OCD LIFU Target Engagement
ConditionObsessive Compulsive Disorder (OCD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Low Intensity Focused Ultrasound
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Pennsylvania
Lead sponsor
Attune Neurosciences Inc
Collaborator
Source ClinicalTrials.gov