Recruiting
Phase 2

LIFU

Sponsor:

University of Pennsylvania

Code:

NCT07887633

Conditions

Obsessive - Compulsive Disorder

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

ATTN201 - Low Intensity Focused Ultrasound

Study Details

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

Study ID

NCT07887633

Start date

Sep 15, 2026

Status verified date

Oct, 2026

Completion date

Sep 15, 2028

Anticipated

Primary completion date

Jun 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 22-80
2. Meet DSM-V criteria for OCD ≥ 1 year with a Y-BOCS score ≥ 16
3. 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

Exclusion Criteria:

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Active Stimulation

Participants receive low intensity focused ultrasound stimulation

sham comparator: Sham Stimulation

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

Interventions

ATTN201 - Low Intensity Focused Ultrasound

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.

Primary outcome measure

  • Participant Report of Symptoms [ Time Frame: 4 weeks ]
  • Visual Analog Scale [ Time Frame: 4 weeks ]
  • Beck Depression Inventory [ Time Frame: 4 weeks ]
  • Becks Anxiety Inventory [ Time Frame: 4 weeks ]
  • Clinical Global Impression Scale [ Time Frame: 4 weeks. ]

Central Contacts and Locations

Central contacts

Rishi Suresh

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

Giovanna Rocchio

giovanna.rocchio@pennmedicine.upenn.edu

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Rishi Suresh

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

Giovanna Rocchio

giovanna.rocchio@pennmedicine.upenn.edu

Principal Investigator:

Katherine Scangos, MD, PhD

More Information

Sponsor

University of Pennsylvania

Last update posted

Oct 21, 2026

Last verified

Oct, 2026

Keywords

  • Low Intensity Focused Ultrasound
  • LIFU
  • OCD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.