The investigators will conduct a pilot study to evaluate the safety and feasibility of low-intensity focused ultrasound on obsessive-compulsive disorder (OCD) symptoms when delivered to subcortical brain targets. The investigators will use the ATTN201 device to deliver single sessions of unfocused and focused ultrasound to up to three brain targets over 4 study visits and assess the intervention through self-rated scales of OCD symptoms.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adults aged 18-60 years old
✓. Chronic OCD (5 years preceding date of enrollment), diagnosed as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition guidelines (DSM-5)
✓. 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
✓. 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
✓. 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)
✓. 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
✓. 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
✕. Unable to undergo MRI scan
What they're measuring
1
Change in Symptom Intensity through VAS score
Timeframe: From the first visit (Visit 1) through the final visit (Visit 10), approximately 6 weeks.
2
Changes in Imaging between Pre- and Post-Intervention
Timeframe: Before the first visit (Visit 1) and after the final visit (Visit 10), approximately 6 weeks
3
Incidence of Adverse Events Assesed by Symptom Checklist
Timeframe: Immediately after each intervention session and up to 24 hours post-intervention, assessed across the intervention period (Visits 6-9).
. Inability to fit and wear the ATTN201 device for the entire
✕. 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
✕. 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
✕. 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.
✕. Have a previous injury or surgery which could affect the nerve distribution