ACTRN12622001562763招募中未知
Investigating the feasibility and tolerability of home-based, remotely-supervised transcranial direct current stimulation (tDCS) during attention training in children with acquired brain injury
Professor Karen Barlow0 个研究点目标入组 30 人开始时间: 2022年12月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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
- 8 Years 至 18 Years(—)
- 性别
- All
入选标准
- •Aged between 7 and 18 years (inclusive)
- •Acquired brain injury (including mild to severe TBI)
- •English language skills sufficient to comprehend study information and complete assessments (self-report)
- •At least 3 months post injury (for mild TBI)
- •At least one year post-injury (for moderate – severe TBI)
- •Access to internet at home
- •TBI injury severity
- •Mild: Received a Glasgow coma scale (GCS) score of between 13 and 15 upon ED evaluation (if available); experienced <24 h post-traumatic amnesia (PTA)
- •Moderate: Loss of consciousness between 30 min and 24 h; GCS between 9 and 12; PTA between 24 h and 7 days]
- •Severe: GCS<9; PTA for more than 7 days]
排除标准
- •Contra-indications to tDCS e.g.
- •- Metal implants
- •- Serious or unstable illness or medical condition
- •- Current or suspected pregnancy or current lactation
- •- Skull defects underneath stimulation sites
- •- Scalp wound/skin problem preventing placement of EEG and stimulation leads
- •- Epilepsy or other seizure disorders
- •Acquired brain injury due to hypoxic-ischemic encephalopathy
- •Significant past medical or psychiatric history before injury
- •Profound memory impairments according to medical history
- •Recent or planned change in neuroactive drugs (i.e., changed within 3 weeks of tDCS; e.g., anticonvulsants, benzodiazepines, GABA antagonists, etc.).
- •Pre-existing neurological disorder, including moderate to severe learning difficulties
- •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.
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