ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors

Not Applicable

Completed

Conditions: Essential Tremor

Interventions: Device: Transcranial ExAblate
Device: Sham Transcranial ExAblate

Registration Number: NCT01827904

Lead Sponsor: InSightec

Brief Summary: 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).

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 randomized to either an ExAblate treatment or an ExAblate Sham or "fake" procedure. The chance of randomization to Sham is one out of four. Subjects who are randomized to Sham Control will undergo the same procedure and follow-up visits through their Month 3 visit. After the Month 3 assessments are complete, all subjects will be unblinded and those in the Sham treated group will have the option for an actual ExAblate treatment in an unblinded fashion, as long as they still qualify for ExAblate treatment. All subjects will be followed at 6 and 12 months and for up to 5 years as directed by their doctor.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 76

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Transcranial ExAblate	Transcranial ExAblate	Transcranial ExAblate
Sham Transcranial ExAblate	Sham Transcranial ExAblate	Sham Treatment with Transcranial ExAblate

Primary Outcome Measures

Name	Time	Method
Tremor Motor Score - Clinical Rating Scale for Tremor (CRST Part A (Upper Extremity) + Part B) Percent Change From Baseline	Baseline, 3 Months post-treatment	The percent change from baseline to Month 3 follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that was used to measure treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points. Individual subject's scores at Baseline and 3 Months were used to calculate percent change from baseline and averaged across subjects. High percent change from baseline is better (shows improvement).
Number of Device and Procedure Related Adverse Events	5 Years post treatment.	The cumulative sum of adverse events was followed through Year 5 of the study.

Secondary Outcome Measures

Name	Time	Method
Tremor Motor Score - Clinical Rating Scale for Tremor (CRST) Part A (Upper Extremity) + Part B Percent Change From Baseline	Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment	The percent change from baseline to Month 3 follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that was used to measure treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points. Individual subject's scores at Baseline and Follow Up were used to calculate percent change from baseline and averaged across subjects. High percent change from baseline is better (shows improvement).
Functional Disabilities - Clinical Rating Scale (CRST) for Tremor Part C Score Percent Change From Baseline	Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment	1. Subject daily functionalities: as measured by CRST Part-C (subscales) as percent change from Baseline. CRST Part-C is an 8-item score range 0-32. Higher percent change from Baseline means better outcomes.
Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Total Percent Change From Baseline	Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment	The percent change from baseline to follow-up QUEST Summary Total was used to assess quality of life changes over time in tremor patients. The QUEST consists of five dimensions for each subject converted to a percent of the total (0-100%). The summary total is the average of the five dimensions. High percent change from baseline is better (shows improvement).
Clinical Rating Scale (CRST) Part A - Posture Score, Percent Change From Baseline (Pre-treatment)	Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment	The Posture Score is a sub-Score of the Clinical Rating Scale for Tremor CRST Part A - Posture (Treated Side Upper Extremity Posture Score). The scores range 0-12 and higher scores indicate worse outcomes. For percent improvement compared to Baseline (pre-treatment visit) higher percents mean better outcomes.

Trial Locations

Locations (8): Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Swedish Medical Center
🇺🇸
Seattle, Washington, United States
University of Virginia
🇺🇸
Charlottesville, Virginia, United States
University of Maryland Medical System
🇺🇸
Baltimore, Maryland, United States
Sunnybrook Health Sciences Centre
🇨🇦
Toronto, Ontario, Canada
Stanford University Medical Center
🇺🇸
Stanford, California, United States
Tokyo Women's Medical University (TWMU)
🇯🇵
Tokyo, Japan
Yonsei University Medical Center
🇰🇷
Seoul, Korea, Republic of