Neural and Kinematic Features of Freezing of Gait for Adaptive Neurostimulation

Stanford University1 个研究点分布在 1 个国家目标入组 12 人2017年5月15日

适应症Parkinson Disease

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Parkinson Disease
发起方: Stanford University
入组人数: 12
试验地点: 1
主要终点: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Related to aDBS
状态: 已完成
最后更新: 6年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

Continuous deep brain stimulation (cDBS) is an established therapy for the major motor signs in Parkinson's disease, however some patients find that it does not adequately treat their freezing of gait (FOG). Currently, cDBS is limited to "open-loop" stimulation,without real-time adjustment to the patient's state of activity, fluctuations and types of motor symptoms, medication dosages, or neural markers of the disease. The purpose of this study is to determine if an adaptive DBS system,responding to patient specific, clinically relevant neural or kinematic feedback related to FOG, is more effective than continuous DBS on the motor Unified Parkinson's Disease Rating Scale (UPDRS III) and gait measures of PD.

注册库

clinicaltrials.gov

开始日期

2017年5月15日

结束日期

2018年10月31日

最后更新

6年前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Stanford University

责任方

Principal Investigator

主要研究者

Helen M. Bronte-Stewart

John E. Cahill Family Profressor, Professor of Neurology and, by courtesy, Neurosurgery at the Stanford University Medical Center

Stanford University

入排标准

入选标准

•A diagnosis of idiopathic Parkinson's disease, with bilateral symptoms at Hoehn and Yahr Stage greater than or equal to II.
•Documented improvement in motor signs on versus off dopaminergic medication, with a change in the Unified Parkinson's Disease Rating Scale motor (UPDRS III) score of \>= 30% off to on medication.
•The presence of complications of medication such as wearing off signs,fluctuating responses and/or dyskinesias, and/or medication refractory tremor,and/or impairment in the quality of life on or off medication due to these factors.
•Subjects should be on stable doses of medications, which should remain unchanged until the DBS system is activated. After the DBS system is optimized(during which time the overall medication dose may be reduced to avoid discomfort and complications such as dyskinesias) the medication dose should remain unchanged, if possible, for the duration of the study.
•Treatment with carbidopa/levodopa, and with a dopamine agonist at the maximal tolerated doses as determined by a movement disorders neurologist.
•Ability and willingness to return for study visits, at the initial programming and after three, six and twelve months of DBS.
•Has a history of and/or displays freezing of gait

排除标准

•Subjects with significant cognitive impairment and/or dementia as determined bya standardized neuropsychological battery.
•Subjects with clinically active depression, defined according to the Diagnostic and Statistical manual of Mental Disorders, Fourth Edition (DSM-IV) criteria and as scored on a validated depression assessment scale.
•Subjects with very advanced Parkinson's disease, Hoehn and Yahr stage 5 on medication (non-ambulatory).
•Subjects with an implanted electronic device such as a neurostimulator, cardiac pacemaker/defibrillator or medication pump.
•Subjects, who are pregnant, are capable of becoming pregnant, or who are breast feeding.
•Patients with cortical atrophy out of proportion to age or focal brain lesions that could indicate a non-idiopathic movement disorder as determined by MRI
•Subjects having a major comorbidity increasing the risk of surgery (prior stroke,severe hypertension, severe diabetes, or need for chronic anti-coagulation other than aspirin).
•Subjects having any prior intracranial surgery.
•Subjects with a history of seizures.
•Subjects, who are immunocompromised.