NCT01827904

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
4 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 10, 2013

Completed
21 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2021

Completed
3 years until next milestone

Results Posted

Study results publicly available

March 13, 2024

Completed
Last Updated

August 27, 2024

Status Verified

March 1, 2024

Enrollment Period

7.8 years

First QC Date

March 27, 2013

Results QC Date

October 4, 2023

Last Update Submit

August 2, 2024

Conditions

Essential Tremor

Keywords

ExAblate Transcranial MRgFUS

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Transcranial ExAblate

EXPERIMENTAL

Transcranial ExAblate

Device: Transcranial ExAblate

Sham Transcranial ExAblate

SHAM COMPARATOR

Sham Treatment with Transcranial ExAblate

Device: Sham Transcranial ExAblate

Interventions

Transcranial ExAblateDEVICE
Also known as: ExAblate, TcMRgFUS, Thalamotomy
Transcranial ExAblate
Sham Transcranial ExAblateDEVICE
Sham Transcranial ExAblate

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

University of Maryland Medical System

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Tokyo Women's Medical University (TWMU)

Tokyo, 162-8666, Japan

Location

Yonsei University Medical Center

Seoul, 120-752, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 35995551DERIVED

  • 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.

    PMID: 35932269DERIVED

  • 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.

    PMID: 31748250DERIVED

  • 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.

    PMID: 27557301DERIVED

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Nadir Alikacem, SVP Global Regulated Clinical Affairs
Organization
Insightec
nadira@insightec.com
214-360-9900

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2013

First Posted

April 10, 2013

Study Start

May 1, 2013

Primary Completion

February 24, 2021

Study Completion

February 24, 2021

Last Updated

August 27, 2024

Results First Posted

March 13, 2024

Record last verified: 2024-03

Locations

US(5)JP(1)KR(1)CA(1)