JPRN-jRCTs032180306已完成1 期
A feasibility Clinical Trial of the Management of the Medically Refractory Dyskinesia Symptoms of Advanced Idiopathic Parkinson's Disease With Unilateral Lesioning of the Globus Pallidum Using the Exablate Transcranial System
Kimito Kondo0 个研究点目标入组 7 人开始时间: 2019年3月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
研究概览
简要总结
Some evaluations such as MDS-UPDRS Part III (OFF), MDS-UPDRS Part IV, and UDysRS showed improvement in symptoms, but in terms of exercise in daily life, the score was lower at 3 months after surgery compared to the evaluation at screening. Decrease, then increase was confirmed, and it was found that the symptoms gradually returned. There was no change in the average dose of L-dopa. Adverse events were confirmed as serious adverse events, but none were attributable to the conduct of the study.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 30age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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
- •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
研究者
相似试验
已完成
不适用
Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus OstiaChronic SinusitisNCT02228720Intersect ENT15
已完成
3 期
Efficacy and Safety of FS VH S/D 4 S-apr for Flap Adherence in RhytidectomyFace-liftFacial RhytidectomyNCT00999141Baxter Healthcare Corporation75
终止
2 期
Controlled Trial of 3,4-Diaminopyridine (3-4DAP) in Lambert-Eaton Myasthenic Syndrome (LEMS)Muscle WeaknessNCT02090725Jeffrey A. Cohen, MD4
已完成
3 期
Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's DiseaseCrohn's DiseaseNCT01541579Tigenix S.A.U.278
终止
3 期
Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMAMDSRefractory Anemia With Excess BlastsRAEBMyelodysplastic SyndromeNCT02562443Traws Pharma, Inc.372