OCD LIFU Target Engagement

NCT ID
NCT07558148
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
University of Pennsylvania
Conditions
Obsessive Compulsive Disorder (OCD)

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Pilot Study to Investigate Brain Targets for Neuromodulation in Obsessive-compulsive Disorder

Enrollment: 10 participants (Estimated).

What is being studied

  • Device: Low Intensity Focused Ultrasound

Who may be eligible

Ages
18 Years to 60 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Pennsylvania, United States: 1

Sample of listed locations

  • University of Pennsylvania — Philadelphia, Pennsylvania, 19104, United States — Recruiting

Study details

Start date
March 4, 2026
Primary completion date
May 19, 2027
Completion date
May 19, 2027
First posted
April 30, 2026
Collaborators
Attune Neurosciences Inc

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07558148
Registry last updated
October 1, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07558148 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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