NCT04547712已完成不适用
Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 19
- 主要终点
- Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold.
研究概览
简要总结
The purpose of the study is to demonstrate the safety and effectiveness of adaptive DBS (aDBS) for Parkinson's disease.
详细描述
Prospective single-blind, randomized crossover, multi-center study of aDBS in subjects with Parkinson's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has idiopathic Parkinson's disease
- •Subject is implanted with Percept PC (Model B35200) and Medtronic Deep Brain Stimulation (DBS) leads (Model 3387, 3389, B33005 or B33015) and extensions (Model 37085, 37086, or B34000) bilaterally in the same target (physician confirmed), subthalamic nucleus (STN) or Globus Pallidus (GPi)
- •In the opinion of the investigator, the subject responds to DBS Therapy.
- •Based on the opinion of the investigator, the subject's cDBS parameters and PD medications are stable and expected to remain stable from enrollment through the end of the aDBS Evaluation phase
- •(Primary Cohort) Subject is configured to ring mode monopolar or dual monopolar stimulation using contacts 1 and/or 2 (9 and/or 10) on at least one side.
- •(Directional Stimulation Cohort) Subject is configured to directional monopolar or dual monopolar stimulation using contacts 1 and/or 2 (9 and/or 10)
- •Subject is willing and able to attend all study-required visits and complete the study procedures (e.g. 1-month recall questionnaires, MDS-UPDRS III)
- •Subject has the ability to understand and provide written informed consent for participation in the study prior to the study-related procedures being conducted
- •Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using, or agree to use, a medically-acceptable method of birth control as confirmed by the investigator
- •For subjects with the SenSight system: Subject is configured to the following stimulation rates: 55, 85, 110, 125, 145, 164 or 180 Hz (as required for sensing/aDBS)
- •Local Field Potential (LFP) Screening Inclusion Criteria
- •Subject has required Alpha-Beta band (8-30 Hz) amplitude ≥ 1.2 µVp detected on either left and/or right DBS leads
排除标准
- •Subject and/or caregiver is unable to utilize the patient programmer
- •Subject has more than one lead in each hemisphere of the brain
- •Subject has cortical leads or additional unapproved hardware implanted in the brain
- •Subject has more than one INS
- •At enrollment, the subject's INS has a predicted battery life of <1 year
- •Subject has Beck Depression Inventory II (BDI-II) > 25
- •Subject requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
- •Subject has a metallic implant in the head, (eg, aneurysm clip, cochlear implant)
- •Subject has, or plans to obtain, an implanted electrical stimulation medical device anywhere in the body (eg, cardiac pacemaker, defibrillator, spinal cord stimulator)
- •Subject has, or plans to obtain, an implanted medication pump for the treatment of Parkinson's disease (eg, DUOPATM infusion pump) and/or portable infusion pump
- •Based on the opinion of the investigator, the subject has an abnormal neurological examination that would preclude them from study participation
- •Subject is breast feeding
- •Subject is under the age of 18 years
- •Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study as determined by the Medtronic study team
- •Subject is unable to use or tolerate wearable
- •Subjects with signal artifact on all 6 aDBS sense pathways (3 each on both DBS leads) which preclude the clinician from setting thresholds
结局指标
主要结局
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold.
时间窗: About one month
In the PD Home Diary, in 30-minute intervals, patients recorded whether they were in the "On" condition (with dyskinesia, with non-troublesome dyskinesia, with troublesome dyskinesia), "Off" condition, or asleep. The "On" time without troublesome dyskinesia combined the categories of "On" time without dyskinesia and "On" time with non-troublesome dyskinesia. The PD Home Diary was collected at both the cDBS Baseline and aDBS Evaluation Phases. The threshold was determined using the hours of "On" time without troublesome dyskinesia for aDBS is no worse than 2 hours per day less than cDBS. The proportion of aDBS subjects exceeding the threshold was the primary endpoint.
次要结局
- Stimulation Energy Use(About one month)
研究者
研究点 (19)
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