PD002J

JRCT ID: jRCTs032180306

Registered date:15/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Parkinson's Disease
• Date of first enrollment: 19/04/2016
• Target sample size: 10
• Study type: Interventional
• Intervention(s): MRguided focused ultrasound transcranial pallidotomy

Outcome(s)

Primary Outcome

To determine the level of effectiveness of the ExAblate Transcranial pallidotomy to manage the dyskinesia of subjects with medication-refractory, advanced
idiopathic PD.

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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 score<21 on the Montreal Cognitive Assessment(MoCA)or Mattis Dementia Rating Scale of 120 or lower.
6.Unstable psychiatric desease,delusions,hallucinations,or suicidal ideation.Subjects with stable,chronic anxiety or depressive disorders may be included provided their medivcations have been stable for at least 60 days prior to study prior to study entry and if deemend appropriately managed bay the sited neuropyschologyst.
7.Subjects with significant depression as determined
following a comprehensiveassessment by a
neuropsychologist.Significant depression is being
defined quantitativelty asa a score of greater than 14
on the Beck Depression Inventory.
8.Legal incapacity or limited legal capacity as determined by the neuropsycholgist.
9.Subjects exhibiting any behavior(s) consistent with ethnol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one(or more)of the following occurring within the preceding 12month 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
performancerelated to substance use;substance-related
absences,suspensions,or expulsions from school;or neblect of children or
household)
b.Recurrent substance use in situations in which it is physically hazardous
(such asdriving an automobile or operating a machine when impaored by
substance use)
c.Recurrent substance-related legal problems(such as arrests for substance
related disorderly conduct)
d.Continued substance use despite having caused or exacerbated by the
effects of the substance(for example,arguments with spouse about
consequences of intoxication and physical fights)
10.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 <40
d.Subjacts with unstable ventricular arrhythmias
e.Subjects with atrial arrhythmias that are not rete-controlled
11.Severe hypertension(diastolic BP>100 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,etc.
17.Significant claustrophobia that cannot be managed with mild medication.
18.Subject who weigh more than the upper weight limit of the Mr scanner table who cannot fit into the MR scanner.
19.Subjects who are not able or willing totolerate the required prolonged stationary supine position during treatment.
20.History of intracranial hemorrhage
21.History of multiple strokes,or a stroke within past 6month.
22.Subjects with a history of seizures within the past year.
23.Subjects with brain tumors.
24.Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment.
25.Are participating or have participated in another clinicaltrial in the last 30 days.
26.Any illness that in the investigator's opinion preclude participation in this study.
27.Subject unable to communicate wtih the investigator and staff.
28.Pregnancy or lavtation.
29.All patients with sever premorbid risks (MDS-UPDRS Part2 subsection activities of daily living scores of a three or four in question 2.1(speech),question 2.2(salivation),or question 2.3 (swallowing) )will be exculded.

Related Information

• Primary Sponsor: Kimito Kondo
• Source(s) of Monetary Support: InSightec.ltd