SONATA LIFU for OCD
ConditionObsessive Compulsive Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age22-80
SponsorUniversity of Pennsylvania
About this trial
The study tests ATTN201, an investigational non-invasive headband that delivers low-intensity focused ultrasound (LIFU) to the subthalamic nucleus (STN) as a treatment for obsessive-compulsive disorder (OCD). It's a randomized, double-blind, 1:1 (active: sham) study with 40 total participants spanning 12-16 weeks and 14 in-person and remote visits.
Eligibility criteria
Qualifiers
Have a principal diagnosis of OCD according to the DSM-5 with duration of > 1 year
Have a Y-BOCS of > 16
Participants currently on OCD medication must be at the same stable dose(s) for at least 3 weeks prior to screening and throughout the course of the study, and must continue to be under the care of their treating psychiatrist through the duration of the study.
Be between 22 to 80 years of age (inclusive) on the day of signing informed consent.
Disqualifiers
Has a current or prior history of bipolar I or II disorder, schizophrenia or other psychotic disorder, borderline personality disorder, Tourette's disorder
Has acute suicidality or suicide attempt or self-injurious behavior in the last 6 months
Has a history of deep brain stimulation or ablative surgery
Has a history of substance abuse including alcohol use disorder in the past 6 months (except for caffeine and nicotine)
Trial design
Treatments tested in this trial
- Low Intensity Focused Ultrasound
- Sham (No Treatment)
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Pennsylvania
Lead sponsor
Attune Neurosciences Inc
Collaborator
Source ClinicalTrials.gov