Imaging-Guided Low Intensity Focused Ultrasound (LIFU)

Running, not enrolling · Not applicable

Conditions studied: Obsessive-Compulsive Disorder

In brief

This research study is to investigate the safety, feasibility, and possible therapeutic benefits of a technology called Low Intensity Focused Ultrasound (LIFU) in patients with obsessive- compulsive disorder (OCD). The device used in this study transmits high frequency sound waves to a particular region of the brain called the Ventral Striatum (VS). LIFU is a non-invasive form of stimulation, which can be used to stimulate deep regions of the brain. In this study, the investigators will administer LIFU to activate the VS area of the brain while also observing this brain stimulation with an MRI machine. Other aims of this study include learning more about the patterns of brain activity associated with OCD and seeing if brain activity changes as symptoms of OCD change over time during the two weeks of LIFU stimulation. Participants in this study will be asked to perform computer administered behavioral tasks -- similar to simple computer games -- to examine whether certain features of OCD (e.g., avoidance of feared triggers) change over the course of LIFU stimulation. The treatment phase of this research study is expected to last two weeks with three weekly (total of 6) treatment sessions all carried at the MRI brain imaging center at Baylor College of Medicine. There will be at least one additional screening visit before treatment starts and a series of follow up visits over a six-month period.

Key facts

Study ID

NCT05467085

Run by

Baylor College of Medicine

People needed

20

Starts

2022-08-01

Expected to finish

2026-08-01

Last updated by the study team

2025-08-18

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Outpatients, males and females, 21-55 years of age.
• 2. Principal diagnosis of OCD according to the DSM-5 with duration of ≥2 years.
• 3. Subjects with at least moderate OCD, defined by Yale-Brown Obsessive Compulsive Scale (YBOCS) (27) score of >19.
• 4. Had trials of at least two SSRIs or one SSRI and clomipramine.
• Treatment failure/non-response: As per the MGH-TRQ-OCD, minimal or no meaningful clinical benefit despite an adequate dose and duration of treatment;
• Adequate duration: At least 8 weeks of treatment with SSRI or clomipramine
• Adequate dose: Defined by the USPI labeling
• 5. If on medication, must be maintained on SRI medications at a stable therapeutic dosage for at least 2 months prior to study entry and for the duration of the trial.
• 6. If subjects are currently undergoing Exposure and Response Prevention (ERP) treatment, they must be in the maintenance stage with stable ERP "dosing" for at least 2 months.
• 7. Willing and able to adhere to the study schedule, which requires 6 sonication/scan visits over two weeks and follow up visits for up to 6 months.

You may not qualify if…

• 1.Subjects will be excluded with a history of more than four (4) previous failed treatment trials of SSRIs or clomipramine (not including any current medication trial) given for an adequate duration at an adequate dose.
• 2. Experimental therapy, either medication or device, within past 30 days.
• 3. TMS in last 30 days.
• 4. Present suicidal risk as assessed by the investigator using the Columbia Suicide Severity Rating Scale (28) or a history of attempted suicide in the past year.
• 5. History of epilepsy or seizure (except febrile) or increased risk of seizure. (N.B. We are not aware of evidence that LIFU can induce seizures; however, we decided to incorporate similar safeguards to those used in TMS studies.
• 6. Contraindications for MRI, including any metal in the head, metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.
• 7. Subjects with significant neurological disorder or insult, ablative surgery or DBS.
• 8. History of substance abuse including alcohol use disorder within the past 6 months (except nicotine and caffeine).
• 9. Unstable medical or neurological condition
• 10. Women of childbearing potential and not using a medically accepted form of contraception such as: the consistent use of an approved hormonal contraception (birth control pill/patches, rings); an intrauterine device (IUD); Contraceptive injection (Depo-Provera); double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam); Sexual abstinence (no sexual intercourse) or sterilization.
• 11. Taking regular dose of benzodiazepines in excess of equivalent to clonazepam 4 mg per day.
• 12. Mini-Mental State Exam (MMSE) less than 24
• 13. Current or prior history, per DSM-5 criteria, of bipolar I disorder, schizophrenia or other psychotic disorders, autism or autistic spectrum disorders, borderline PD, antisocial PD, body dysmorphic disorder, hoarding disorder (symptoms of hoarding disorder as part of the OCD diagnosis are allowed, a current diagnosis of Tourette's disorder. Co-morbid depression is allowed as long as OCD is considered primary.

Where it is running

• Massachussetts General Hospital — Boston, Massachusetts, United States
• Baylor College of Medicine — Houston, Texas, United States
• MD Anderson — Houston, Texas, United States

Full record on ClinicalTrials.gov

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