Evaluation of Cochlear (Promontory) Stimulation During Awake Ear Surgery (TONES Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Stimulation discrimination
研究概览
简要总结
The goal of this clinical trial is to learn if short electrical signals can be heard in adult subjects who are otherwise having surgery on their ear.
The main question it aims to answer is:
Can an individual accurately hear different frequencies resulting from the short electrical signals?
详细描述
The goal of this interventional clinical study is to investigate the feasibility for minimally invasive electrical stimulation of the cochlea as a mechanism for hearing restoration. The main aims of the study are to:
Establish comfortable and tolerable auditory thresholds Investigate the relationship between the position of stimulation, the stimulation parameters and the perceived frequency of any auditory sensation.
This study will enroll patients undergoing middle ear surgery where a brief study procedure will be performed during the course or their surgery. Participants will provide real-time feedback on any auditory sensations and percepts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual is ≥ 18 years old at the time of consent.
- •Individual is scheduled for awake ear surgery that will expose the middle ear (subannular tympanostomy tube placement, tympanoplasty, stapes surgery).
- •Individual is willing to complete intraoperative assessments of promontory stimulation.
排除标准
- •Individual has had severe-to-profound hearing loss for more than 30 years.
- •Individual has congenital hearing loss (for the purpose of this study, onset prior to 2 years of age)
- •Ear canal will not accommodate a speculum with minimum outer diameter (OD) of 4.0 mm or other anatomic challenges present as determined by the study investigator
- •Hearing loss or auditory processing disorder of neural or central origin
- •Active middle ear infection
- •History of cholesteatoma treated within the past 2 years
- •Ossification of the cochlear or other previously identified cochlear anomaly
- •Prior major head trauma (stroke, hemorrhage, traumatic brain injury) within past 2 years
- •Contralateral presence of cochlear implant
- •Individual is pregnant.
- •Individual is unable or unwilling to complete training for qualitative evaluation of promontory electrical stimulation.
- •A disability that could interfere with intraoperative evaluations as determined by study investigator.
- •Profound tinnitus
- •History of vertigo that would interfere with the planned investigation as determined by the principal investigator
研究组 & 干预措施
Electrical extracochlear stimulation
Electrical extracochlear stimulation and psychoacoustic testing
干预措施: Electrical extracochlear stimulation (Device)
结局指标
主要结局
Stimulation discrimination
时间窗: Time of study procedure
Accuracy of comparison of paired stimulation presentations as indicated by subject. This will be measured using a same-different task, where two stimulation paradigms are compared. The participant will be presented two consecutive stimuli, randomized to be the same or different. The participant will verbalize whether they felt the stimuli were the same or different. This will be repeated five times and graded on a percentage scale.
次要结局
- Threshold and most comfortable level(Time of study procedure)
- Stimulation effects(Time of study procedure)