ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders (NCT02252380) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders
Canada10 participantsStarted 2015-05
Plain-language summary
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 participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* 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.
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 intr…
What they're measuring
1
Severity of Device and Procedure Related Complications