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

Essential Tremor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827904
• Other study ID #: ET002
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: February 24, 2021

Study information

• Verified date: March 2024
• Source: InSightec
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: February 24, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

Device:
• Transcranial ExAblate

• Sham Transcranial ExAblate

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Japan	Tokyo Women's Medical University (TWMU)	Tokyo
Korea, Republic of	Yonsei University Medical Center	Seoul
United States	University of Maryland Medical System	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Swedish Medical Center	Seattle	Washington
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
InSightec

Countries where clinical trial is conducted

United States,  Canada,  Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tremor Motor Score - Clinical Rating Scale for Tremor (CRST Part A (Upper Extremity) + Part B) Percent Change From Baseline	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).	Baseline, 3 Months post-treatment
Primary	Number of Device and Procedure Related Adverse Events	The cumulative sum of adverse events was followed through Year 5 of the study.	5 Years post treatment.
Secondary	Tremor Motor Score - Clinical Rating Scale for Tremor (CRST) Part A (Upper Extremity) + Part B Percent Change From Baseline	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).	Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment
Secondary	Clinical Rating Scale (CRST) Part A - Posture Score, Percent Change From Baseline (Pre-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.	Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment
Secondary	Functional Disabilities - Clinical Rating Scale (CRST) for Tremor Part C Score Percent Change From Baseline	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.	Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment
Secondary	Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Total Percent Change From Baseline	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).	Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment