NCT02963259已完成不适用
Prospective Evaluation Comparing the Effects of Constant Current Versus Constant Voltage in Deep Brain Stimulation Using Hybrid Systems
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 14
- 主要终点
- The Percentage of Subjects Who Indicate Preference on Constant Current Over Constant Voltage at the 3 Month Follow-up Visit.
研究概览
简要总结
This post-marketing evaluation has been designed to consistently investigate the subject's preference when switching from a Medtronic® constant voltage or constant current device to a St Jude Medical Infinity™ or St Jude Medical Brio™ constant current system. As electrodes will not be re-positioned, differences in subject's preference are to be explained by the difference in shape of the delivered pulse or waveform between the two systems.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject (and caregiver, if applicable) signed the approved Informed Consent;
- •Subject is ≥ 18 and ≤ 74 years of age;
- •Subject is bilaterally treated with deep brain stimulation (DBS) in the subthalamic nucleus (STN) using a constant voltage device (i.e. Soletra™, Itrel™, Kinetra™, ActivaPC™ or ActivaRC™ IPG) and is responding satisfactory to CV stimulation in the Investigator's opinion;
- •In the physician's opinion, the subject is a suitable candidate for an IPG replacement with different stimulation paradigm;
- •Subject needs and/or requests an IPG replacement within 12 months after consent and the current IPG has at least 2.6 V output left (i.e. approx. 30% of full battery capacity) at the time of subject enrollment;
- •PD symptom onset is no longer than 20 years;
- •Subject has a Hoehn & Yahr score <IV (on stim);
- •Subject with a normal cognitive function (MMSE ≥25);
- •Subject is fluent speaker (as judged by the investigator) of the language spoken in the country where the investigational site is located.
排除标准
- •IPG battery has less than 30% battery life at the time of consent;
- •Need to replace or reposition the leads or extensions during the IPG replacement procedure;
- •Subject had >10 recurrent falls experienced in the 3 months prior to consent;
- •Subject is unwilling to change to either a St Jude Medical Infinity™ or Brio™ DBS system for the IPG replacement;
- •Subject is unable to attend the study visits.
结局指标
主要结局
The Percentage of Subjects Who Indicate Preference on Constant Current Over Constant Voltage at the 3 Month Follow-up Visit.
时间窗: 3 Months
Proportion of subjects who preferred constant current device over constant voltage, tested against a performance goal (PG) of 50.0% at the 3-month follow-up visit.
次要结局
- Number of Events Per Patient-year of Follow-up(12 months after IPG replacement)
- Incidence Rate(12 months after IPG replacement)
研究者
研究点 (14)
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