Evaluation of Cochlear (Promontory) Stimulation During Awake Ear Surgery (TONES Study)

Обзор

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?

Подробное описание

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.

Вмешательства

• Устройство Electrical extracochlear stimulation
  Delivery of electrical extracochlear stimulation using electrodes on the middle ear surface. Real-time feedback from subjects on tolerability and auditory percepts

Первичные конечные точки

• Stimulation discrimination [Срок оценки: Time of study procedure]

Вторичные конечные точки (2)

• Threshold and most comfortable level [Срок оценки: Time of study procedure]
• Stimulation effects [Срок оценки: Time of study procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Cleveland Clinic — Cleveland

Идентификаторы

NCT: NCT07402941 · CLN-0001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗