Effect of Non-invasive Vagus Nerve Stimulation on Letter Learning in Dyslexia
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
This is a pilot study to establish feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) for improving letter-learning in adolescents with dyslexia. The main goals of the study are to 1) evaluate whether children in this age range will tolerate low level stimulation over the course of multiple sessions, 2) determine whether low level taVNS improves novel letter learning in dyslexia, and 3) evaluate the effect of low level taVNS on the brain's response to letters. Participants will complete fMRI before training, immediately after training, and a few weeks after training ends. Training will consist of six 30-minute lessons during which participants will learn novel letter-sound relationships while receiving either active or sham taVNS. Researchers will compare stimulation conditions to determine effect of this device on learning and neural plasticity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
All participants will be told they are receiving active stimulation at a custom current level that may or may not be detectable to them. Half of the participants (randomly assigned) will not receive stimulation.
入排标准
- 年龄范围
- 10 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal non-verbal IQ
- •Reading scores above 90 on four single word reading measures (typical reader) OR reading scores below 90 on two or more single word reading measures (dyslexia) with or without ADHD
排除标准
- •Neurological diagnoses (e.g., autism, epilepsy, etc.)
- •Medications other than those prescribed for ADHD
- •Nonverbal IQ below 80
研究组 & 干预措施
Active taVNS
Participants will receive custom current at 5 Hz to the left auricular branch of the vagus nerve while learning new letter-sound relationships.
干预措施: active taVNS (Device)
Sham taVNS
Participants will undergo current thresholding but device will be turned off without their knowledge during the training.
干预措施: sham taVNS (Device)
结局指标
主要结局
Adverse events
时间窗: 4 weeks
Frequency and severity of adverse events will be monitored and evaluated for severity and impact on attrition.
Compliance
时间窗: 4 weeks
Percentage of the population that remains engaged in the study and completes all stimulation sessions.
次要结局
- Letter ID(6 weeks)
- Decoding(6 weeks)
- Automaticity(6 weeks)