NCT04677751招募中不适用
Clinical and Electrographic Changes in RNS System Patients with Acupuncture Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Percent change in number of disabling clinical seizures
研究概览
简要总结
The purpose of this study is to determine effects of Acupuncture on a Patient's mood and cognition,evaluate changes in clinically-reported seizure frequency and severity and analyze effects of Acupuncture on electrographic epileptiform activity stored by the RNS System
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
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient implanted with the RNS system
- •Patient can undergo 12 weeks of acupuncture
- •Patient is able remain on stable medications for 12 weeks
- •Patient is able to remain on stable Detection and Stimulation settings for 12 weeks
- •Patient or/and caregiver is able to understand and sign informed consent and HIPAA authorization
- •Patient or caregiver able to maintain a seizure diary for duration of study
排除标准
- •Patient and /or caregiver is unable to sign informed consent to study
- •Patient has a bleeding disorder, pacemaker, or pregnant
结局指标
主要结局
Percent change in number of disabling clinical seizures
时间窗: Baseline,12 weeks post treatment
This will be measured by self reporting journals
Changes in seizure severity
时间窗: Baseline,12 weeks post treatment
This will be measured by self reporting journals
次要结局
- Average number of detections of seizures per-day (as stored by the RNS System)(1 month after last treatment)
- Change in cognition and mood as assessed by the Quality Of Life In Epilepsy (QOLIE-10) questionnaire(Baseline,12 weeks post treatment)
- Change in cognition and mood as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) scale(Baseline,12 weeks post treatment)
- Change in cognition and mood as assessed by the Patient Health Questionnaire (PHQ-9)(Baseline,12 weeks post treatment)
研究者
Olga Rodziyevska
Physician Assistant
The University of Texas Health Science Center, Houston
研究点 (2)
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