Who is eligible for clinical trial NCT02252380?

Participants must meet protocol criteria for Movement Disorders. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT02252380 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-04-30

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

🔵 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

📋 "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).

Men and women, between 18 and 85 years, inclusive.
Subjects who are able and willing to give consent and able to attend all study visits.
A movement disorder symptom that has been deemed treatment-refractory by a movement disorder neurologist, including: o akathisia, akinesia, athetosis, bradykinesia, chorea, dystonia, tremor, myoclonus, dyskinesia, spasms, tics
Medication-refractoriness as determined by an adequate dose and duration of standard movement disorders treatment as determined by a specialist neurologist (e.g. a trial of primidone and propranolol for ET)
Able to communicate sensations during the ExAblate Neuro treatment
Stable doses of all medications for 30 days prior to study entry and for the duration of the study.

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.

🏛️ View Official NIH Record ↗