Essential Tremor | ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
Essential Tremor research study
What is the primary objective of this study?
The objective of this prospective, randomized, double-blind (to subjects, local site's blinded assessor and Tremor Core Lab assessors), crossover, multi-site, two-arm study (ExAblate treated arm Vs ExAblate Sham treated control arm) is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in subjects with essential tremor (ET).
Who is eligible to participate?
Inclusion Criteria: - Men and women, age 22 years and older - Subjects who are able and willing to give informed consent and able to attend all study visits - Subjects with a diagnosis of Essential Tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder - Subject exhibits a significant disability from their ET despite medical treatment - Subjects should be on a stable dose of all ET medications for 30 days prior to study entry - Subject is able to communicate sensations during the ExAblate Transcranial procedure Exclusion Criteria: - Subjects with unstable cardiac status - Severe hypertension - Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc. - Known intolerance or allergies to the MRI contrast agent including advanced kidney disease or severely impaired renal function - Significant claustrophobia that cannot be managed with mild medication - Current medical condition resulting in abnormal bleeding and/or coagulopathy - 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 - History of intracranial hemorrhage - History of multiple strokes, or a stroke within past 6 months - Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment - Are participating or have participated in another clinical trial in the last 30 days - Subjects unable to communicate with the investigator and staff - Subjects with a history of seizures within the past year - Subjects with brain tumors
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Sham Transcranial ExAblate
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Transcranial ExAblateTranscranial ExAblate
Sham Transcranial ExAblateSham Treatment with Transcranial ExAblate
Active, not recruiting
Start Date: May 2013
Completed Date: December 2019
Primary Outcome: Primary Efficacy Outcome
Secondary Outcome: Quality of Life
Study sponsors, principal investigator, and references
Lead Sponsor: InSightec