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ExAblate Transcranial MRgFUS of the Globus Pallidum for Treatment of Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02263885
Recruitment Status : Active, not recruiting
First Posted : October 13, 2014
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
InSightec

Brief Summary:
The proposed study will evaluate the safety, and initial efficacy of using the ExAblate Transcranial to create a unilateral lesion in the globus pallidus as an adjunct to PD medications in subjects who are over 30 years of age and considered medication-refractory with advanced idiopathic Parkinson's disease (PD).

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: ExAblate Transcranial System Not Applicable

Detailed Description:

The purpose of this study is to evaluate the safety and initial clinical effectiveness of ExAblate Transcranial unilateral thermal ablation of the globus pallidus of subjects suffering from medication-refractory, advanced idiopathic PD.

Data will be collected to establish the basic safety and clinical efficacy of this type of treatment as the basis for later studies that will evaluate the full clinical efficacy.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Clinical Trial of the Management of the Medically-Refractory Dyskinesia Symptoms of Advanced Idiopathic Parkinson's Disease With Unilateral Lesioning of the Globus Pallidum Using the ExAblate Transcranial System
Study Start Date : April 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Severity of Device and Procedure related complications [ Time Frame: At the time of Exablate transcranial procedure ]
    Safety will be determined by an evaluation of the incidence and severity of device- and procedure-related complications from the first treatment day visit through the 6 month post-treatment time point. All AEs will be reported and categorized by investigators as definitely, probably, possibly, unlikely, or unrelated to the device, pallidotomy procedure, and/or Parkinson's disease progression. Alternative treatments for PD subject tremor will also be captured should they occur. Adverse events will be reviewed by a Data Safety Monitoring Board at periodic intervals. Relative safety of the ExAblate Transcranial treatment will be evaluated as compared to other methodologies for creating pallidotomy as reported in the literature.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, age 30 years and older
  • Subjects who are able and willing to give informed consent and able to attend all study visits through 24 Months
  • Subjects with a diagnosis of idiopathic PD
  • Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor subscale in the ON vs OFF medication state.
  • Disabling motor complications of PD on optimum medical treatment
  • Predominant disability from one side of the body (i.e unilateral or markedly asymmetric disease) as determined by movement disorders neurologist and neurosurgeon
  • Subjects should be on a stable dose of all PD medications for 30 days prior to study entry.
  • Subject is able to communicate sensations during the ExAblate Transcranial procedure.

Exclusion Criteria:

  • Presence of other central neurodegenerative disease suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia with Lewy bodies, and Alzheimer's disease.
  • Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
  • Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
  • Unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation. Subjects with stable, chronic anxiety or depressive disorders may be included provided their medications have been stable for at least 60 days prior to study entry and if deemed appropriately managed by the site neuropsychologist
  • Subjects with significant depression as determined following a comprehensive assessment by a neuropsychologist.
  • Legal incapacity or limited legal capacity as determined by the neuropsychologist
  • Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
  • Subjects with unstable cardiac status including:

    1. Unstable angina pectoris on medication
    2. Subjects with documented myocardial infarction within six months of protocol entry
    3. Significant congestive heart failure defined with ejection fraction < 40
    4. Subjects with unstable ventricular arrhythmias
    5. Subjects with atrial arrhythmias that are not rate-controlled
  • Severe hypertension (diastolic BP > 100 on 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 (e.g. Avastin) within one month of focused ultrasound procedure
  • Subjects with risk factors for intraoperative or postoperative bleeding as indicated by: platelet count less than 100,000 per cubic millimeter, a documented clinical coagulopathy, or INR coagulation studies exceeding the institution's laboratory standard
  • Patient with severely impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2 (or per local standards should that be more restrictive) and/or who is on dialysis;
  • Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
  • Significant claustrophobia that cannot be managed with mild medication.
  • Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment.
  • History of intracranial hemorrhage
  • History of multiple strokes, or a stroke within past 6 months
  • Subjects with a history of seizures within the past year
  • Subjects with brain tumors
  • Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment.
  • Are participating or have participated in another clinical trial in the last 30 days
  • Any illness that in the investigator's opinion preclude participation in this study.
  • Subjects unable to communicate with the investigator and staff.
  • Pregnancy or lactation.

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): NCT02263885


Locations
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Maryland
University of Maryland Medical System
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Ohio
The Ohio State Wexner Medical Center
Columbus, Ohio, United States, 43210
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
InSightec

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT02263885     History of Changes
Other Study ID Numbers: PD002
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

Keywords provided by InSightec:
Parkinson's Disease
ExAblate
MRgFUS

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases