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Trial record 1 of 1 for:    03465761
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Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor

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ClinicalTrials.gov Identifier: NCT03465761
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
InSightec

Tracking Information
First Submitted Date  ICMJE March 8, 2018
First Posted Date  ICMJE March 14, 2018
Last Update Posted Date September 8, 2021
Actual Study Start Date  ICMJE January 3, 2019
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2018)
  • Clinical Rating Scale for Tremor (CRST) [ Time Frame: Baseline through Month 12 after First and Second Treatment ]
    The CRST is a standard tremor rating scale which measures subjects' tremor (Part A), motor Function (Part B), and Activities of Daily Living (Part C). Scores range from 0-4 with 0 being no tremor.
  • Incidence of Device and Procedure related Adverse Events [ Time Frame: Treatment through Month 12 after Second Treatment ]
    All AEs will be reported and categorized by investigators in relation to the device or procedure, disease or unrelated to the device or procedures and categorized by first or second Exablate thalamotomy.
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
  • Clinical Rating Scale for Tremor (CRST) [ Time Frame: Baseline through Month 12 after First and Second Treatment ]
    The CRST is a validated, tremor rating scale which measures subjects' tremor (Part A), motor Function (Part B), and Activities of Daily Living (Part C).
  • Incidence of Device and Procedure related Adverse Events [ Time Frame: Treatment through Month 12 after First and Second Treatment ]
    All AEs will be reported and categorized by investigators in relation to the treatment assignment, device or procedure, disease or unrelated to the device or procedures and categorized by first or second Exablate thalamotomy.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
Official Title  ICMJE A Clinical Trial to Evaluate the Safety and Efficacy of Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
Brief Summary

The objective of this prospective, multi-site, single-arm, open-label study is to capture the safety and efficacy (outcome) of bilateral staged Exablate treatment in subjects with bilateral medication-refractory essential tremor (ET). The staged second procedure will be performed at least 9 months after the first side. The benefit of real-time feedback will allow the physician to maximize benefit without jeopardizing safety.

This study is designed as a prospective, open-label, single arm, multi-site study design.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Essential Tremor
Intervention  ICMJE Device: ExAblate
Bilateral side treatment of Essential Tremor
Study Arms  ICMJE Experimental: ExAblate 4000 System
ExAblate treatment of Bilateral Essential Tremor
Intervention: Device: ExAblate
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 13, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2022
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects who:

    1. previously underwent Exablate thalamotomy for their essential tremor in a clinical study or in a commercial procedure at least 9 months prior to enrolling in this study for contralateral Exablate thalamotomy
    2. Subjects who would benefit from a bilateral treatment for their essential tremor and would want to undergo a staged bilateral thalamotomy
  2. All subjects must have a complete baseline CRST prior from first Exablate thalamotomy
  3. Men and women age 22 years to 75 years of age.
  4. Minimum score of 24 on MoCA or 20 on MMSE
  5. Subjects who are able and willing to give consent and able to attend all study visits
  6. Postural or intention tremor severity score of greater than or equal to 2 in the both upper extremities as measured by the CRST rating scale while on stable medication
  7. Thalamus can be targeted by the Exablate device. The region must be apparent on MRI such that targeting can be performed.
  8. Able to communicate sensations during the Exablate Thalamotomy treatment
  9. Original (before first Exablate procedure) CRST score of 2 or above in any one of the items 16-23 from the Disability subsection of the CRST: speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities.
  10. Subjects on antidepressant medications must be stable for at least 3 months prior to procedure(i.e., no change in medication drug or dosage for 3 months based on historical medical records).
  11. Remains eligible for Exablate treatment with no changes to medical history that would affect Exablate treatment criteria, (e.g., bleeding/coagulation requirements, or new pathology such as infarct, tumor, etc).

Exclusion Criteria:

  1. Subjects with unstable cardiac status
  2. Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within a 12 month period:
  3. Subjects with uncontrollable blood pressure (hypertensive with diastolic BP > 100 on medication)
  4. History of abnormal bleeding and/or coagulopathy, i.e. subjects with risk factors for intraoperative or postoperative bleeding as indicated by: platelet count less than 100,000 per cubic millimeter, a documented clinical coagulopathy, or INR coagulation studies exceeding the institution's laboratory standard
  5. 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 (e.g. Avastin) within one month of focused ultrasound procedure
  6. Active or suspected acute or chronic uncontrolled infection
  7. 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.)
  8. Subjects with life-threatening systemic disease that include but not limited to the following will be excluded from the study participation: HIV, Liver Failure, blood dyscrasias, etc...
  9. Any clinically significant moderate to severe sensory deficit lasting greater than 30 days after the first Exablate thalamotomy NOTE: Subjects with clinically significant moderate to severe sensory deficit following first Exablate thalamatomy should be excluded even if event resolves within a few months of treatment. This may cause new first thalamotomy subjects to be ineligible for the bilaterally staged treatment.
  10. Moderate to severe cerebellar disturbance (imbalance or ataxia) or presence of moderate or severe hemiparesis NOTE: Subjects with moderate to severe cerebellar disturbance (imbalance or ataxia) or presence of moderate or severe hemiparesis following first Exablate thalamatomy should be excluded even if event resolves within a few months of treatment. This may cause new first thalamotomy subjects to be ineligible for the bilaterally staged treatment.
  11. Any persistent dysphasia/dysarthria, language impairment following first Exablate thalamotomy.

    NOTE: Subjects with significant impairment following first Exablate thalamotomy should be excluded even if event resolves within a few months of treatment. This may cause new first thalamotomy subjects to be ineligible for the bilaterally staged treatment.

  12. Significant reduction in cognitive function since the first thalamotomy. NOTE: Subjects with significant reduction in cognitive function following first Exablate thalamatomy should also be excluded even if event resolves within a few months of treatment. This may cause new first thalamotomy subjects to be not eligible for the bilaterally staged treatment.
  13. Subject is pregnant or breastfeeding.
  14. Subjects who have an overall Skull Density Ratio of less than 0.40 as calculated at screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: khaja Rehman 214-630-2000 khajar@insightec.com
Listed Location Countries  ICMJE Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03465761
Other Study ID Numbers  ICMJE ET003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InSightec
Study Sponsor  ICMJE InSightec
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account InSightec
Verification Date August 2021

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