Clinical trial for Obsessive Compulsive Disorder
Official title SONATA LIFU for OCD
ClinicalTrials.gov ID: NCT07728994
What this study is testing
- What it's testing
- This study is testing whether ATTN201, a non‑invasive headband that sends low‑intensity focused ultrasound to a brain area, can help people with obsessive‑compulsive disorder.
- Who it's for
- You may be able to join if you have obsessive‑compulsive disorder and meet the study’s other criteria.
- What's involved
- You would wear a soft headband that gives a gentle ultrasound pulse to a part of your brain. You will have several clinic visits and some remote check‑ins over about three months.
- Time commitment
- The study lasts about 12 to 16 weeks with 14 in‑person or remote visits.
- Phase 2: a mid-size study of how well it works
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 80
You may be able to join if
- 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...
- 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
You likely can't join if
- Has a current or prior history of bipolar I or II disorder, schizophrenia or other psychotic disorder, borderline personality disorder, Tourette's...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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.
- Has reached natural menopause, defined as 45 years of age with ≥6 months of spontaneous amenorrhea
- Has had a hysterectomy;
- Has had bilateral tubal ligation; or
- Has had a bilateral oophorectomy (with or without a hysterectomy) and greater than 6 weeks have passed since the surgery
What rules you out
- 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.
- Conditions including but not limited to diabetes, hypertension, Human Immunodeficiency Virus (HIV) or other relevant infections, thyroid or endocrine disease, Chronic Obstructive Pulmonary Disease (COPD), delirium...
- Major surgery including not limited to abdominal, thoracic, cardiac, or orthopedic surgery, or any procedure requiring general anesthesia.
- people with recently controlled or treated medical conditions may be considered for re-screening on a case-by-case basis after consultation with the Sponsor.
- Has a history of hepatitis or liver disease that, in the opinion of the investigator, has been active within the 6 months prior to Visit 1.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.