ACTRN12619001118190尚未招募2 期
A single centre, double-blind, randomized controlled trial investigating repetitive transcranial magnetic stimulation (rTMS) to treat persistent post-concussion symptoms in children
Associate Professor Karen Barlow0 个研究点目标入组 54 人开始时间: 2019年8月12日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 11 Years 至 18 Years(—)
- 性别
- All
入选标准
- •1.Male or female, 11-18 years of age inclusive (at time of initial pre-screening), currently experiencing post concussive symptoms.
- •2.Documentation of persistent post concussive symptoms as evidenced by two or more clinical symptoms: headache, difficulty concentrating or remembering, sleep problems, dizziness, fatigue or nausea/vomiting – not explained by another disorder.
- •3.Post concussive symptoms for more than/equal to 2 months.
- •4.No history of rTMS treatments.
排除标准
- •1.Epilepsy or other seizure disorders.
- •2.Chronic treatment with psychotropic medication or any other medications deemed unsuitable for TMS application as deemed by the Investigator.
- •3.Neurological disorders, including moderate to severe learning difficulties.
- •4.Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- •5.Females of child-bearing potential only: Pregnant as confirmed by urine pregnancy test at baseline visit; and unwillingness to use contraception from pre-screening to follow-up visit (if sexually active); currently breastfeeding.
- •6.No recreational drug use.
研究者
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