Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02252380
Recruitment Status : Recruiting
First Posted : September 30, 2014
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
InSightec

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Movement Disorders Essential Tremor Holmes Tremor Parkinson's Disease Wilson's Disease Huntington's Disease Dystonia Tardive Dyskinesia Orofacial Dyskinesias Device: Transcranial ExAblate System Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Clinical Trial of the Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for the Management of Treatment-Refractory Movement Disorders
Study Start Date : May 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Transcranial ExAblate System
Transcranial ExAblate System (MRgFUS)
 Device: Transcranial ExAblate System
MR Guided Focused Ultrasound
Other Names:
  • MRgFUS
  • Focused Ultrasound
  • FUS


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252380


Contacts
Layout table for location contacts
Contact: Maheleth Llinas 416-603-5800 ext 6121 Maheleth.Llinas@uhnresearch.ca

Locations
Layout table for location information
Canada, Ontario
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Nadia Scantlebury    416-480-6100 ext 4738    Nadia.Scantlebury@sunnybrook.ca   
Principal Investigator: Michael Schwartz, M.D.         
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Maheleth Llinas    416-603-5800 ext 6121    Maheleth.Llinas@uhnresearch.ca   
Principal Investigator: Andres Lozano, MD         
Sponsors and Collaborators
InSightec
Investigators
Layout table for investigator information
Principal Investigator: Andres Lozano, MD Sunnybrook Health Sciences Centre
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT02252380     History of Changes
Other Study ID Numbers: MD003
First Posted: September 30, 2014    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: March 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatolenticular Degeneration
Parkinson Disease
Dystonia
Tremor
Dyskinesias
Huntington Disease
Essential Tremor
Movement Disorders
Tardive Dyskinesia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
 Neurologic Manifestations
Signs and Symptoms
Dementia
Chorea
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Dyskinesia, Drug-Induced
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Metabolism, Inborn Errors