Low Intensity Focused Ultrasound for Obsessive-Compulsive Disorder

Overseen By Marshall Nambiar, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Pregnancy, Neuromuscular disorder, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The investigators will conduct a pilot study to evaluate the safety and feasibility of low-intensity focused ultrasound on obsessive-compulsive disorder (OCD) symptoms when delivered to subcortical brain targets. The investigators will use the ATTN201 device to deliver single sessions of unfocused and focused ultrasound to up to three brain targets over 4 study visits and assess the intervention through self-rated scales of OCD symptoms.

Who Is on the Research Team?

Katherine Scangos, MD, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

Inclusion Criteria

Severe OCD symptoms with Y-BOCS I score of 28 or higher within two weeks prior to enrollment

Compulsions involving movement of hands and/or arms

Ability to understand procedure-related instructions and complete study assessments in English

Exclusion Criteria

Unable to undergo MRI scan due to presence of metallic implants or devices, tattoos, claustrophobia, severe anxiety, or inability to remain still

Pregnancy

Inability to fit and wear the ATTN201 device for the entire duration of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low-intensity focused ultrasound (LIFU) sessions targeting subcortical brain areas to evaluate safety and target engagement

6 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Low Intensity Focused Ultrasound

How Is the Trial Designed?

Group I: LIFU Target Engagement Group Experimental Treatment 1 Intervention

Participants in this single experimental group will undergo a series of low-intensity focused ultrasound (LIFU) sessions to evaluate safety and target engagement. Each participant will receive active LIFU stimulation at up to three personalized corticostriatal brain targets. The study utilizes a within-subject, sham-controlled design where participants receive both active LIFU and sham (placebo) stimulation across different sessions to compare physiological and clinical responses.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Attune Neurosciences Inc

Industry Sponsor

Trials

1

Recruited

30+