Parkinson's Disease
Conditions
Interventions
MRguided focused ultrasound transcranial pallidotomy
Sponsors
Kimito Kondo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Men and woman,age 30 years and older. 2.Subjects who are able and willing to give informed consent and able to attend all study visits through 24 Month. 3.Subjects wtih a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by 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 OFFcondition 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 condion) 7.Predominant disability from one side of the body. 8.Subjects is able to communicate sensation during the ExAblate Neruo prosedure. 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.These include:multisystem atrophy,dementia with Lewy bodies,and Alzheimer's disease. 3.Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medication. 4.Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia. 5.Presence of significant cognitive imparrirment defined as score100 on medication) 12.Current medical condition resulting in abnormal bleeding and / or coagulopathy 13.Receiving anticoagulant (e.g.warfarin) or antiplatelet (e.g.aspirin) therapy within one week of focused ultrasound prosedure. 14.Subjects with risk factors for intraoperative or postoperative bleeding as indicated by : documented clinical coagulopathy,or INR coagulation studies ezceeding the institution's standard. 15.Patient with severely impaored renal function with estimated blomerular filtration rate < 30 ml/min/1.73m2 (or per local standaeds should that be more restrictive) and / or who is on dialysis; 16.Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices incuding cardiac pacemakers,size limitations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the level of effectiveness of the ExAblate Transcranial pallidotomy to manage the dyskinesia of subjects with medication-refractory, advanced idiopathic PD. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the incidence and severity of adverse events (AEs) associated with ExAblate Transcranial method of pallidotomy in subjects with medication-refractory, advanced idiopathic PD. | — |
Contacts
Public ContactAiko Tamura
Hokuto hospital
Outcome results
None listed