A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Pallidotomy in the Treatment of Dyskinesia of Parkinson's Disease
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Levodopa Induced Dyskinesia in Patients With Parkinson's Disease
- Sponsor
- Yonsei University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- the unified dyskinesia rating scale (UdysRS) and UPDRS part IV
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The proposed study is to evaluate the safety and initial effectiveness of the ExAblate Transcranial MRI-guided focused ultrasound (MRgFUS) treatment of patients with dyskinesia of Parkinson's Disease (PD)
- Safety: To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial MRgFUS treatment of dyskinesia of PD
- Effectiveness: To determine the level of effectiveness of the ExAblate Transcranial MRgFUS treatment of dyskinesia of PD.Efficacy will be determined utilizing the UPDRS-IV for dyskinesia in PD from examinations at baseline and every 3-Months post-ExAblate treatment.
This study is designed as a prospective, single-site, single arm, nonrandomized study. Assessments will be made before and three months after MRgFUS for clinical symptom relief, quality of life (QoL) improvements, and safety of MRgFUS in the treatment of LID. Relative Safety will be evaluated using a common description of Significant Clinical Complications for patients treated in this study. This study will be performed on the 3T MR scanners.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women, between 20 and 80 years, inclusive
- •Willing to give consent and able to attend all study visits
- •Diagnosis of PD as confirmed from clinical history and examination by a movement disorder neurologist
- •Show unequivocal response to dopaminergic agents, specified as at least 33% improvement in United Parkinson Disease Rating Scale motor subscore (UPDRS-III) and diagnosed as idiopathic PD for more than 5 years.
- •GPi nucleus of pallidum can be targeted by the ExAblate device. The GPi region of the pallidum must be apparent on MRI such that targeting can be performed with either direct visualization or by measurement from a line connecting the anterior and posterior commissures of the brain.
- •Able to communicate sensations during the ExAblate MRgFUS treatment
- •One of dyskinesia rating scores greater than or equal to 2 in UPDRS-IV A-32, 33, \&
- •Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
- •Inclusion and exclusion criteria have been agreed upon by two members of the medical team.
Exclusion Criteria
- •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
- •Exhibit any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within a 12 month period: Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household). / Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use) / Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct) / Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights).
- •Severe hypertension (diastolic BP \> 100 on medication)
- •Contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- •Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
- •Severely impaired renal function (estimated glomerular filtration rate \< 45ml/min/1.73 m2) or receiving dialysis
- •History of 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
- •Active or suspected acute or chronic uncontrolled infection
- •History of intracranial hemorrhage
Outcomes
Primary Outcomes
the unified dyskinesia rating scale (UdysRS) and UPDRS part IV
Time Frame: 3 months after treatment
Dyskinesia will be assessed for each treated PD patient using the UDysRS and UPDRS part IV at baseline before treatment and at post-treatment intervals: 1 week, 1 month, and 3 months, 6 months and 12 months. The validated rating assessment of dyskinesia will be administered by a movement disorder neurologist or physical therapy specialist in an outpatient clinic setting. The primary measure utilized in this protocol will be a reduction in the contralateral upper extremity. Additionally, a total/overall dyskinesia score will be obtained for each patient at each time interval by summing the appendicular and axial scores.