LIFU for OCD (LIFU Trial)

Palo Alto (17 mi)

Overseen byWayne K Goodman, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Baylor College of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a new treatment called Low Intensity Focused Ultrasound (LIFU) for people with OCD who haven't responded to usual treatments. LIFU uses sound waves to stimulate a specific brain area, aiming to improve symptoms. The study will observe changes in brain activity and OCD symptoms over a short period of treatment.

Eligibility Criteria

This trial is for adults aged 21-55 with a main diagnosis of OCD lasting over 2 years. They must have tried at least two types of SSRIs or one SSRI and clomipramine without success, and if on medication, it should be stable for 2 months before the study. Women must use contraception, and participants can't have had more than four failed SSRI/clomipramine treatments.

Treatment Details

The trial tests Low Intensity Focused Ultrasound (LIFU) using BX Pulsar 1002 to stimulate the brain's Ventral Striatum region in patients with OCD. It's non-invasive and paired with MRI scans to observe changes in brain activity related to OCD symptoms during six sessions over two weeks.

1Treatment groups

Experimental Treatment

Group I: LIFU in OCD groupExperimental Treatment1 Intervention

Each subject will receive 3 LIFU sessions epr week for two weeks (6 total image-guided treatments). A total of 20 sonications will be administered to one side of the head, with a derated (based on FDA standard of 0.3 dB/cm-MHz) spatial-peak temporal-average intensity (i.e., Ispta) of approximately 720mW/cm2, each lasting 30 s, separated by 30 s pause intervals. Thus, total duration of sonication will be 10 minutes, the same as used in our study of VS LIFU in healthy subjects. Sonication will be administered within a 3T Siemens Prisma scanner. During sonication, we will use the 20-channel head coil as the 32-or 64-channel coil does not allow enough space to fit the transducer. In summary, the entire sequence of 20 sonications, each lasting 30s, separated by 30s pause intervals, will be administered over 20 minutes for a total duration of sonication equal to 10 minutes.