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

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ClinicalTrials.gov Identifier: NCT03156335
Recruitment Status : Recruiting
First Posted : May 17, 2017
Last Update Posted : November 2, 2020
Sponsor:
Collaborator:
Hotchkiss Brain Institute, University of Calgary
Information provided by (Responsible Party):
Dr. Nir Lipsman, Sunnybrook Health Sciences Centre

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Device: Focused Ultrasound Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Phase I Trial of MR-guided Focused Ultrasound (MRgFUS) Bilateral Capsulotomy for the Treatment of Refractory Obsessive-compulsive Disorder (OCD)
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : April 20, 2021
Estimated Study Completion Date : April 20, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Focused Ultrasound 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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety] [ Time Frame: 12 months ]
    Adverse events (AE) will be recorded and categorized according to severity and relationship to procedure


Secondary Outcome Measures :
  1. Clinically meaningful reduction in symptoms [Efficacy] [ Time Frame: 12 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women ≥20 and ≤80 years of age.
  2. Patients who are able and willing to give consent and able to attend study visits, as determined by both study Psychiatrist and the surgeon.
  3. 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).

  4. 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:

    1. Failed adequate trial of three or more medications accepted as first line in the treatment of OCD
    2. Attempted augmentation, if tolerated, by at least 2 medications known to be first line treatments for OCD
    3. An adequate trial of cognitive behavioural therapy, delivered by a therapist experienced in treating OCD
  5. Able to communicate sensations during the ExAblate MRgFUS treatment
  6. A consistent dose of all medications in the 30 days prior to study entry.

Exclusion Criteria:

  1. Patients with unstable cardiac status [e.g. Unstable angina pectoris on medication, Patients with documented myocardial infarction within six months, Congestive heart failure requiring medication (other than diuretic), Patients on anti-arrhythmic drugs, Severe hypertension (diastolic BP > 100 on medication)]
  2. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
  3. Known intolerance or allergies to MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
  4. Severely impaired renal function (estimated glomerular filtration rate < 30ml/min/1.73 m2) or receiving dialysis
  5. Laboratory biochemical evidence of abnormal bleeding and/or coagulopathy, including risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter or abnormal INR)
  6. Cerebrovascular disease (e.g. cerebrovascular accident within 6 months) or history of intracranial hemorrhage
  7. Untreated, uncontrolled sleep apnea
  8. Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure
  9. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment
  10. Are participating or have participated in another clinical trial in the last 30 days
  11. Patients unable to communicate with the investigator and staff.
  12. Presence of significant cognitive impairment
  13. Presence of psychosis on clinical evaluation.
  14. Patients with brain tumors already known or revealed on pretreatment MRI
  15. Currently pregnant (as determined by history and serum HCG) or lactating.
  16. Chemical abuse or dependence within the previous six months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156335


Contacts
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Contact: Anusha Baskaran, PhD 416-480-6100 ext 1650 anusha.baskaran@sunnybrook.ca

Locations
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Canada, Alberta
Foothill Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Zelma Kiss, MD, PhD       zkiss@ucalgary.ca   
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Anusha Baskaran, PhD    416-480-6100 ext 1650    anusha.baskaran@sunnybrook.ca   
Contact: Benjamin Davidson, MD       benjamin.davidson@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Hotchkiss Brain Institute, University of Calgary
Investigators
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Principal Investigator: Nir Lipsman, MD, PhD Sunnybrook Health Sciences Centre, Sunnybrook Research Institute
Principal Investigator: Zelm Kiss, MD, PhD University of Calgary
More Information
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Responsible Party: Dr. Nir Lipsman, Neurosurgeon, Scientist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03156335    
Other Study ID Numbers: 002-2017
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: November 2, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders