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.
Inclusion Criteria:
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.
Be able and willing to undergo a cranial MRI
Be able and willing to wear an Attune device throughout the experimental sessions.
Sign the informed consent form, in accordance with local requirements, after the scope and nature of the investigation have been explained to the subject, and before screening assessments.
Be able to speak, read, and understand the language of the trial staff and the informed consent form.
Possess the ability to respond verbally to questions, follow instructions, and complete study assessments.
Be able to adhere to the stimulation protocol and visit schedules.
Be determined by the investigator to be medically stable at baseline/randomization as assessed by medical history and non-significant clinical results of a vital signs examination.
Male participants must ensure a condom is used for all sexual intercourse and follow acceptable methods of contraception for their female partner for the entire duration of the study. Male participants should not father a child or donate sperm for this same period.
Female participants who are sexually active agree to use two methods of contraception for the duration of the study or not be of childbearing potential as indicated by one of the following:
Exclusion Criteria:
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)
Has a history of traumatic brain injury with loss of consciousness, seizures,or other neurological disorders.
Has any contraindications for completing a brain MRI scan.
a. The subject's head must fit within the head coil (32 or 64 channel), while wearing the MR-compatible device.
Has had a ketamine or TMS treatment within the last month prior to recruitment.
Has had any medical or psychiatric symptoms or conditions that could interfere with study activities or confound interpretation of study results.
Has a recent or ongoing, uncontrolled, clinically significant medical condition where participation in the trial would pose a significant medical risk to the subject or would confound study results within 3 months of Screening, such as:
Is pregnant, is attempting to become pregnant, or is nursing children.
Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is an investigational site or sponsor staff directly involved with this trial.
Has a Body Mass Index (BMI) >34 kg/m2. BMI is calculated by taking the subject's weight in kg and dividing by the subject's height in meters, squared
giovanna.rocchio@pennmedicine.upenn.edu6177657150
This is a randomized controlled double-blind two-group pilot study in OCD patients. Participants and clinical outcome raters will be unaware of group assignment. Randomization codes will be generated and securely stored and will be only accessible by a designated unblinded independent person. An unblinded team member will adjust LIFU parameters and have minimal interaction with study participants.
ATTN201 focused ultrasound stimulation delivered to the subthalamic nucleus (STN)
ATTN201 sham/unfocused stimulation - device is fitted and produces the same audible sound as active stimulation but delivers no substantive focused ultrasound effect to the brain.
OCD LIFU Target Engagement
Imaging-Guided Low Intensity Focused Ultrasound (LIFU)
Targeted Circuit-Based Transcranial Focused Ultrasound Intervention for Obsessive-Compulsive Disorder TUS-OCD
Subthalamic Nucleus (STN) Stimulation and Obsessive-Compulsive Disorder (OCD)
Cognition and Ultrasound
Deep Brain Stimulation for Treatment-Resistant Obsessive Compulsive Disorder
The Use of Transcranial Ultrasound Treatment of Obsessive-Compulsive Disorder
LIFUS For Neurological Disorders