LIFU for OCD

(LIFU Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new, non-invasive treatment called Low Intensity Focused Ultrasound (LIFU) for individuals with obsessive-compulsive disorder (OCD). LIFU uses high-frequency sound waves to stimulate a specific part of the brain, potentially easing OCD symptoms. Researchers aim to determine the safety and effectiveness of this approach while observing changes in brain activity. The trial suits those who have had OCD for at least two years and have not found relief with previous medication treatments. Participants will attend several sessions over two weeks and continue with follow-ups for six months. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for OCD.

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.

What prior data suggests that this device is safe for use in OCD patients?

Research has shown that Low Intensity Focused Ultrasound (LIFU) has been safely used in past studies. This technology has treated conditions like anxiety and depression, emphasizing safety and practicality. In trials, LIFU was well-tolerated, with most people experiencing few side effects. The device sends sound waves to specific brain areas without surgery, making it non-invasive.

Studies have also explored LIFU for various brain disorders, including obsessive-compulsive disorder (OCD). These studies support its potential safety and highlight its clinical use. Overall, evidence suggests that LIFU is generally safe, with mild or no significant side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BX Pulsar 1002 treatment for OCD because it uses Low-Intensity Focused Ultrasound (LIFU), a novel approach that targets specific brain regions non-invasively. Unlike standard treatments like cognitive-behavioral therapy or medications such as SSRIs, which can take weeks to show effects, LIFU offers the potential for more immediate changes by directly modulating brain activity. This method could provide a quicker and potentially more effective option for those who don't respond well to existing treatments.

What evidence suggests that LIFU is effective for OCD?

Research has shown that Low Intensity Focused Ultrasound (LIFU), which participants in this trial will receive, might help treat obsessive-compulsive disorder (OCD). Studies have found that LIFU can safely reach deep brain areas, such as the Ventral Striatum, involved in OCD behaviors. Similar technologies, like high-intensity focused ultrasound, suggest that this method could reduce OCD symptoms. Changes in OCD severity are often measured using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), and improvements have been observed after LIFU sessions. Overall, while researchers continue to study LIFU, early results are promising for people with OCD. ^{1 2 4 6 7}

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

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withpower.com

withpower.com/trial/phase-obsessive-compulsive-disorder-7-2022-068e5

LIFU for OCD · Info for Participants · Clinical Trial 2025

What data supports the effectiveness of the treatment BX Pulsar 1002 for OCD? The research on high-intensity focused ultrasound (HIFU), a similar technology ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05467085

Imaging-Guided Low Intensity Focused Ultrasound (LIFU)

Primary study endpoint for OCD severity will be change in Y-BOCS score after 6 sonication sessions compared to baseline. Y-BOCS (Yale-Brown Obsessive Compulsive ...

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trialx.com

trialx.com/clinical-trials/listings/248438/imaging-guided-low-intensity-focused-ultrasound-lifu/

Imaging-Guided Low Intensity Focused Ultrasound (LIFU)

This research study is to investigate the safety, feasibility, and possible therapeutic benefits of a technology called Low Intensity Focused ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9124976/

Clinical Intervention Using Focused Ultrasound (FUS ...

In this review, we will discuss the well-established clinical use of MRgFUS for the treatment of ET, PD, and obsessive-compulsive disorder (OCD) ...

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iocdf.org

iocdf.org/recipients/clinical-trial-of-image-guided-low-intensity-focused-ultrasound-pulsation-lifup-for-the-treatment-of-obsessive-compulsive-disorder-ocd/

Clinical trial of image-guided low-intensity focused ...

About one in three people with OCD do not get better after trying first-line treatments. For patients with severe, treatment-resistant OCD, Deep Brain ...

6.

fusfoundation.org

fusfoundation.org/posts/clinical-trial-investigates-low-intensity-focused-ultrasound-for-depression/

Clinical Trial Investigates Low-Intensity ...

A clinical trial is investigating the safety and feasibility of using low-intensity focused ultrasound to address anxiety and depression.

7.

youtube.com

youtube.com/watch?v=D_vtKDcgQiA

Clinical Trial: BX Pulsar 1002 for Obsessive-Compulsive ...

Clinical Trial: BX Pulsar 1002 for Obsessive-Compulsive Disorder (NCT05467085). 56 views · 2 years ago #ClinicalTrial #ClinicalResearch # ...