A Continued Access Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects

InSightec7 sites in 1 country61 target enrollmentApril 2015

ConditionsEssential Tremor

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Essential Tremor
Sponsor: InSightec
Enrollment: 61
Locations: 7
Primary Endpoint: Number of Device and Procedure Related Adverse Events.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this prospective, multi site, single-arm study is to capture the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in patients with essential tremor (ET).

Detailed Description

This study is evaluating a new technique for performing Thalamotomy for tremor control. While current techniques have possible invasive or radiation effects, the use of ExAblate if totally non-invasive and without any radiation. After informed consent and screening, eligible subjects will be undergo an ExAblate treatment. All subjects will be followed at 1 day, 1 week, 1, 3, 6 and 12 months and for up to 5 years as directed by their doctor.

Registry

clinicaltrials.gov

Start Date

April 2015

End Date

March 10, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

InSightec

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of Device and Procedure Related Adverse Events.

Time Frame: 5 Years post treatment

The cumulative sum of adverse events was followed through Year 5 of the study.

Secondary Outcomes

Tremor Motor Score - Clinical Rating Scale for Tremor (CRST) Part A (Upper Extremity) + Part B Scores Summed(Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment)
Clinical Rating Scale for Tremor (CRST Part A) Posture Score Change From Baseline(Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment)
Quality of Life in Essential Tremor Total (QUEST)(Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment)
Clinical Rating Scale for Tremor Part C - Activities of Daily Living.(Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment)