JPRN-jRCTs032180407
Suspended
Phase 1
Feasibility Study to Evaluate the Safety and Effectiveness of Bilateral Magnetic Resonance-guided Focused Ultrasound (MRgFUS) Ablation of the Pallido-Thalamic Tract for the Treatment of Advanced Parkinson's Disease - PD005
Ikezawa Jun0 sites10 target enrollmentMarch 22, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ikezawa Jun
- Enrollment
- 10
- Status
- Suspended
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Men and women age 30 years and older
- •2\.Patients who are able and willing to give consent and able to attend all study visits
- •3\.A diagnosis of idiopathic Parkinson's Disease by UK Brain Bank Criteria as confirmed from clinical history and examination by a neurologist specializing Parkinson's disease by the presence of tremor at rest, bradykinesia and rigidity
- •4\.Levodopa responsive as defined by at least a 30% reduction in MDS\-UPDRS motor subscale in the ON vs OFF medication state.
- •5\.Symptoms have been resistant to optimal pharmacologic treatment including L\-dopa and other antiparkinsonian drugs for at least 1 year.
- •6\.Subjects on stable (i.e., no change in medication drug or dosage for 3 months) antidepressant medications for at least 3 months may be enrolled into this study.
- •7\.Disabling motor complications of PD on optimum medical treatment (dyskinesia etc.) characterized by at least one of the two most clinically relevant symptoms (e.g. tremor at rest or dyskinesia \- must have a score of \>\= 3 on the MDS\-UPDRS, questions 3\.17a\-e or 4\.2\).
- •8\.Strongly diminished quality of life.
- •9\.The pallido\-thalamic region can be targeted by the ExAblate device.
- •10\.Able to communicate sensations during the ExAblate MRgFUS treatment.
Exclusion Criteria
- •1\.Patients with unstable cardiac status including:
- •a)Unstable angina pectoris on medication
- •b)Patients with documented myocardial infarction within six months of protocol entry
- •c)Congestive heart failure requiring medication (other than diuretic)
- •d)Patients on anti\-arrhythmic drugs
- •2\.Criteria outlined in the DSM\-IV as manifested by one (or more) of the following occurring within a 12 month period:
- •a)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).
- •b)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)
- •c)Recurrent substance\-related legal problems (such as arrests for substance related disorderly conduct)
- •d)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).
Outcomes
Primary Outcomes
Not specified
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