A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease

Last updated: April 29, 2025
Sponsor: InSightec
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dystonia

Treatment

Unilateral thalamotomy

Clinical Study ID

NCT04991831
PD012
  • Ages 30-99
  • All Genders

Study Summary

The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Men and women, age 30 years and older

  2. Subject undergoing an Exablate procedure for their planned TDPD treatment; per localinstitution standard of care.

  3. Subject is willing to cooperate with the Registry requirements including compliancewith the regimen and completion of all study visits

  4. Subject has signed and received a copy of the approved informed consent form

Exclusion

Exclusion Criteria:

Subject does not agree to participate or is unlikely to participate for the entirety of the study.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Unilateral thalamotomy
Phase:
Study Start date:
April 28, 2022
Estimated Completion Date:
December 31, 2027

Study Description

This is a post-approval registry which is required by of the approval under PMA P150038/S006 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral thalamotomy in the treatment of medication refractory Tremor Dominant Parkinson's Disease (TDPD). Subjects participating in this registry will have received a unilateral thalamotomy (ventralis medius) prior to enrollment using the commercially available Exablate Neuro for the treatment of Essential tremor and TDPD.

The following assessments will be collected at Baseline,1, 3, 6, and 12 months post Exablate procedure and annually thereafter for 5 years:

  • Adverse Events (AEs) (does not apply to Baseline Visit)

  • Medication usage

  • Clinical Rating Scale for Tremor (CRST) ON medication

  • Unified Parkinson's Disease Rating Scale Part III ON medication

  • EQ-5D-5L

  • WPAI-GH

Connect with a study center

  • University of Dundee

    Dundee, Scotland DD1 9SY
    United Kingdom

    Active - Recruiting

  • Miami Neuroscience Institute Baptist Health

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Rush University

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Weill Cornell Medicine

    New York, New York 10065
    United States

    Active - Recruiting

  • Novant Health Brain & Spine Surgery

    Huntsville, North Carolina 28708
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Miami Valley Hospital

    Fairborn, Ohio 45324
    United States

    Active - Recruiting

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