Noninvasive Vagus Nerve Stimulation for Improved Speech in Noise Perception
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Safety and feasibility
研究概览
简要总结
Traumatic brain injury, a common injury in military service personnel, often leads to poor processing of speech in noisy environments. The goal of the current study is to better understand the brain basis for this difficulty and evaluate a new approach to improving speech in noise perception.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25-55 years old
- •Proficiency in English
- •TBI group: history of traumatic brain injury by blast or physical trauma
- •Normal hearing group: no history of traumatic brain injury
排除标准
- •Other neurological diseases or related conditions will be excluded (e.g., large vessel stroke, seizures). We will exclude patients with severe medical diseases that may be associated with impaired cognition (e.g., heart failure, dialysis dependent kidney disease, brain cancer). Further, psychiatric diseases that are unlikely to be related to trauma will be excluded (e.g., schizophrenia).
- •Patients with histories of severe psychiatric disease prior to trauma exposure will be excluded.
- •Current illicit or prescription drug abuse (within the last two months)
- •Any taVNS contraindication, including but not limited to the presence of unremovable metal in the left ear, known heart conditions, medications that influence neurotransmitters thought to be critical for vagus nerve stimulation (norepinephrine, acetylcholine, and serotonin), or implanted medical devices such as a pacemaker.
研究组 & 干预措施
Treatment A vs Treatment B
Participants will receive the stimulation at location A and then receive stimulation at location B, both on the outer ear.
干预措施: Cymba Conchae stimulation (Device)
Treatment A vs Treatment B
Participants will receive the stimulation at location A and then receive stimulation at location B, both on the outer ear.
干预措施: Earlobe stimulation (Device)
Treatment B then Treatment A
Participants will receive the stimulation at location B and then receive stimulation at location A, both on the outer ear.
干预措施: Cymba Conchae stimulation (Device)
Treatment B then Treatment A
Participants will receive the stimulation at location B and then receive stimulation at location A, both on the outer ear.
干预措施: Earlobe stimulation (Device)
结局指标
主要结局
Safety and feasibility
时间窗: From enrollment to the end of treatment is between 2 days and 2 weeks.
quantify attrition as well as frequency and severity of adverse events
次要结局
- Speech in Noise performance(Baseline and one week)
- Brain response patterns(Baseline and one week)