Medically Refractory Dyskinesia Symptoms of Advanced Idiopathic Parkinsons Disease
Conditions
Interventions
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 and considered
Sponsors
Medical Corporation Tokushukai Shonanfujisawa Tokushukai hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women, age 20 years and older 2. Subjects who are able and willing to give informed consent and able to attend all study visits through 24 Months 3. Subjects with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site 4. Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor subscale in the ON vs OFF medication state. 5. MDS UPDRS score of 30 in the meds OFF condition 6. Disabling motor complications of PD on optimum medical treatment characterized dyskinesia or motor fluctuations (MDS-UPDRS item 4.2 score of 2 or 3 in the meds ON condition) 7. Predominant disability from one side of the body. 8. Subjects should be on a stable dose of all PD medications for 30 days prior to study entry. 9. Subject is able to communicate sensations during the ExAblate Neuro procedure.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactEtsuko Shimizu
Medical Corporation Tokushukai Shonanfujisawa Tokushukai hospital Clinical Research Center
Outcome results
None listed