Low Intensity Focused Ultrasound for Obsessive-Compulsive Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and feasibility of using low-intensity focused ultrasound to treat symptoms of obsessive-compulsive disorder (OCD). Researchers will deliver ultrasound to specific brain areas and observe changes in OCD symptoms using self-assessed scales. Participants will undergo both real and placebo (sham) ultrasound sessions to compare results. This trial may suit adults who have experienced severe OCD for at least five years, with obsessions or compulsions lasting more than an hour a day, and whose compulsions involve hand or arm movements. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could lead to new treatment options for OCD.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the research team or your doctor.
What prior data suggests that the ATTN201 device is safe for treating OCD?
Research has shown that Low Intensity Focused Ultrasound (LIFU) is generally safe. Studies have found that LIFU operates below the safety limits set by the FDA, classifying it as a Non-Significant Risk (NSR) by the FDA and Institutional Review Boards (IRBs). Trials have safely applied LIFU to the brain and other areas without causing major issues.
A small study on patients with obsessive-compulsive disorder (OCD) showed promising safety results, with no major side effects reported. The treatment is noninvasive, meaning it doesn't involve surgery, which reduces the risk of infection and blood clots.
Additionally, a detailed review of LIFU found that it can precisely target specific areas, minimizing damage to nearby tissues. Overall, LIFU is well-tolerated, with few negative effects reported in studies.12345Why are researchers excited about this trial?
Low Intensity Focused Ultrasound (LIFU) is unique because it offers a non-invasive, targeted approach to treating Obsessive-Compulsive Disorder (OCD). Unlike standard therapies like Cognitive Behavioral Therapy (CBT) or medications such as SSRIs and antipsychotics, which often take weeks to show effects and can have systemic side effects, LIFU directly targets specific brain areas involved in OCD. Researchers are excited about LIFU because it uses ultrasound waves to precisely engage brain circuits without the need for surgery, potentially offering rapid relief with fewer side effects. This precision and non-invasive nature make LIFU a promising option for those who haven't responded well to traditional treatments.
What evidence suggests that low-intensity focused ultrasound might be an effective treatment for OCD?
Research has shown that Low Intensity Focused Ultrasound (LIFU) could help treat neuropsychiatric conditions like obsessive-compulsive disorder (OCD). This trial will assess the safety and target engagement of LIFU in participants with OCD. The technique uses sound waves to target specific brain areas without harming nearby tissues. In some studies, similar ultrasound methods significantly reduced OCD symptoms, with some patients experiencing improvements of 35% to 50%. LIFU is also considered safe, with a lower risk of infection or blood clots compared to other treatments. Early findings suggest that LIFU can effectively alter brain activity in areas linked to OCD, potentially providing relief for those dealing with symptoms.12467
Who Is on the Research Team?
Katherine Scangos, MD, PhD
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
This trial is for adults aged 18-60 with severe, long-term OCD involving hand or arm movements. Participants must be able to understand instructions in English, complete study tasks, and not have other major mental or medical conditions that could interfere. People who can't undergo MRI scans or wear the device are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive low-intensity focused ultrasound (LIFU) sessions targeting subcortical brain areas to evaluate safety and target engagement
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Low Intensity Focused Ultrasound
Trial Overview
The study tests if low-intensity focused ultrasound (using the ATTN201 device) is safe and practical for treating OCD symptoms by targeting specific brain areas over four visits. Both unfocused and focused ultrasound sessions will be given.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Attune Neurosciences Inc
Industry Sponsor
Citations
NCT07558148 | OCD LIFU Target Engagement
The investigators will conduct a pilot study to evaluate the safety and feasibility of low-intensity focused ultrasound on ...
A Comprehensive Review of Low-Intensity Focused ... - PMC
Low-intensity focused ultrasound (LIFU) is gaining increased interest as a potential therapeutic modality for a range of neuropsychiatric diseases.
Obsessive-Compulsive Disorder (OCD)
It is noninvasive and has reduced risk for infection and blood clots. Focused ultrasound can also offer precise targeting to minimize damage to ...
A systematic review of focused ultrasound for psychiatric ...
Bilateral anterior capsulotomy resulted in a full responder rate of 67% (≥ 35% reduction in the Yale-Brown Obsessive-Compulsive Scale score) and 33% (≥ 50% ...
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 Ultrasound (LIFU)
A pilot study of transcranial low-intensity focused ultrasound ...
This study provides preliminary evidence supporting the safety and possible efficacy of LIFU targeted at the basal ganglia in trOCD.
Long-Term Safety and Efficacy of Focused Ultrasound ...
The primary outcome was safety. The secondary outcome was clinical response, defined for OCD as a ≥35% improvement in Yale-Brown Obsessive ...
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