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Trial of MR-guided Focused Ultrasound (MRgFUS) Bilateral Capsulotomy for the Treatment of Refractory Obsessive-compulsive Disorder (OCD)

NCT03156335 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-12-05

No results posted yet for this study

Summary

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.

Conditions

  • Obsessive-Compulsive Disorder

Interventions

DEVICE

Focused Ultrasound

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.

Sponsors & Collaborators

  • Hotchkiss Brain Institute, University of Calgary

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Nir Lipsman, MD, PhD · Sunnybrook Health Sciences Centre, Sunnybrook Research Institute

  • Zelm Kiss, MD, PhD · University of Calgary

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2020-11-18
Completion
2021-10-20

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03156335 on ClinicalTrials.gov