Low-intensity focused ultrasound targeting for OCD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The pilot uses the ATTN201 device to deliver single sessions of unfocused and focused low-intensity focused ultrasound to up to three subcortical brain targets across four study visits. Adults with chronic DSM-5–diagnosed OCD who are enrolled under IRB #853085 will be recruited. Safety and feasibility will be monitored and symptom changes will be measured using self-rated OCD scales before and after interventions. Results will determine whether target engagement and symptom trends support larger clinical trials.

Why it matters

Who can join: the full rules

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Adults aged 18-60 years old
2. Chronic OCD (5 years preceding date of enrollment), diagnosed as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition guidelines (DSM-5)
3. Presence of obsessions, compulsions, or both time-consuming obsessions and compulsions that take more than one hour a day or cause significant distress or impairment in social, occupation, or other important areas of functioning Obsessive-compulsive symptoms that are not attributable to the physiological effects of a substance (e.g., a drug of abuse, a medication) or another medical condition
4. Disturbance not better explained by the symptoms of another mental disorder listed in the DSM-5 Severe OCD symptoms, as defined by Y-BOCS I score of 28 or higher, within two weeks prior to enrollment
5. Compulsions need to involve movement of the hands and/or arms so that the sleeve is able to detect participant's actions (cannot be solely mental or verbal compulsions)
6. Ability to understand procedure-related instructions and to complete study assessments in English, and ability to comply with protocol requirements (e.g., procedure visits, treatment schedule, follow-up visit schedule, evaluations, etc.), in the opinion of the Principal Investigator
7. Willingness and ability to provide written agreement to allow any and all forms of communication between the research team and treating clinician(s)
8. Willingness and ability to provide informed consent, in the opinion of the Principal Investigator

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Unable to undergo MRI scan

   * Presence of metallic implants or devices or tattoos
   * Claustrophobia or severe anxiety
   * Inability to remain still for duration of scan
2. Inability to fit and wear the ATTN201 device for the entire
3. Hearing loss that, in the opinion of the Principal Investigator, an audiologist, or a treating physician, is likely to affect the subject's ability to comply with all of the requirements of the study, or may affect the integrity of the study data
4. Pregnancy - this is an exclusion criterion because we will be intentionally increasing anxiety in participants to evaluate optimal strategies to provoke distress and then promote relaxation
5. Any past or present medical condition, disease, disorder, or injury that, in the opinion of the Principal Investigator, may reduce or hinder the subject's ability to fully comply with all study requirements for the duration of the study or may impact, compromise, or affect the integrity of the data or results of the study.
6. Have a previous injury or surgery which could affect the nerve distribution
7. Have nerve damage (neuropathy)
8. Have a diagnosed neuromuscular disorder
9. Have a pacemaker
10. Have a history of skin allergies, psoriasis eczema, dermatitis, or other skin inflammation conditions
11. Compulsions cannot be completely mental or verbal actions, such as repeating words, counting objects, or performing mental rituals, and cannot involve only facial muscles/actions such as blinking or staring

Where it's running

• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Katherine Scangos, MD, PhD — University of Pennsylvania
• Study coordinator: Rishi Suresh, MD
• Email: rishi.suresh1@pennmedicine.upenn.edu
• Phone: 215-746-8901

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Focused ultrasound for mood and anxiety disorders

  This study tests whether repeated low-intensity focused ultrasound using the ATTN201 device can help people with subsyndromal to moderate depression, anxiety, or OCD.

  Recruiting Attune Neurosciences Inc · San Francisco, California and 1 other locations · NCT07851038

• Predicting Treatment Response in Psychiatric Disorders Using Biological Markers

  This study tests whether biological markers can predict which patients with psychiatric conditions will respond to treatment.

  Recruiting Centre Hospitalier St Anne · Paris · NCT07741981

• Safety and feasibility of a next-generation dome helmet for neuromodulation in OCD

  This study tests whether a new focused ultrasound helmet can safely help people with treatment-refractory OCD see if their symptoms improve.

  Recruiting Sunnybrook Health Sciences Centre · Toronto, Ontario · NCT07704632

• Bergen Four-Day Treatment for OCD, in Finland

  This trial tests whether the Bergen Four-Day Treatment for OCD can be implemented in Finnish psychiatric care to help people with OCD see if the intensive program works in a real-world setting.

  Recruiting Tampere University Hospital · Tampere · NCT07644130

• Test different deep TMS coils and targets to treat OCD

  This study tests whether different deep TMS coils and brain targets help reduce OCD symptoms in adults with OCD, using a double-blind setup with sham and active stimulation.

  Recruiting Taipei Veterans General Hospital, Taiwan · Taipei · NCT07587112

• Role of theta brain waves in how kids control thoughts and actions

  This study tests whether theta-frequency brain activity can reveal how children with ADHD or OCD, and healthy kids, manage thinking and behavior during tasks.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07566468

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.