ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
Primary Purpose
Essential Tremor
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Transcranial ExAblate
Sham Transcranial ExAblate
Sponsored by
About this trial
This is an interventional treatment trial for Essential Tremor focused on measuring ExAblate Transcranial MRgFUS
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
- 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
Sites / Locations
- Stanford University Medical Center
- University of Maryland Medical System
- Brigham and Women's Hospital
- University of Virginia
- Swedish Medical Center
- Sunnybrook Health Sciences Centre
- Tokyo Women's Medical University (TWMU)
- Yonsei University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Transcranial ExAblate
Sham Transcranial ExAblate
Arm Description
Transcranial ExAblate
Sham Treatment with Transcranial ExAblate
Outcomes
Primary Outcome Measures
Primary Efficacy Outcome
The treated upper limb CRST subscore (CRST A + B) applicable to upper limb in the ExAblate Group will be statistically better than the Sham control Group at Month 3
Severity of Device and Procedure related complications
To evaluate the incidence and severity of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory Essential Tremor related to the ExAblate treatment
Secondary Outcome Measures
Clinical Rating Scale for Tremor Part C Score
Subject daily functionalities: as measured by CRST Part-C (subscales) Month 12 as compared to Baseline, and between treatment groups through Month 3
Durability (as measured by QUEST upper arm extremity questions) of the procedure as reflected by the efficacy data through change from baseline measures through Month 12 follow up
Quality life claims: Questionnaire for Essential Tremor (QUEST) outcome (upper extremity questions) at Months 3 change from Baseline.as compared between treatment groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01827904
Brief Title
ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
Official Title
A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InSightec
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
ExAblate Transcranial MRgFUS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcranial ExAblate
Arm Type
Experimental
Arm Description
Transcranial ExAblate
Arm Title
Sham Transcranial ExAblate
Arm Type
Sham Comparator
Arm Description
Sham Treatment with Transcranial ExAblate
Intervention Type
Device
Intervention Name(s)
Transcranial ExAblate
Other Intervention Name(s)
ExAblate, TcMRgFUS, Thalamotomy
Intervention Type
Device
Intervention Name(s)
Sham Transcranial ExAblate
Primary Outcome Measure Information:
Title
Primary Efficacy Outcome
Description
The treated upper limb CRST subscore (CRST A + B) applicable to upper limb in the ExAblate Group will be statistically better than the Sham control Group at Month 3
Time Frame
Participants will be followed from the date of treatment until study completion, approximately up to 12 months
Title
Severity of Device and Procedure related complications
Description
To evaluate the incidence and severity of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory Essential Tremor related to the ExAblate treatment
Time Frame
At the time of ExAblate Transcranial thalamotomy procedure
Secondary Outcome Measure Information:
Title
Clinical Rating Scale for Tremor Part C Score
Description
Subject daily functionalities: as measured by CRST Part-C (subscales) Month 12 as compared to Baseline, and between treatment groups through Month 3
Durability (as measured by QUEST upper arm extremity questions) of the procedure as reflected by the efficacy data through change from baseline measures through Month 12 follow up
Quality life claims: Questionnaire for Essential Tremor (QUEST) outcome (upper extremity questions) at Months 3 change from Baseline.as compared between treatment groups
Time Frame
Participants will be followed from the date of treatment until study completion, approximately up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
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
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Maryland Medical System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Tokyo Women's Medical University (TWMU)
City
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Yonsei University Medical Center
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
35995551
Citation
Yamamoto K, Sarica C, Elias GJB, Boutet A, Germann J, Loh A, Joel SE, Bigioni L, Gwun D, Gramer R, Li SX, Zemmar A, Vetkas A, Algarni M, Devenyi G, Chakravarty M, Hynynen K, Scantlebury N, Schwartz ML, Lozano AM, Fasano A. Ipsilateral and axial tremor response to focused ultrasound thalamotomy for essential tremor: clinical outcomes and probabilistic mapping. J Neurol Neurosurg Psychiatry. 2022 Aug 22:jnnp-2021-328459. doi: 10.1136/jnnp-2021-328459. Online ahead of print.
Results Reference
derived
PubMed Identifier
35932269
Citation
Cosgrove GR, Lipsman N, Lozano AM, Chang JW, Halpern C, Ghanouni P, Eisenberg H, Fishman P, Taira T, Schwartz ML, McDannold N, Hayes M, Ro S, Shah B, Gwinn R, Santini VE, Hynynen K, Elias WJ. Magnetic resonance imaging-guided focused ultrasound thalamotomy for essential tremor: 5-year follow-up results. J Neurosurg. 2022 Aug 5;138(4):1028-1033. doi: 10.3171/2022.6.JNS212483. Print 2023 Apr 1.
Results Reference
derived
PubMed Identifier
31748250
Citation
Halpern CH, Santini V, Lipsman N, Lozano AM, Schwartz ML, Shah BB, Elias WJ, Cosgrove GR, Hayes MT, McDannold N, Aldrich C, Eisenberg HM, Gandhi D, Taira T, Gwinn R, Ro S, Witt J, Jung NY, Chang JW, Rosenberg J, Ghanouni P. Three-year follow-up of prospective trial of focused ultrasound thalamotomy for essential tremor. Neurology. 2019 Dec 10;93(24):e2284-e2293. doi: 10.1212/WNL.0000000000008561. Epub 2019 Nov 20.
Results Reference
derived
PubMed Identifier
27557301
Citation
Elias WJ, Lipsman N, Ondo WG, Ghanouni P, Kim YG, Lee W, Schwartz M, Hynynen K, Lozano AM, Shah BB, Huss D, Dallapiazza RF, Gwinn R, Witt J, Ro S, Eisenberg HM, Fishman PS, Gandhi D, Halpern CH, Chuang R, Butts Pauly K, Tierney TS, Hayes MT, Cosgrove GR, Yamaguchi T, Abe K, Taira T, Chang JW. A Randomized Trial of Focused Ultrasound Thalamotomy for Essential Tremor. N Engl J Med. 2016 Aug 25;375(8):730-9. doi: 10.1056/NEJMoa1600159.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.accessdata.fda.gov/cdrh_docs/pdf15/p150038c.pdf
Learn more about this trial
ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
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