ISRCTN16552390已完成不适用
Transcutaneous vagal nerve stimulation for episodic aggression: a feasibility and pilot study
Cambridge and Peterborough NHS Foundation Trust (UK)0 个研究点目标入组 12 人开始时间: 2016年7月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
- 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29457585.
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. A diagnosis of an intellectual disability, autism or acquired brain injury
- •2. Male and female participants aged 18-55 years
- •3. Capacity to consent to participation in the study
- •4. Manifestation of at least one episode of verbal or physical aggression per week, when averaged over the preceding four weeks
- •5. Agreement from participants’ family and/or paid carers to support the trial
排除标准
- •1. The presence of a diagnosis of an affective or psychotic condition considered to underpin the aggressive episodes
- •2. The presence of current drug or alcohol dependence
- •3. A current diagnosis of epilepsy
- •4. Significant physical comorbidity that could interact with trial participation (for instance ongoing cardiac arrhythmias, active implants such as a cardiac pacemaker or a cochlear implant, wounds and diseased skin in the area of the tVNS electrodes)
- •5. Current or recent (previous 12 months) participation in a clinical trial of an investigational medicinal product (CTIMP) or medical device.
- •6. Pregnancy
研究者
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