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| Name | Class |
|---|---|
| Hotchkiss Brain Institute, University of Calgary | OTHER |
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The proposed study is to evaluate the safety and initial efficacy of MRgFUS for patients with treatment-refractory OCD. This study is designed as a prospective, single arm, nonrandomized study. Assessments will be made before and after MRgFUS for adverse events related to treatment, for clinical symptom relief, and quality of life (QoL). The target in the brain chosen for ablation will be the anterior limb of the internal capsule (ALIC) (i.e 'capsulotomy'). Safety will be assessed prospectively in radiologic and clinical terms. Post-procedural imaging will be evaluated for evidence of swelling, hemorrhage, and the evolution of the lesion in the anterior limb of the internal capsule. Patients will be clinically followed up at Day 1, Month 1, Month 3, Month 6 and Month 12 post-procedure. At every follow-up visit, patients will be evaluated for general health, neurological changes, as well as for device/procedure related adverse events. Imaging will also be performed with positron emission tomography (PET) and MRI, as per the Month 3 and Month 12 post-procedure. Feasibility will be evaluated by determining the rate of patient accrual, the tolerability of the procedure for patients, and the technical ability of heating the ALIC to lesional temperatures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focused Ultrasound | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focused Ultrasound | Device | MR-guided Focused Ultrasound (MRgFUS) offers the possibility of lesioning deep brain targets, while obviating the need for open surgical approaches. There is no radiation, incision, or burr hole, and lesions are generated in real-time under MR image guidance. Intracranial FUS for other applications, essential tremor most notably, has been shown to be safe and effective, recently receiving Health Canada approval for this indication. The technology, methods and procedures used in this study are identical to those in essential tremor. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety] | Adverse events (AE) will be recorded and categorized according to severity and relationship to procedure | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically meaningful reduction in symptoms [Efficacy] | Primary effectiveness will be evaluated using validated scores and subscales related to the symptom being treated (i.e., Yale-Brown Obsessive Compulsive Scale). Efficacy is defined as a clinically meaningful reduction in symptoms at 12 months post-treatment. A patient with OCD is considered to have a treatment response if their YBOCS is reduced by 35% compared to baseline. |
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Inclusion Criteria:
Men and women ≥20 and ≤80 years of age.
Patients who are able and willing to give consent and able to attend study visits, as determined by both study Psychiatrist and the surgeon.
Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis of Obsessive Compulsive Disorder (OCD), at least 5-year illness history with a minimum score of 28 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
Medication-refractoriness as determined by an adequate dose and duration of standard psychiatric treatments (including psychotherapy and/or pharmacology) as determined by two psychiatrists associated with the study. Including specifically:
Able to communicate sensations during the ExAblate MRgFUS treatment
A consistent dose of all medications in the 30 days prior to study entry.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nir Lipsman, MD, PhD | Sunnybrook Health Sciences Centre, Sunnybrook Research Institute | Principal Investigator |
| Zelm Kiss, MD, PhD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothill Medical Centre | Calgary | Alberta | T2N 2T9 | Canada | ||
| Sunnybrook Health Sciences Centre |
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|
| 12 months |
| Toronto |
| Ontario |
| M4N 3M5 |
| Canada |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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