ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders

April 30, 2025 updated by: InSightec

A Feasibility Clinical Trial of the Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for the Management of Treatment-Refractory Movement Disorders

The proposed study is to evaluate the effectiveness of ExAblate Transcranial MRgFUS as a tool for creating a unilateral lesion in the Vim thalamus or the globus pallidus (GPi) in patients with treatment-refractory symptoms of movement disorders.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided focused ultrasound thermal ablation of a designated area in the brain of patients suffering from movement disorder symptoms:

  • FUS under MRI-guidance and MRI-based thermometry can be safely delivered to patients suffering from treatment-refractory movement disorders through an intact human skull with a low risk of transient adverse effects as evaluated during follow-up of up to 12-months.
  • A pre-defined target volume inside the brain can be accurately ablated, as demonstrated on post-treatment MRI.
  • Lesions generated with ExAblate Neuro will result in clinical effects that are similar to those seen with ablative procedures using other surgical techniques (e.g. RF procedure).

Study Type

Interventional

Enrollment (Estimated)

10

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 Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital

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

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men and women, between 18 and 85 years, inclusive.
  • Subjects who are able and willing to give consent and able to attend all study visits.

  • A movement disorder symptom that has been deemed treatment-refractory by a movement disorder neurologist, including:

    o akathisia, akinesia, athetosis, bradykinesia, chorea, dystonia, tremor, myoclonus, dyskinesia, spasms, tics

  • Medication-refractoriness as determined by an adequate dose and duration of standard movement disorders treatment as determined by a specialist neurologist (e.g. a trial of primidone and propranolol for ET)
  • Able to communicate sensations during the ExAblate Neuro treatment
  • Stable doses of all medications for 30 days prior to study entry and for the duration of the study.

Exclusion Criteria:

  • Patients with unstable cardiac status including:

    • Unstable angina pectoris on medication
    • Patients with documented myocardial infarction within six months of protocol entry
    • Congestive heart failure requiring medication (other than diuretic)
    • Patients on anti-arrhythmic drugs
  • Severe hypertension (diastolic BP > 100 on medication)
  • Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
  • History of abnormal bleeding and/or coagulopathy (including deep venous thrombosis)
  • Cerebrovascular disease (multiple CVA or CVA within 6 months)
  • Symptoms and signs of increased intracranial pressure (e.g. headache, nausea, vomiting, lethargy, and papilledema)
  • Untreated, uncontrolled sleep apnea
  • Active or suspected acute or chronic uncontrolled infection
  • History of intracranial hemorrhage
  • Individuals 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
  • Patients unable to communicate with the investigator and staff.
  • Presence of any other neurodegenerative disease like multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
  • Patients with a history of seizures within the past year
  • Patients with psychiatric illness that are not well controlled. Any presence of psychosis will be excluded.
  • Patients with risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter) or a documented coagulopathy
  • Patients with brain tumors
  • Any illness that in the investigator's opinion preclude participation in this study.
  • Pregnancy or lactation.
  • Patient is unable to provide his own consent for any reason.
  • Legal incapacity or limited legal capacity.
  • Patients who have DBS or a prior stereotactic ablation of the basal ganglia
  • History of immunocompromise, including patient who is HIV positive
  • Known life-threatening systemic disease

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: Transcranial ExAblate System
Transcranial ExAblate System (MRgFUS)
Device: Transcranial ExAblate System
MR Guided Focused Ultrasound
Other Names:
  • Focused Ultrasound
  • MRgFUS
  • FUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of Device and Procedure Related Complications
Time Frame: At the time of ExAblate procedure
Safety will be evaluated individually for each subject who is treated
At the time of ExAblate procedure

Collaborators and Investigators

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

Sponsor

InSightec

Investigators

  • Principal Investigator: Andres Lozano, MD, Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2015

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

September 29, 2014

First Posted (Estimated)

September 30, 2014

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD003

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.

Clinical Trials on Parkinson's Disease

Clinical Trials on Transcranial ExAblate System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe