Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor

December 19, 2022 updated by: InSightec

A Clinical Trial to Evaluate the Safety and Efficacy of Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ExAblate 4000 System
ExAblate treatment of Bilateral Essential Tremor
Device: ExAblate
Bilateral side treatment of Essential Tremor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline through Month 12 after First and Second Treatment
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.
Treatment through Month 12 after Second Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InSightec

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2019

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

March 8, 2018

First Submitted That Met QC Criteria

March 13, 2018

First Posted (Actual)

March 14, 2018

Study Record Updates

Last Update Posted (Actual)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 19, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ET003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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