Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment Refractory Obsessive Compulsive Disorder (OCD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Next Generation Dome Helmet (NGDH).
- Who it may be relevant to
- Registry conditions: OCD, Obsessive-Compulsive Disorder (OCD), Obsessive-Compulsive Disorder. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment Refractory Obsessive Compulsive Disorder (OCD)
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.
Detailed description
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)
Interventions
- Device 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.
Primary outcome measures
- Safety and Feasibility of FUS Neuromodulation in Participants With Treatment-Refractory Obsessive-Compulsive Disorder [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 outcome measures (7)
- Change in Obsessive-Compulsive Symptom Severity Measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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 Patient-Reported Outcomes Using Likert Scales (1-9) [Time frame: 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 Depressive Symptoms as Measured by the 17-Item Hamilton Depression Rating Scale (HAMD-17) [Time frame: 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.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Sunnybrook Health Sciences Centre — Toronto
Identifiers
NCT: NCT07704632 · 6791