Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus: An Early Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of subjects with treatment-related adverse events
研究概览
简要总结
Researchers are gathering information on the safety and effectiveness of a novel device called the Tinnitus Implant System for the treatment of tinnitus.
详细描述
This study requires one year of participation with at least 21 visits to Mayo Clinic in Rochester MN for device programming and audiometric testing. The device is implanted during an outpatient surgery. Participants may keep the study device after participation is complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age: ≥18 years of age
- •Normal to moderate SNHL (≤70 dB HL; based on PTA of 0.5, 1 and 2 kHz) and WRS ≥60% in the ear to be implanted
- •Asymmetric or unilateral subjective tonal tinnitus
- •Subjectively severe tinnitus present for at least 6 months, but not longer than 12 years; it is permissible to include people who have had intermittent or constant tinnitus longer than 12 years as long as it was not perceived as severe longer than 12 years
- •Tinnitus that is disruptive by at least two of the three criteria:
- •THI in the severe range (≥56/100) TFI in the severe range (≥52/100) Tinnitus VAS-A or Tinnitus VAS-L ≥50/100
- •Tinnitus that is intractable, and has not been ameliorated by conventional measures such as a hearing aid or masking, when such interventions are potentially clinically indicated (e.g., it is not expected that people with minimal or no hearing loss would trial a conventional hearing aid)
- •MRI of the head that does not reveal any anatomical or structural abnormalities of the inner ear, cochlear nerve, or brainstem that would negatively impact response to study intervention (e.g., vestibular schwannoma)
- •Temporal bone CT that does not reveal any major anatomical or structural abnormalities that would negatively impact response to study intervention
- •Participants must be able to read, understand, and provide informed consent to participate in the trial
- •Participants must be willing and anticipate being able to return for study procedures and follow up visits
- •Participants must have completed participation in the study entitled "Cochlear Promontory Stimulation for Treatment of Tinnitus: Towards Developing an Implantable Device" (IRB 17-004832) at Mayo Clinic
排除标准
- •Age: <18 years of age
- •Subjectively severe tinnitus present less than 6 months or longer than 12 years; it is permissible to include people who have had intermittent or constant tinnitus longer than 12 years as long as it was not perceived as severe longer than 12 years
- •History of brain or major ear surgery
- •History of brain or temporal bone tumor(s)
- •Recurrent ear infections within the last year
- •Prior major head trauma, defined for the purposes of this study as head trauma that results in sudden injury that causes damage to the brain and results in lasting cognitive impairment
- •Ongoing clinical diagnosis of depression or anxiety; for the purposes of this study, it is permissible to include people who:
- •have a past history of clinically diagnosed depression or anxiety that is no longer currently active; or
- •people who have depressive or anxious symptoms that are thought to primarily result from severe tinnitus
- •Presence of clinically significant depressive or anxiety symptoms determined by screening using the GAD-7, PHQ-8, and SHIA questionnaires GAD-7 score >9 (indicates clinically significant anxiety) PHQ-8 score >9 (indicates clinically significant depression) SHAI score >25 (hypochondriacal level illness anxiety)
- •Currently taking regularly scheduled antidepressant, anxiolytic, antipsychotic or antiepileptic medications, or other neuromodulatory agents; for this study, it is permissible to include people who use such medications at lower doses as a sleep aid or for people who intermittently use such medications for situational anxiety (e.g., Ativan before airplane travel)
- •Active use of other tinnitus treatments; for the purposes of this study it is permissible to include people who prefer to use a hearing aid to amplify ipsilateral hearing loss
- •Known pregnancy at time of surgery
- •Any medical condition, including mental illness or substance abuse, deemed by the PI to likely interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
研究组 & 干预措施
Subject with severe tinnitus
Subjects diagnosed with severe tinnitus for at least six months, and it has not responded to conventional management will have surgical implantation of the device Tinnitus Implant System.
干预措施: Tinnitus Implant System (Device)
结局指标
主要结局
Number of subjects with treatment-related adverse events
时间窗: One year
Measured by subjects meeting one or more of the following criteria: worsening bone conduction thresholds in any tested frequency (0.25, 0.5, 1, 1.5, 2, 3, or 4 kHz) from baseline by a clinically significant amount (\>10 dB) or worsening in WRS from baseline by a clinically significant amount (\>20%) or worsening in video head impulse test result from baseline or one or more serious AEs
Number of subjects to experience significant improvement from implantation of the device
时间窗: Baseline, 3 weeks, 5 weeks, 7 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, 52 weeks
Measured by subjects meeting at least two of three measurements of tinnitus severity: Tinnitus Handicap Inventory (THI) improvement by greater than 7 points using a 25-item self-assessment questionnaire with possible answers of Yes (4 points), Sometimes (2 points), and No (0 points) or Tinnitus Functional Index (TFI) improvement by greater than 13 points using a 25-item self-report questionnaire on a scale of 0 to 10 with a maximum possible score of 250 or Tinnitus visual analog scale improvement by greater than 15 points using a self-reported scale consisting of a 10 cm line with verbal descriptors (word anchors) at each end to express the extremes of the symptom; 0 mm designates no pain and 100 mm designates the greatest imaginable severity of pain.
次要结局
未报告次要终点
研究者
Matthew L. Carlson, M.D.
Principal Investigator
Mayo Clinic