Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 6
- 主要终点
- Change in Therapeutic Window Size With Selected Contact at the Informity Programming Visit Compared to Baseline
研究概览
简要总结
The objective of this clinical investigation is to characterize the clinical performance of Abbott's Clinician Programmer Electrode Screening Mode tool (InformityTM tool) in programming InfinityTM deep brain stimulation (DBS) systems for patients with Parkinson's disease (PD) or essential tremor (ET).
详细描述
This is a prospective, non-randomized, single-arm, multi-center, post-market clinical investigation designed to evaluate Abbott's Informity tool for Infinity DBS systems.
This clinical investigation will be conducted at up to 5 centers in the United States.
Up to 40 patients were intended to enroll in the study. However the study was stopped after enrolling 8 subjects at 3 sites.
Subjects participating in this clinical investigation will be followed for 6 months. The expected duration of enrollment is 6 months. The total duration of the clinical investigation is expected to be 18 months. The primary and secondary endpoints will be evaluated when all subjects have completed their 6 month follow-up visits
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Outcomes assessor will be masked to subjects' deep brain stimulation programming.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Therapeutic Window Size With Selected Contact at the Informity Programming Visit Compared to Baseline
时间窗: At Day 21 compared to baseline
Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing.
Change in Therapeutic Window Size With Best Contact at the Informity Programming Visit Compared to Baseline
时间窗: At Day 21 compared to baseline
Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing.
Change in Therapeutic Electrical Energy Delivered (TEED) With Selected Contact at the Informity Programming Visit Compared to Baseline
时间窗: At Day 21 compared to baseline
TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing.
Change in Therapeutic Electrical Energy Delivered (TEED) With Best Contact at the Informity Programming Visit Compared to Baseline
时间窗: At Day 21 compared to baseline
TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing.
次要结局
- Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 3 Months(At 3 months compared to baseline)
- Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 6 Months(At 6 months compared to baseline)
- Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at Baseline(At baseline)
- Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 Months(At 3 months)
- Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 Months(At 6 months)
- Mean Duration of Programming(At Day 21)
- Change in Therapeutic Electrical Energy Delivered (TEED) at 3 Months(At 3 months compared to baseline)
- Change in Therapeutic Electrical Energy Delivered (TEED) at 6 Months(At 6 months compared to baseline)