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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01772693
Recruitment Status : Completed
First Posted : January 21, 2013
Results First Posted : October 9, 2020
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
InSightec

Tracking Information
First Submitted Date  ICMJE November 28, 2012
First Posted Date  ICMJE January 21, 2013
Results First Submitted Date  ICMJE July 23, 2020
Results First Posted Date  ICMJE October 9, 2020
Last Update Posted Date October 9, 2020
Actual Study Start Date  ICMJE September 2012
Actual Primary Completion Date April 26, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2020)
Number of Adverse Events [ Time Frame: Month 3 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 18, 2013)
Severity of Device and Procedure related complications [ Time Frame: At the time of the ExAblate Transcranial thalamotomy procedure ]
To evaluate the incidence and severity of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory, tremor-dominant PD during the ExAblate treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2020)
  • Tremor Motor Score Percent Change From Baseline. [ Time Frame: Baseline, Month 3 ]
    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. [ Time Frame: Baseline, Month 3, Month 12 ]
    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 [ Time Frame: Baseline, Month 3, Month 12 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2013)
UPDRS - Unified Parkinson's Disease Rating Scale [ Time Frame: up to 3 months ]
To evaluate the UPDRS score up to 3 months after ExAblate treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: January 18, 2013)
  • Severity of Device and Procedure related complications [ Time Frame: up to 2 years ]
    To evaluate the incidence and severity of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory, tremor dominant PD after the ExAblate treatment and during the follow-up period of up to 2 years.
  • Incidence of Device and Procedure related complications [ Time Frame: up to 2 years ]
    To evaluate the incidence and severity of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory, tremor dominant PD after the ExAblate treatment and during the follow-up period of up to 2 years.
  • Incidence of Device and Procedure related complications [ Time Frame: At the time of the ExAblate Transcranial thalamotomy procedure ]
    To evaluate the incidence and severity of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory, tremor dominant PD after the ExAblate treatment and during the follow-up period of up to 2 years.
 
Descriptive Information
Brief Title  ICMJE ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Single factor. ExAblate test verses ExAblate placebo randomized 2:1.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Device: ExAblate Transcranial MRgFUS
    ExAblate Transcranial MR Guided Focused Ultrasound
    Other Names:
    • ExAblate
    • MRgFUS
    • Focused Ultrasound
    • Transcranial MRgFUS Thalamotomy
  • Device: Sham ExAblate Transcranial MRgFUS
    Sham ExAblate Transcranial MR Guided Focused Ultrasound
Study Arms  ICMJE
  • Experimental: ExAblate Transcranial MRgFUS
    ExAblate Transcranial MR guided Focused Ultrasound
    Intervention: Device: ExAblate Transcranial MRgFUS
  • Sham Comparator: Sham ExAblate Transcranial MRgFUS
    Sham treatment with ExAblate MR guided Focused Ultrasound
    Intervention: Device: Sham ExAblate Transcranial MRgFUS
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2016)
27
Original Estimated Enrollment  ICMJE
 (submitted: January 18, 2013)
30
Actual Study Completion Date  ICMJE March 2019
Actual Primary Completion Date April 26, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01772693
Other Study ID Numbers  ICMJE PD001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party InSightec
Original Responsible Party Same as current
Current Study Sponsor  ICMJE InSightec
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeff Elias, M.D. University of Virginia
PRS Account InSightec
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP