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A Study to Evaluate the Effectiveness and Safety of ExAblate MRgFUS on Essential Tremor

Primary Purpose

Essential Tremor

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MRgFUS treatment
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 - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Men and women age 22 years or older
  • A diagnosis of ET as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder
  • Have had an inadequate response to one or two oral doses of medication, per local standards. An inadequate medication trial is defined as a therapeutic dose of each medication and poor response to drug, or the development of side effects as the medication dose is titrated.
  • Able to communicate sensations during the ExAblate TcMRgFUS treatment

Exclusion criteria:

  • Subjects with unstable cardiac status
  • Severe hypertension (diastolic BP > 100 on medication)
  • 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 (e.g. Gadolinium or Magnevist) including advanced kidney disease
  • Patient with severely impaired renal function
  • History of abnormal bleeding and/or coagulopathy
  • History of immunocompromise including those who are HIV positive.
  • History of intracranial hemorrhage
  • Cerebrovascular disease (multiple CVA or CVA within 6 months)
  • Subjects with uncontrolled symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, papilledema).
  • Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time.)
  • Are participating or have participated in another clinical trial in the last 30 days
  • Significant claustrophobia that cannot be managed with mild medication.
  • Presence of any other neurodegenerative disease such as Parkinson-plus syndromes suspected on neurological examination.
  • Presence of significant cognitive impairment
  • Subjects with life-threatening systemic disease
  • Subjects with a history of seizures within the past year
  • Subjects with presence or history of psychosis

Sites / Locations

  • Chinese PLA General Hospital
  • Henan Provincial People's Hospital
  • Sadamoto Hospital
  • Shonan Fujisawa Tokushukai Hospital
  • Hokkaido Ohno Memorial Hospital
  • Hokuto
  • Ohanishi Noerological Center
  • Kumagaya General Hospital
  • Department of Neurosurgery, Osaka University Hospital
  • Tokyo Women's Medical University Hospital
  • Chang Bing Show Chwan Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRgFUS treatment

Arm Description

MRgFUS device treatment, thalamotomy

Outcomes

Primary Outcome Measures

Safety - Will be determined evaluating incidence and severity of device related complications from first treatment day visit through all follow ups. Relative Safety will be evaluated describing Significant Clinical Complications for patients treated.
All AEs will be reported and categorized by investigators as definitely, probably, possibly, or unrelated to the device or procedure and categorized by treatment group / treatment arm. Relative Safety will be evaluated using a common description of Significant Clinical Complications for patients treated in this study.
Effectiveness - Will be evaluated using the Clinical Rating Scale for Tremors (CRST) for ET subjects. Comparison will be performed from examinations at baseline and 3-Months post-ExAblate treatment.
Assessments of efficacy endpoints will compare the three months after ExAblate treatment to Baseline measurements for clinical symptom relief.

Secondary Outcome Measures

Full Information

First Posted
July 24, 2017
Last Updated
April 19, 2023
Sponsor
InSightec
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1. Study Identification

Unique Protocol Identification Number
NCT03253991
Brief Title
A Study to Evaluate the Effectiveness and Safety of ExAblate MRgFUS on Essential Tremor
Official Title
A 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
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
November 17, 2014 (Actual)
Primary Completion Date
February 2, 2023 (Actual)
Study Completion Date
February 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InSightec

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects The objective of this prospective, single-arm study is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor inpatients with essential tremor (ET). The Indications for Use claim for this system is as follows: Treatment of medication-refractory tremor in patients with essential tremor.
Detailed Description
The objective of this prospective, multi-site, single-arm study 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). Safety: To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial MRgFUS treatment of medication-refractory ET Effectiveness: To determine the effectiveness of the ExAblate Transcranial MRgFUS treatment of medication-refractory tremor (i.e. ET). Efficacy will be determined utilizing the Clinical Rating Scale for Tremor (CRST) in ET from examinations at baseline and 3-Months post-ExAblate treatment. • This study is designed as a prospective, multi-site, single-arm study. Assessments of primary efficacy endpoints will compare the three months after ExAblate treatment to Baseline measurements for clinical symptom relief. Safety of ExAblate in the treatment of ET will be collected for one year after ExAblate treatment. Relative Safety will be evaluated using a common description of Significant Clinical Complications for patients treated in this study. This study will be performed on the 3T MR scanners. The secondary endpoints of the study are as follows: Quality life claims: Questionnaire for Essential Tremor (QUEST) outcome (upper extremity questions) at Months 3 change from Baseline 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 Subject daily functionalities: as measured by CRST Part-C (subscales)Month 12 as compared to Baseline.

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
Model Description
Prospective multi-site, single-arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRgFUS treatment
Arm Type
Experimental
Arm Description
MRgFUS device treatment, thalamotomy
Intervention Type
Device
Intervention Name(s)
MRgFUS treatment
Other Intervention Name(s)
Thalamotomy
Intervention Description
ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
Primary Outcome Measure Information:
Title
Safety - Will be determined evaluating incidence and severity of device related complications from first treatment day visit through all follow ups. Relative Safety will be evaluated describing Significant Clinical Complications for patients treated.
Description
All AEs will be reported and categorized by investigators as definitely, probably, possibly, or unrelated to the device or procedure and categorized by treatment group / treatment arm. Relative Safety will be evaluated using a common description of Significant Clinical Complications for patients treated in this study.
Time Frame
1 year
Title
Effectiveness - Will be evaluated using the Clinical Rating Scale for Tremors (CRST) for ET subjects. Comparison will be performed from examinations at baseline and 3-Months post-ExAblate treatment.
Description
Assessments of efficacy endpoints will compare the three months after ExAblate treatment to Baseline measurements for clinical symptom relief.
Time Frame
5 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Men and women age 22 years or older A diagnosis of ET as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder Have had an inadequate response to one or two oral doses of medication, per local standards. An inadequate medication trial is defined as a therapeutic dose of each medication and poor response to drug, or the development of side effects as the medication dose is titrated. Able to communicate sensations during the ExAblate TcMRgFUS treatment Exclusion criteria: Subjects with unstable cardiac status Severe hypertension (diastolic BP > 100 on medication) 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 (e.g. Gadolinium or Magnevist) including advanced kidney disease Patient with severely impaired renal function History of abnormal bleeding and/or coagulopathy History of immunocompromise including those who are HIV positive. History of intracranial hemorrhage Cerebrovascular disease (multiple CVA or CVA within 6 months) Subjects with uncontrolled symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, papilledema). Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time.) Are participating or have participated in another clinical trial in the last 30 days Significant claustrophobia that cannot be managed with mild medication. Presence of any other neurodegenerative disease such as Parkinson-plus syndromes suspected on neurological examination. Presence of significant cognitive impairment Subjects with life-threatening systemic disease Subjects with a history of seizures within the past year Subjects with presence or history of psychosis
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
Sadamoto Hospital
City
Ehime
ZIP/Postal Code
790-0052
Country
Japan
Facility Name
Shonan Fujisawa Tokushukai Hospital
City
Fujisawa
ZIP/Postal Code
2510041
Country
Japan
Facility Name
Hokkaido Ohno Memorial Hospital
City
Hokkaido
ZIP/Postal Code
063-0052
Country
Japan
Facility Name
Hokuto
City
Hokkaido
ZIP/Postal Code
080-0833
Country
Japan
Facility Name
Ohanishi Noerological Center
City
Hyōgo
ZIP/Postal Code
6740064
Country
Japan
Facility Name
Kumagaya General Hospital
City
Kumagaya
ZIP/Postal Code
360-8567
Country
Japan
Facility Name
Department of Neurosurgery, Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Tokyo
ZIP/Postal Code
62-8666
Country
Japan
Facility Name
Chang Bing Show Chwan Memorial Hospital
City
Chang Hua
ZIP/Postal Code
505
Country
Taiwan

12. IPD Sharing Statement

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A Study to Evaluate the Effectiveness and Safety of ExAblate MRgFUS on Essential Tremor

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