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

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ClinicalTrials.gov Identifier: NCT01772693
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
InSightec

Tracking Information
First Submitted Date  ICMJE November 28, 2012
First Posted Date  ICMJE January 21, 2013
Last Update Posted Date March 20, 2019
Actual Study Start Date  ICMJE September 2012
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01772693 on ClinicalTrials.gov Archive Site
Current 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current 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.
Original Other Pre-specified Outcome Measures Same as current
 
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 March 2019   (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
Responsible Party InSightec
Study Sponsor  ICMJE InSightec
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeff Elias, M.D. University of Virginia
PRS Account InSightec
Verification Date March 2019

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