NCT04396470撤回1 期
Transcutaneous Vagus Nerve Stimulation in Children With Prader-Willi Syndrome
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Social Responsiveness Scale, 2nd Edition (SRS-2)
研究概览
简要总结
The purpose of the current project is to test the impact of transcutaneous vagus nerve stimulation (tVNS) on social ability in children with Prader-Willi Syndrome (PWS). Social ability and blood neuropeptides associated with social functioning will be measured before and after engagement in 12 weeks of tVNS therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) be between the ages of 8-14 years; (2) have a confirmed diagnosis of PWS by genetic testing; (3) be minimally verbal and able to sit at a table to complete cognitive and behavioral testing; (4) be willing to provide blood samples; and (5) be willing to engage in a 16-week study period (baseline to intervention follow-up).
排除标准
- •(1) currently taking oxytocin and/or arginine vasopressin or related analogs and (2) have a DSM-5 diagnosis of any severe mental or behavioral disorder (e.g. schizophrenia, bipolar disorder, conduct or oppositional defiant disorder) that significantly impacts daily functioning.
结局指标
主要结局
Social Responsiveness Scale, 2nd Edition (SRS-2)
时间窗: pre-post 12 week intervention period
Identifies the presence and severity of social impairments in child participants by parent report
次要结局
未报告次要终点
研究者
Karen Parker
Associate Professor of Psychiatry and Behavioral Sciences
Stanford University
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