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).
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Transcranial MRgFUS
Stanford University Medical Center
Stanford, California, United States
University of Maryland Medical System
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
The Ohio State Wexner Medical Center
Columbus, Ohio, United States
Adverse Events
The primary outcome of this feasibility trial was safety. Adverse Events were categorized by physicians as mild, moderate, or severe. Events resulting in impairment, requiring intervention to preclude impairment, or that were life threatening, and deaths were reported by physicians as Serious Adverse Events. Outcomes are entered in the adverse events module.
Time frame: Month 24
Unified Dyskinesia Rating Scale Total Score.
The Unified Dyskinesia Rating Scale Total score assesses overall involuntary movements associated with the treatment of Parkinson's disease. The minimum score possible is 0. The maximum total score possible is 104. High scores show worse symptoms.
Time frame: Screening, Month 3, Month 6, Month 12, Month 24
Unified Dyskinesia Rating Scale (UDysRS), Part III
The Unified Dyskinesia Ratient Scale (UDysRS) was developed to assess involuntary movements often associated with the treatment of Parkinson's disease. Part III evaluates the intensity of impairment of dyskinesia with respect to the performance of 7 tasks on a scale of 0 to 4. The sum of the Part III score ranges 0 to 28 and high scores show worse symptoms.
Time frame: Screening, Month 3, Month 6, Month 12, Month 24
Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III Motor Exam
The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS UPDRSP Part III motor exam focuses specifically on the treated side tremor and motor fluctuations. Each of 11 items are scored from 0 to 4 for a total score minimum of 0 and a maximum of 44 points. High scores show worse symptoms.
Time frame: Screening, Month 3, Month 6, Month 12, Month 24
Mood Disorders Society - Unified Parkinson's Disease Rating Scale Part II
.Part II of the Mood Disorders Society Unified Parkinson's Disease Rating Scale focuses on the impact of symptoms on motor aspects of daily living. Part II consists of 13 items scored from 0 to 4 for a maximum score of 52. High Part II scores indicate worse (greater) impact.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Virginia
Charlottesville, Virginia, United States
Time frame: Screening, Month 3, Month 6, Month 12, Month 24
Mood Disorder Society Unified Parkinson's Disease Rating Scale Part IV
Part IV of the Mood Disorder Society Unified Parkinson's Disease Rating Scale assesses dyskinesias that include OFF-state dystonia; items include time spent with dyskinesia, functional impact of dyskinesia, time spent in the OFF state, functional impact of fluctuations, complexity of motor fluctuations and painful OFF state dystonia. Six items are scored 0 to 4 with a maximum total score of 24. High scores indicate worse symptoms.
Time frame: Screening, Month 3, Month 6, Month 12, Month 24