Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment Refractory Obsessive Compulsive Disorder (OCD)
Next Generation Dome Helmet (NGDH): 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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Safety and Feasibility of FUS Neuromodulation in Participants With Treatment-Refractory Obsessive-Compulsive Disorder — 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. 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.
Trial sites (1)
Facility
City
Region
Status
Sunnybrook Health Sciences Centre
Toronto
Ontario
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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