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ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease

Primary Purpose

Parkinson's Disease

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

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring ExAblate Transcranial MRgFUS

Eligibility Criteria

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

Inclusion Criteria:

  • Men and women, age 30 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 idiopathic PD as confirmed from clinical history and examination by a movement disorder neurologist at the site
  • Subject demonstrates a severe resting tremor or postural/action as measured by UPDRS
  • Subject exhibits a significant disability from their PD tremor despite medical treatment
  • Subjects should be on a stable dose of all PD 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
  • Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
  • 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
  • Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment
  • Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia

Sites / Locations

  • University of Virginia
  • Swedish Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

ExAblate Transcranial MRgFUS

Sham ExAblate Transcranial MRgFUS

Arm Description

ExAblate Transcranial MR guided Focused Ultrasound

Sham treatment with ExAblate MR guided Focused Ultrasound

Outcomes

Primary Outcome Measures

Number of Adverse Events
Evaluate of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory, tremor-dominant PD during the ExAblate treatment. Primary safety analyses are reported in the adverse events module.

Secondary Outcome Measures

Tremor Motor Score 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).
Tremor Motor Scores - Clinical Rating Scale for Tremor - Treated Side Upper Extremity Parts A & B.
Upper extremity Tremor-Motor score for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that measures treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points for each side with lower scores being a better outcome. Subject's Tremor-Motor scores for the test and sham control groups were averaged at each study visit.
Functional Disabilities - Clinical Rating Scale for Tremor Part C - Functional Disabilities
The Clinical Rating Scale for Tremor (CRST) Part C is a measure of functional disability due to tremor. The Clinical Rating Scale for Tremor Part C consists of 8 items each scored from 0 to 4. Thus, the total score summed ranges from 0 to 32 and provides an overall assessment of activities of daily living. Low scores on the Clinical Rating Scale for Tremor (CRST) Part C are better. Low scores show improvement in functional disabilities compared to higher scores.

Full Information

First Posted
November 28, 2012
Last Updated
September 17, 2020
Sponsor
InSightec
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1. Study Identification

Unique Protocol Identification Number
NCT01772693
Brief Title
ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease
Official Title
A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 2012 (Actual)
Primary Completion Date
April 26, 2016 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a feasibility study to evaluate the safety and initial effectiveness of unilateral ExAblate thermal ablation of the Vim thalamic nucleus of subjects suffering from medication-refractory, idiopathic, tremor-dominant PD, using the ExAblate Transcranial system compared to a Sham Vim thalamotomy procedure. Data will be collected to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy. The Sham treatment data will be used to evaluate placebo effect from treatment.
Detailed Description
Subjects who sign informed consent and pass all eligibility criteria will be randomized to a treatment assignment. During treatment, the assigned treatment (ExAblate Transcranial or Sham ExAblate Transcranial)will be delivered. Subjects are followed in a blinded fashion for three (3) months. After the 3-month assessment, subjects will be unblinded and told their treatment assignment. Subjects receiving Sham ExAblate Transcranial treatment who still meet criteria will be crossed over and receive an active ExAblate Transcranial treatment. Subjects will be followed for up to two (2) years. Follow-up at 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and up to two (2) years includes Unified Parkinson's Disease Rating Scale (UPDRS) scoring, mental and cognitive functional testing and questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
ExAblate Transcranial MRgFUS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single factor. ExAblate test verses ExAblate placebo randomized 2:1.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ExAblate Transcranial MRgFUS
Arm Type
Experimental
Arm Description
ExAblate Transcranial MR guided Focused Ultrasound
Arm Title
Sham ExAblate Transcranial MRgFUS
Arm Type
Sham Comparator
Arm Description
Sham treatment with ExAblate MR guided Focused Ultrasound
Intervention Type
Device
Intervention Name(s)
ExAblate Transcranial MRgFUS
Other Intervention Name(s)
ExAblate, MRgFUS, Focused Ultrasound, Transcranial MRgFUS Thalamotomy
Intervention Description
ExAblate Transcranial MR Guided Focused Ultrasound
Intervention Type
Device
Intervention Name(s)
Sham ExAblate Transcranial MRgFUS
Intervention Description
Sham ExAblate Transcranial MR Guided Focused Ultrasound
Primary Outcome Measure Information:
Title
Number of Adverse Events
Description
Evaluate of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory, tremor-dominant PD during the ExAblate treatment. Primary safety analyses are reported in the adverse events module.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Tremor Motor Score Percent Change From Baseline.
Description
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).
Time Frame
Baseline, Month 3
Title
Tremor Motor Scores - Clinical Rating Scale for Tremor - Treated Side Upper Extremity Parts A & B.
Description
Upper extremity Tremor-Motor score for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that measures treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points for each side with lower scores being a better outcome. Subject's Tremor-Motor scores for the test and sham control groups were averaged at each study visit.
Time Frame
Baseline, Month 3, Month 12
Title
Functional Disabilities - Clinical Rating Scale for Tremor Part C - Functional Disabilities
Description
The Clinical Rating Scale for Tremor (CRST) Part C is a measure of functional disability due to tremor. The Clinical Rating Scale for Tremor Part C consists of 8 items each scored from 0 to 4. Thus, the total score summed ranges from 0 to 32 and provides an overall assessment of activities of daily living. Low scores on the Clinical Rating Scale for Tremor (CRST) Part C are better. Low scores show improvement in functional disabilities compared to higher scores.
Time Frame
Baseline, Month 3, Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women, age 30 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 idiopathic PD as confirmed from clinical history and examination by a movement disorder neurologist at the site Subject demonstrates a severe resting tremor or postural/action as measured by UPDRS Subject exhibits a significant disability from their PD tremor despite medical treatment Subjects should be on a stable dose of all PD 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 Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse 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 Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Elias, M.D.
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
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

Citations:
PubMed Identifier
29084313
Citation
Bond AE, Shah BB, Huss DS, Dallapiazza RF, Warren A, Harrison MB, Sperling SA, Wang XQ, Gwinn R, Witt J, Ro S, Elias WJ. Safety and Efficacy of Focused Ultrasound Thalamotomy for Patients With Medication-Refractory, Tremor-Dominant Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2017 Dec 1;74(12):1412-1418. doi: 10.1001/jamaneurol.2017.3098.
Results Reference
derived

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ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease

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