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

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Brief Title

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

Official Title

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

Brief Summary

      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.
    

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


Primary Outcome

Severity of Device and Procedure Related Complications


Condition

Movement Disorders

Intervention

Transcranial ExAblate System

Study Arms / Comparison Groups

 Transcranial ExAblate System
Description:  Transcranial ExAblate System (MRgFUS)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

10

Start Date

May 2015

Completion Date

December 2021

Primary Completion Date

December 2021

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Andres Lozano, MD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02252380

Organization ID

MD003


Responsible Party

Sponsor

Study Sponsor

InSightec


Study Sponsor

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


Verification Date

January 2020