Status:
TERMINATED
A Study to Evaluate the Effectiveness and Safety of ExAblate MRgFUS on Essential Tremor
Lead Sponsor:
InSightec
Conditions:
Essential Tremor
Eligibility:
All Genders
22-99 years
Phase:
NA
Brief Summary
A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects The objective of this prospective, single-arm...
Detailed Description
The objective of this prospective, multi-site, single-arm study is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory t...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Men and women age 22 years or older
- A diagnosis of ET as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder
- Have had an inadequate response to one or two oral doses of medication, per local standards. An inadequate medication trial is defined as a therapeutic dose of each medication and poor response to drug, or the development of side effects as the medication dose is titrated.
- Able to communicate sensations during the ExAblate TcMRgFUS treatment
- Exclusion criteria:
- Subjects with unstable cardiac status
- Severe hypertension (diastolic BP \> 100 on medication)
- 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 (e.g. Gadolinium or Magnevist) including advanced kidney disease
- Patient with severely impaired renal function
- History of abnormal bleeding and/or coagulopathy
- History of immunocompromise including those who are HIV positive.
- History of intracranial hemorrhage
- Cerebrovascular disease (multiple CVA or CVA within 6 months)
- Subjects with uncontrolled symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, papilledema).
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time.)
- Are participating or have participated in another clinical trial in the last 30 days
- Significant claustrophobia that cannot be managed with mild medication.
- Presence of any other neurodegenerative disease such as Parkinson-plus syndromes suspected on neurological examination.
- Presence of significant cognitive impairment
- Subjects with life-threatening systemic disease
- Subjects with a history of seizures within the past year
- Subjects with presence or history of psychosis
Exclusion
Key Trial Info
Start Date :
November 17 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2023
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT03253991
Start Date
November 17 2014
End Date
February 2 2023
Last Update
April 20 2023
Active Locations (11)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
2
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
3
Sadamoto Hospital
Ehime, Japan, 790-0052
4
Shonan Fujisawa Tokushukai Hospital
Fujisawa, Japan, 2510041