NCT03421574

Trial of MR-guided Focused Ultrasound for Treatment of Refractory Major Depression

Phase I Trial of MR-guided Focused Ultrasound (MRgFUS) Bilateral Capsulotomy for the Treatment of Refractory Major Depression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The proposed study is to evaluate the safety and initial efficacy of MRgFUS for patients with treatment-refractory Major Depression. 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 (i.e 'capsulotomy').

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	MR-guided Focused Ultrasound	Focused Ultrasound allows for non-invasive thermal ablation of soft tissue virtually anywhere in the body. Treatment begins by acquiring a series of magnetic resonance (MR) images of the target tissue. The physician then reviews the images on the system workstation, identifies the target, delineates treatment contours, and reviews the treatment plan. Therapy planning software calculates the parameters required to effectively treat (e.g. ablate) the defined region. During treatment, the patient wears a helmet equipped with multiple sources of ultrasound which generate a point of focused energy, called a sonication. The sonication raises the tissue temperature within a well-defined region, causing a thermal coagulation effect.

Timeline

• Start date: 2018-01-19
• Primary completion: 2021-07-28
• Completion: 2021-07-28
• First posted: 2018-02-05
• Last updated: 2023-12-05

Locations

1 site across 1 country: Canada