search
Back to results

Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors

Primary Purpose

Essential Tremor

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial ExAblate
Sponsored by
InSightec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Tremor

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • The Ohio State Wexner Medical Center
  • University of Pennsylvania
  • University of Virginia
  • Swedish Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial ExAblate

Arm Description

Transcranial ExAblate

Outcomes

Primary Outcome Measures

The incidence and severity of adverse events (AEs)

Secondary Outcome Measures

Effectiveness of the ExAblate Transcranial MRgFUS treatment of medication-refractory Essential Tremor (ET) will be determined using the Clinical Rating Scale for Tremor (CRST)

Full Information

First Posted
November 10, 2014
Last Updated
December 19, 2022
Sponsor
InSightec
search

1. Study Identification

Unique Protocol Identification Number
NCT02289560
Brief Title
Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
Official Title
A Continued Access 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
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2015 (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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial ExAblate
Arm Type
Experimental
Arm Description
Transcranial ExAblate
Intervention Type
Device
Intervention Name(s)
Transcranial ExAblate
Other Intervention Name(s)
ExAblate, TcMRgFUS, Thalamotomy
Intervention Description
Transcranial ExAblate
Primary Outcome Measure Information:
Title
The incidence and severity of adverse events (AEs)
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Effectiveness of the ExAblate Transcranial MRgFUS treatment of medication-refractory Essential Tremor (ET) will be determined using the Clinical Rating Scale for Tremor (CRST)
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
The Ohio State Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
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

12. IPD Sharing Statement

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

Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors

We'll reach out to this number within 24 hrs