🏛️ Verified NIH Record • Updated 2025-04-30

ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders (NCT02252380)

A Feasibility Clinical Trial of the Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for the Management of Treatment-Refractory Movement Disorders

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: InSightec

🩺 Plain-English Summary (8th-Grade Level)

The proposed study is to evaluate the effectiveness of ExAblate Transcranial MRgFUS as a tool for creating a unilateral lesion in the Vim thalamus or the globus pallidus (GPi) in patients with treatment-refractory symptoms of movement disorders.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (29 items).

Location: Sunnybrook Health Sciences Centre — Toronto, Ontario

Age range: 18 Years to 85 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Patients with unstable cardiac status including:
  • Unstable angina pectoris on medication
  • Patients with documented myocardial infarction within six months of protocol entry
  • Congestive heart failure requiring medication (other than diuretic)
  • Patients on anti-arrhythmic drugs
  • Severe hypertension (diastolic BP \> 100 on medication)
  • Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
  • History of abnormal bleeding and/or coagulopathy (including deep venous thrombosis)
  • Cerebrovascular disease (multiple CVA or CVA within 6 months)
  • Symptoms and signs of increased intracranial pressure (e.g. headache, nausea, vomiting, lethargy, and papilledema)
  • Untreated, uncontrolled sleep apnea

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

  • Sunnybrook Health Sciences Centre — Toronto, Ontario
  • Toronto Western Hospital — Toronto, Ontario

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗