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

Sunnybrook Health Sciences Centre20 enrolled

Overview

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.

This study is designed as a prospective, single arm, nonrandomized study aiming to evaluate safety and tolerability of transcranial focused ultrasound neuromodulation targeting CTSC circuit nodes (including VC/VS, STN, ACC, OFC, and caudate nucleus). Twenty participants with treatment-refractory OCD will be enrolled. Each participant will receive two treatment sessions (4 weeks apart)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Must be deemed to have the capacity to provide informed consent. 2. Age 18 to 85 years. 3. Diagnosis of obsessive-compulsive disorder according to DSM-5 criteria. 4. Yale-Brown Obsessive Compulsive Scale total score greater than 22. 5. 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. 6. Previous trial of at least two first-line antidepressant agents at an adequate dose and duration, as assessed by two psychiatrists. 7. Previous trial of cognitive behavioural therapy or psychotherapy for OCD for at least 6 weeks. Exclusion Criteria: 1. Pregnant or intending to become pregnant during the study. 2. 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. 3. Known active seizure disorder or significant head injury with an imaging-confirmed lesion. 4. Unstable medical illness. 5. Not eligible for 3-Tesla MRI, such as due to an MRI-incompatible pacemaker or other implanted device. 6. Unable to reliably attend the required screening, treatment, and follow-up visits. 7. Severe claustrophobia that would prevent MRI scanning. 8. History of a bleeding disorder or coagulopathy. 9. 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

Outcomes

Primary Outcomes

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.

Time frame: 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

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

Evaluate the effectiveness of FUS Neuromodulation in reducing obsessive-compulsive symptom severity using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The Y-BOCS is a clinician-administered scale assessing the severity of obsessive-compulsive symptoms. Total scores range from 0 to 40, with higher scores indicating greater symptom severity (0-7 subclinical, 8-15 mild, 16-23 moderate, 24-31 severe, and 32-40 extreme).