:arXiv:2311.05359v3.

  PMID: 41281204 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

• 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

• Kim H, Chiu A, Lee SD, Fischer K, Yoo SS. Focused ultrasound-mediated non-invasive brain stimulation: examination of sonication parameters. Brain Stimul. 2014 Sep-Oct;7(5):748-56. doi: 10.1016/j.brs.2014.06.011. Epub 2014 Jul 2.

  PMID: 25088462 BACKGROUND

• Pasquinelli C, Hanson LG, Siebner HR, Lee HJ, Thielscher A. Safety of transcranial focused ultrasound stimulation: A systematic review of the state of knowledge from both human and animal studies. Brain Stimul. 2019 Nov-Dec;12(6):1367-1380. doi: 10.1016/j.brs.2019.07.024. Epub 2019 Jul 31.

  PMID: 31401074 BACKGROUND

• Yoon K, Lee W, Lee JE, Xu L, Croce P, Foley L, Yoo SS. Effects of sonication parameters on transcranial focused ultrasound brain stimulation in an ovine model. PLoS One. 2019 Oct 24;14(10):e0224311. doi: 10.1371/journal.pone.0224311. eCollection 2019.

  PMID: 31648261 BACKGROUND

• Caulfield KA, Sege CT, Weaver J, Murphy KR, Passaro T, Meads K, Dadgar-Kiani E, Antonucci MU, Good C, McTeague LM. Focused ultrasound to bilateral thalamic nuclei significantly improves human cognitive attention in a frequency- and intensity-dependent manner. Brain Stimul. 2026 Sep-Oct;19(5):103171. doi: 10.1016/j.brs.2026.103171. Epub 2026 Jul 21.

  PMID: 42480914 BACKGROUND

• Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chereau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardes S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Verin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514.

  PMID: 19005196 BACKGROUND

• Alonso P, Cuadras D, Gabriels L, Denys D, Goodman W, Greenberg BD, Jimenez-Ponce F, Kuhn J, Lenartz D, Mallet L, Nuttin B, Real E, Segalas C, Schuurman R, du Montcel ST, Menchon JM. Deep Brain Stimulation for Obsessive-Compulsive Disorder: A Meta-Analysis of Treatment Outcome and Predictors of Response. PLoS One. 2015 Jul 24;10(7):e0133591. doi: 10.1371/journal.pone.0133591. eCollection 2015.

  PMID: 26208305 BACKGROUND

MeSH Terms

Conditions

Compulsive Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Katherine Scangos, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rishi Suresh

CONTACT

215-746-8901; rishi.suresh1@pennmedicine.upenn.edu

Giovanna Rocchio

CONTACT

giovanna.rocchio@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Model Details: participants are randomized 1:1 to active or sham stimulation and remain in their assigned condition throughout

Study Record Dates

• First Submitted: September 30, 2026
• First Posted: October 21, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): September 15, 2028
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)