Efficacy of a Tinnitus Implant for People With Severe Tinnitus Without Damaging the Acoustic Hearing.

Официальное название

Extracochlear Electrical Stimulation in Patients With Intractable Tinnitus - a Feasibility Study

Обзор

This is a prospective, intervention-based, non-randomized, pre-post, single-site feasibility study that will involve data collection from individuals with intractable tinnitus. The study comprises a screening under local anesthesia and a surgery to implant the medical device. The screening will allow for accurate selection of patients. For patients not fulfilling the criteria for chronic extracochlear stimulation, the study will stop there. Patients eligible for chronic stimulation will undergo a second surgery under general anaesthesia involving the implantation of a cochlear implant with an electrode placed outside the cochlea in the vicinity of the round window. Each surgical procedure will be followed by a series of medical check-ups. Following implantation, the safety and efficiency of extracochlear chronic stimulation will be evaluated as well as the tinnitus suppression and speech perception.

Вмешательства

• Устройство Extracochlear stimulation
  The study will implant a cochlear implant extracochlearly, near the round window.

Первичные конечные точки

• Number of participants with treatment-related adverse events [Срок оценки: 12 months post-operatively]
• Hearing loss [Срок оценки: 12months postoperatively]
• Tinnitus suppression [Срок оценки: 6 months and 12 months]

Вторичные конечные точки (1)

• speech perception in quiet and in noise [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Proficient in written and spoken Dutch, defined by self-report or the researcher
• Intractable severe/uncompensated unilateral tinnitus, evaluated by VAS-score, and confirmed by Tinnitus functionality Index (TFI) and Tinnitus Questionnaire (TQ) (global TFI score of 54 and above and global TQ-score of 47 and above)
• Suffering from tinnitus for at least a year
• Not responsive to the normally available clinical tinnitus treatment.
• High-frequency sensorineural hearing loss in the ear to be treated
• Hearing aid did not provide any tinnitus suppression
• Ability to use the device and follow a personalized rehabilitation program.
• Ability to undergo the surgery

Критерии исключения

• Chronic middle ear pathology
• Surgical anatomy not allowing for implantation, evaluated by CBCT/MRI imaging
• Tinnitus suppression is possible to achieve with hearing aids (as per self-report/documentation)
• Clinically significant depression (HADS-score of 11 and above)
• Active treatment, or treatment in the past 6 months, with either a chemotherapeutic drug for cancer, or radiation therapy to the head or neck region
• Pregnant or breastfeeding women
• Current participation in another interventional clinical study/trial in the past 30 days involving an investigational drug or device.
• Medical contra-indications to middle ear surgery, and/or anesthesia
• Cholesteatoma in the ear to be treated

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

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07648615 · TIN2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗