A Phase 1 Trial of MR-guided Focused Ultrasound (MRgFUS) Bilateral Capsulotomy for the Treatment of Refractory Major Depressive Disorder (MDD)

Project Name: A Phase 1 Trial of MR-guided Focused Ultrasound (MRgFUS) Bilateral Capsulotomy for the Treatment of Refractory Major Depressive Disorder (MDD)
Status: Closed
Primary Site: Sunnybrook Health Sciences Centre
Sponsor Organization: Sunnybrook Health Sciences Centre
Funded Date: Sep 27, 2018
Funding Period: Sep 27, 2018 - Sep 26, 2020
Funding Program: Brain Program
Category: Clinical Research
Amount Awarded: $259,400.00


A large proportion of patients with Major Depressive Disorder (MDD) remain significantly symptomatic despite optimized medical and psychotherapeutics treatments. These patients are at risk for the continued morbidity, and in some cases mortality, of untreated depression. Neurosurgical strategies, using invasive thermal ablation, have been developed and employed for over half a century, to manage patients with refractory MDD. 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. The proposed study is to evaluate the safety and initial efficacy of MRgFUS for 6 patients with treatment-refractory MDD. This study is designed as a prospective, single arm, non-randomized study. Assessments will be made before and after MRgFUS for adverse events related to treatment, for clinical symptom relief, and quality of life. 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 ALIC. 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 PET and MRI, as per the Month 3, Month 6 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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