Imaging-Guided Low Intensity Focused Ultrasound (LIFU)

NCT05467085 | Active Not Recruiting DMC FDA Device

• 1 other identifier: H-51465
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD; LIFU; Low Intensity Focused Ultrasound

Outcome Measures

Primary Outcomes (4)

• Acute changes in domains of mood, anxiety, alertness in response to VS LIFU after each sonication session as assessed by the Likert scale.

  This outcome measure will utilize the "Likert Scale" to assess the measure.This scale allows subjects to measure their mood, anxiety, and alertness by marking a scale numbered 0 through 4 with 0 being "Not at All" and 4 being "Extremely." This scale includes several items in which the subjects can indicate how they feel (Positive, negative, anxious, energetic, etc.).

  6 months

• Primary study endpoint for OCD severity will be change in Y-BOCS score after 6 sonication sessions compared to baseline.

  Y-BOCS (Yale-Brown Obsessive Compulsive Scale) is a scale utilized to measure OCD. This scale includes a section in which subjects may mark "current/past" to indicate obsessions and compulsions. This scale also includes a section where subjects can indicate any obsessions or compulsions on a scale of 0 (no symptoms) to 5 (near constant symptoms). A reduction of 35% will be deemed a responder.

  6 months

• Safety and tolerability will be assessed using the frequency of subjects with serious adverse events (SAEs), AEs leading to discontinuation, and AEs judged to be related to LIFU.

  Any AE's reported by the subject will be reviewed by the study PI to determine if an event caused harm or placed a subject/non-subject at an increased risk of harm, if the event was foreseeable, if the event is related or will impact research activities, and the specificity and severity of the event. AE's will be reported according to BCM reporting requirements.

  6 months

• Feasibility will be evaluated by determining the tolerability of the procedure for subjects as assessed by the Likert scale, and the technical ability of LIFU to modulate the desired target by MRI review.

  The feasibility of this outcome measure works in tandem with Outcome 1 of "acute changes in mood, anxiety, and alertness" in that the Likert scale also allows us to determine the tolerability of the procedures based on the subject responses. Technical ability of LIFU to modulate the desired target via regional target engagement as reflected in changes in cerebral blood flow (CBF) using arterial spin labeling (ASL) perfusion MRI after stimulation as compared to baseline (CBF). Neurocircuit target engagement is also reflected in changes in effective connectivity from BOLD fMRI

  6 months

Study Arms (1)

LIFU in OCD group

EXPERIMENTAL

Each subject will receive 3 LIFU sessions epr week for two weeks (6 total image-guided treatments). A total of 20 sonications will be administered to one side of the head, with a derated (based on FDA standard of 0.3 dB/cm-MHz) spatial-peak temporal-average intensity (i.e., Ispta) of approximately 720mW/cm2, each lasting 30 s, separated by 30 s pause intervals. Thus, total duration of sonication will be 10 minutes, the same as used in our study of VS LIFU in healthy subjects. Sonication will be administered within a 3T Siemens Prisma scanner. During sonication, we will use the 20-channel head coil as the 32-or 64-channel coil does not allow enough space to fit the transducer. In summary, the entire sequence of 20 sonications, each lasting 30s, separated by 30s pause intervals, will be administered over 20 minutes for a total duration of sonication equal to 10 minutes.

Device: BX Pulsar 1002

Interventions

BX Pulsar 1002 DEVICE

Imaging-Guided Low Intensity Focused Ultrasound Pulsation (LIFU) device

Also known as: Low Intensity Focused Ultrasound Pulsation (LIFUP)

LIFU in OCD group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Outpatients, males and females, 21-55 years of age.
• \. Principal diagnosis of OCD according to the DSM-5 with duration of ≥2 years.
• \. Subjects with at least moderate OCD, defined by Yale-Brown Obsessive Compulsive Scale (YBOCS) (27) score of \>19.
• \. 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
• \. 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.
• \. 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.
• \. 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:

• 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.
• \. Experimental therapy, either medication or device, within past 30 days.
• \. TMS in last 30 days.
• \. 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.
• \. 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.
• \. 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.
• \. Subjects with significant neurological disorder or insult, ablative surgery or DBS.
• \. History of substance abuse including alcohol use disorder within the past 6 months (except nicotine and caffeine).
• \. Unstable medical or neurological condition
• \. 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.
• \. Taking regular dose of benzodiazepines in excess of equivalent to clonazepam 4 mg per day.
• \. Mini-Mental State Exam (MMSE) less than 24
• \. 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Massachusetts General Hospital: collaborator
• M.D. Anderson Cancer Center: collaborator

Study Sites (3)

Massachussetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Wayne Goodman, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair/Professor

Model Details: This open-label early feasibility study will be conducted in 20 subjects with OCD across two centers, Baylor College of Medicine (BCM)and Massachusetts General Hospital (MGH).

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 20, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 18, 2025

Record last verified: 2025-08

Locations

US (3)