LIFU for OCD

(LIFU Trial)

Recruiting at 2 trial locations

Overseen By Lucas Jumper, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must be taking: SRI medications

Must not be taking: Benzodiazepines

Disqualifiers: Epilepsy, Suicidal risk, Substance abuse, others

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

Compensation: Varies

Number of Visits: 15

Duration: 2 weeks

20 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. Participants must stay on their SRI medications at a stable dose for at least 2 months before and during the trial.

Is Low-Intensity Focused Ultrasound (LIFU) safe for humans?

Low-Intensity Focused Ultrasound (LIFU) is a new technique that shows promise for safely targeting deep brain areas without surgery. It is considered noninvasive and reversible, which suggests it may be safer than traditional surgical methods, but more research is needed to confirm its safety in humans. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment BX Pulsar 1002 for OCD?

The research on high-intensity focused ultrasound (HIFU), a similar technology to LIFU, shows it is effective and safe for treating various conditions like prostate issues, glaucoma, and tumors. This suggests that LIFU might also be effective for OCD, although direct evidence for OCD is not provided. ^{6 7 8 9 10}

Who Is on the Research Team?

Wayne K Goodman, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Subjects with at least moderate OCD, defined by Yale-Brown Obsessive Compulsive Scale (YBOCS) score of >19

I have been on a stable dose of SRI medication for at least 2 months.

I have tried at least two types of depression medication without success.

Exclusion Criteria

I have not had transcranial magnetic stimulation in the last 30 days.

I have tried more than four different SSRIs or clomipramine without success.

History of substance abuse including alcohol use disorder within the past 6 months (except nicotine and caffeine)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive Low Intensity Focused Ultrasound (LIFU) treatment targeting the ventral striatum for OCD

2 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Weekly visits for 8 weeks, then monthly visits

What Are the Treatments Tested in This Trial?

Interventions

• BX Pulsar 1002

Trial Overview 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.

How Is the Trial Designed?

Group I: LIFU in OCD group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

Low-intensity focused ultrasound (LIFU) is a promising noninvasive technique for neuromodulation that could improve treatment outcomes for patients with Major Depressive Disorder (MDD) and Obsessive-Compulsive Disorder (OCD) who do not respond to traditional therapies.

Current psychosurgical techniques, such as deep-brain stimulation, have variable success rates, with only about half of patients showing adequate response, highlighting the need for innovative approaches like LIFU to enhance personalized treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Definition of Surgical Targets in Major Depression and Obsessive-Compulsive Disorder: A Potential Role for Low-Intensity Focused Ultrasound? Guinjoan, SM.[2023]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

Noninvasive surgery of prostate tissue by high intensity focused ultrasound: an updated report. [2019]

2. China pubmed.ncbi.nlm.nih.gov

[High intensity focused ultrasound alone for malignant solid tumors]. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

High-intensity Focused Ultrasound Treatment in Moderate Glaucoma Patients: Results of a 2-Year Prospective Clinical Trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Extracorporeally induced ablation of renal tissue by high-intensity focused ultrasound. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Extracorporeal focused ultrasound surgery for treatment of human solid carcinomas: early Chinese clinical experience. [2016]

6. Germany pubmed.ncbi.nlm.nih.gov

New Directions for Surgical Ablation Treatment of Obsessive Compulsive Disorder. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Results of Gamma Knife anterior capsulotomy for refractory obsessive-compulsive disorder: results in a series of 10 consecutive patients. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Personalized Definition of Surgical Targets in Major Depression and Obsessive-Compulsive Disorder: A Potential Role for Low-Intensity Focused Ultrasound? [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Six-month follow-up of a randomized controlled trial augmenting serotonin reuptake inhibitor treatment with exposure and ritual prevention for obsessive-compulsive disorder. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

A study of novel bilateral thermal capsulotomy with focused ultrasound for treatment-refractory obsessive-compulsive disorder: 2-year follow-up. [2019]