Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment Refractory Obsessive Compulsive Disorder (OCD)

NCT07704632 | Recruiting

• 1 other identifier: 6791
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the safety, feasibility, and preliminary efficacy of focused ultrasound (FUS) neuromodulation delivered using the Next Generation Dome Helmet (NGDH) in participants with treatment-refractory obsessive-compulsive disorder (OCD). Participants will undergo two study sessions, four weeks apart, involving active FUS neuromodulation targeting nodes of the cortico-striato-thalamo-cortical (CTSC) circuit. Outcomes include adverse events, changes in OCD symptom severity, and quality of life.

Conditions

OCD; Obsessive-Compulsive Disorder (OCD); Obsessive-Compulsive Disorder

Keywords

Focused ultrasound (FUS); MRgFUS; FUS Neuromodulation

Outcome Measures

Primary Outcomes (1)

• Safety and Feasibility of FUS Neuromodulation in Participants With Treatment-Refractory Obsessive-Compulsive Disorder

  Assessment of the frequency and severity of adverse events associated with focused ultrasound neuromodulation in patients with treatment-refractory obsessive-compulsive disorder. Adverse events, including procedure-related complications and neurological events, will be documented and assessed.

  Assessments will be conducted at the baseline visit; on the day of each of the two treatments; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.

Secondary Outcomes (7)

• Change in Obsessive-Compulsive Symptom Severity Measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

  Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.

• Change in Quality of Life as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

  Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.

• Change in Obsessive-Compulsive Symptoms as Measured by the Obsessive Compulsive Inventory (OCI)

  Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.

• Change in Anxiety Symptoms as Measured by the Beck Anxiety Inventory (BAI)

  Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.

• Change in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7)

  Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.

Study Arms (1)

Focused Ultrasound Neuromodulation

EXPERIMENTAL

Focused Ultrasound Neuromodulation: Participants will receive two sessions of Magnetic Resonance-guided focused ultrasound neuromodulation targeting regions within the cortical-striatal-thalamic circuit (CSTC) implicated in treatment-resistant depression. Treatments will be spaced four weeks apart. All participants will receive the same intervention and will be followed for 4 weeks post-treatment to evaluate clinical outcomes, adverse events, and depression symptoms.

Device: Next Generation Dome Helmet (NGDH)

Interventions

Next Generation Dome Helmet (NGDH) DEVICE

Participants will receive two sessions of Magnetic Resonance-guided focused ultrasound neuromodulation, spaced four weeks apart, using the Next Generation Dome Helmet device. Treatments will target regions within the CSTC circuit identified by advanced MRI scans. Each session will include pre-treatment assessments, precise sonications of deep brain structures, real-time safety monitoring, and post-treatment imaging.

Focused Ultrasound Neuromodulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be deemed to have the capacity to provide informed consent.
• Age 18 to 85 years.
• Diagnosis of obsessive-compulsive disorder according to DSM-5 criteria.
• Yale-Brown Obsessive Compulsive Scale total score greater than 22.
• If taking psychiatric medications, must be on a stable regimen for at least 30 days before enrollment. Psychiatric medications will be continued throughout the study.
• Previous trial of at least two first-line antidepressant agents at an adequate dose and duration, as assessed by two psychiatrists.
• Previous trial of cognitive behavioural therapy or psychotherapy for OCD for at least 6 weeks.

You may not qualify if:

• Pregnant or intending to become pregnant during the study.
• Substance use disorder, other than cannabis or nicotine use disorder, of moderate severity or greater, or where the substance is the primary substance of concern, according to DSM-5 criteria.
• Known active seizure disorder or significant head injury with an imaging-confirmed lesion.
• Unstable medical illness.
• Not eligible for 3-Tesla MRI, such as due to an MRI-incompatible pacemaker or other implanted device.
• Unable to reliably attend the required screening, treatment, and follow-up visits.
• Severe claustrophobia that would prevent MRI scanning.
• History of a bleeding disorder or coagulopathy.
• Anticoagulant therapy or use of medications known to increase the risk of hemorrhage within the required washout period before treatment, including:
• Antiplatelet agents or vitamin K antagonist anticoagulants within 7 days of treatment
• Non-vitamin K oral anticoagulants within 72 hours of treatment
• Heparin-derived compounds within 48 hours of treatment

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Central Study Contacts

Nir Lipsman, MD, PHD, FRCSC, FAANS

CONTACT

(416)-480-6954; Nir.Lipsman@sunnybrook.ca

Anusha Baskaran, PhD

CONTACT

416-480-6100; anusha.baskaran@sunnybrook.ca

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: Principal Investigator MD, PHD, FRCSC, FAANS

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: September 23, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)