A Feasibility Clinical Trial of the Management of the Medically Refractory Dyskinesia Symptoms of Advanced Idiopathic Parkinsons Disease With Unilateral Lesioning of the Globus Pallidum Using the ExAblate Transcranial System
- Conditions
- Medically Refractory Dyskinesia Symptoms of Advanced Idiopathic Parkinsons Disease
- Registration Number
- JPRN-UMIN000033955
- Lead Sponsor
- Medical Corporation Tokushukai Shonanfujisawa Tokushukai hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 10
Not provided
1.Hoehn and Yahr stage in the on medication state of 3 or greater 2.Presence of other central neurodegenerative disease suspected on neurological examination. 3.Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications. 4.Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia 5.Presence of significant cognitive impairment defined as score 21 Unstable psychiatric disease, 6.Subjects with significant depression as determined following a comprehensive assessment by a neuropsychologist. 7.Subjects exhibiting any behavior consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM 4 . 8.9.Subjects with unstable cardiac status including. 10.Severe hypertension 11.Current medical condition resulting in abnormal bleeding and or coagulopathy 12.Receiving anticoagulant 13.Subjects with risk factors for intraoperative or postoperative bleeding as indicated 14.Patient with severely impaired renal function with estimated glomerular filtration rate 15.Subjects with standard contraindications for MR imaging 16.Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment. 17.History of intracranial hemorrhage 18.History of multiple strokes, or a stroke within past 6 months 19.Subjects with a history of seizures within the past year 20.Subjects with brain tumors 21.Subjects with intracranial aneurysms requiring treatment or arterial venous malformations requiring treatment. 22.Pregnancy or lactation. 23.All patients with severe premorbid risks3 4 MDS UPDRS Part1 2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method