SONATA LIFU for OCD

Part of paid clinical trials in San Francisco, California.

Sponsor
University of Pennsylvania
Study ID
NCT07728994
Phase
PHASE2
Status
Recruiting
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Conditions

  • Obsessive Compulsive Disorder

Eligibility Criteria

Sex
ALL
Age
22 Years - 80 Years
Healthy Volunteers
Not accepted

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).
  • 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 Details

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.

Key Dates

First listed
Jul 27, 2026
Start date
Jul 1, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Active Stimulation
    ATTN201 focused ultrasound stimulation delivered to the subthalamic nucleus (STN)
  • Sham Comparator: Sham Stimulation
    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.

Primary Outcome Measure

Change in OCD symptom severity [ Time Frame: up to 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Attune NeurosciencesSan FranciscoCalifornia94107
Lena Kozyr
Katherine Scangos, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Attune Neurosciences· San Francisco, CA

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