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Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors

Sponsor
InSightec (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02289560
Collaborator
(none)
50
Enrollment
7
Locations
1
Arm
92
Duration (Months)
7.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this prospective, multi site, single-arm study is to capture the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in patients with essential tremor (ET).

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial ExAblate
 N/A

Detailed Description

This study is evaluating a new technique for performing Thalamotomy for tremor control. While current techniques have possible invasive or radiation effects, the use of ExAblate if totally non-invasive and without any radiation. After informed consent and screening, eligible subjects will be undergo an ExAblate treatment. All subjects will be followed at 1 day, 1 week, 1, 3, 6 and 12 months and for up to 5 years as directed by their doctor.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Continued Access Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
Study Start Date :
Apr 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Transcranial ExAblate

Transcranial ExAblate

Device: Transcranial ExAblate
Transcranial ExAblate
Other Names:
  • ExAblate
  • TcMRgFUS
  • Thalamotomy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The incidence and severity of adverse events (AEs) [intraoperative]

    Secondary Outcome Measures

    1. Effectiveness of the ExAblate Transcranial MRgFUS treatment of medication-refractory Essential Tremor (ET) will be determined using the Clinical Rating Scale for Tremor (CRST) [participants will be followed from the date of treatment until study completion, approximately up to 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Men and women, age 22 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 Essential Tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder

    • Subject exhibits a significant disability from their ET despite medical treatment

    • Subjects should be on a stable dose of all ET 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

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Medical Center Stanford California United States 94305
    2 University of Maryland Medical System Baltimore Maryland United States 21201
    3 Brigham and Women's Hospital Boston Massachusetts United States 02115
    4 The Ohio State Wexner Medical Center Columbus Ohio United States 43210
    5 University of Pennsylvania Philadelphia Pennsylvania United States 19106
    6 University of Virginia Charlottesville Virginia United States 22908
    7 Swedish Medical Center Seattle Washington United States 98122

    Sponsors and Collaborators

    • InSightec

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    InSightec
    ClinicalTrials.gov Identifier:
    NCT02289560
    Other Study ID Numbers:
    • ET002CA
    First Posted:
    Nov 13, 2014
    Last Update Posted:
    Sep 8, 2021
    Last Verified:
    Aug 1, 2021
    Additional relevant MeSH terms:
    Tremor
    Essential Tremor

    Study Results

    No Results Posted as of Sep 8, 2021