Medication-Refractory Tremor Dominant Idiopathic Parkinson’s Disease
Conditions
Interventions
Single Arm:MR guided focused Ultrasound treating VIM
Sponsors
Henan Provincial People’s Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 100 Years
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 entire follow up period. 3. Subjects with a diagnosis of idiopathic PD as confirmed from clinical history and examination by a movement disorder neurologist or neurosurgeon at the site 4. All subjects included in this study will have a TD/PIGD ratio > 1.5 in the medicated [ON] state as calculated from the UPDRS formula as described by S, et. al., [74]. 5. Subject demonstrates a resting tremor severity score of greater than or equal to 3 in the hand/arm as measured by the medicated (ON) UPDRS question #20 or a postural/action tremor greater than or equal to a 2 for question #21 6. Significant disability due to PD tremor despite medical treatment (CRST score of 2 or above in any one of the items 16-23 from the Disability subsection of the CRST: [speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities]) 7. Tremor remains disabling when medical therapy is optimal or not tolerated for the treatment of other cardinal signs of PD (bradykinesia, rigidity, etc), as determined by a movement disorders neurologist or neurosurgeon at the site 8. Subjects should be on a stable dose of all PD medications for 30 days prior to study entry. 9. The thalamus must be apparent on MRI such that targeting of the Vim nucleus can be performed indirectly by measurement from a line connecting the anterior and posterior commissures of the brain. 10. Subject is able to communicate sensations during the ExAblate Transcranial procedure.
Exclusion criteria
Exclusion criteria: 1. Subjects with unstable cardiac status including: a) Unstable angina pectoris on medication b) Subjects with documented myocardial infarction within six months of protocol entry c) Significant congestive heart failure defined with ejection fraction 100 on medication) 4. Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc. 5. Significant claustrophobia that cannot be managed with mild medication. 6. Current medical condition resulting in abnormal bleeding and/or coagulopathy 7. Patient with severely impaired renal function with estimated glomerular filtration rate <30 ml/min/1.73m2 and/or who is on dialysis; 8. 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 9. 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 institutions laboratory standard 10. History of intracranial hemorrhage 11. Cerebrovascular disorder (multiple cerebrovascular disorder or cerebrovascular disorder that occurred within the last six months) 12. Subject who weigh more than the upper weight limit of the table or subjects who will not fit into the MR scanner 13. Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment. 14. Are participating or have participated in another clinical trial in the last 30 days 15. Subjects unable to communicate with the investigator and staff. 16. Presence of central neurodegenerative disease, including but not limited to Parkinson-plus syndromes, suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia with Lewy bodies, and Alzheimers disease. 17. Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications. 18. Presence of significant cognitive impairment as determined with a score = 24 on the Mini Mental Status E
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| using validated scores: on medication, Upper Limb tremor subscore (32 point maximum) from the 8 items of Parts A & B of the CRST, based upon TDPD subjects where unilateral ExAblate thalamotomy was attempted (i.e., Intent-to-Treat analysis).; | — |
Secondary
| Measure | Time frame |
|---|---|
| On-medication total CRST;CRST Disability subsection Part C; | — |
Countries
China
Contacts
Public ContactMeiyun Wang
Henan Provincial People’s Hospital
Outcome results
None listed