A Blinded Randomized Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus vs. VNS With Unpaired Tones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Number of Participants With Serious Adverse Events
研究概览
简要总结
Assess the safety and efficacy of VNS paired with tones for tinnitus using a randomized, controlled, parallel study design.
详细描述
Patients who have moderate to severe tinnitus, at least one year post diagnosis, may enroll. All patients will be implanted and randomized to one of two groups:
- a group receiving VNS paired with tones and;
- a group that receives VNS and tones, but with different settings.
After device use training, therapy is delivered at home by the patient for 6 weeks. Patients have eight baseline audiometric assessments along with two questionnaire assessments, an assessment after recovery before treatment starts, and tinnitus assessments every two weeks during therapy through the 6 week randomized portion of the study. After the randomized portion, all patients receive VNS paired with tones. Patients will continue to return for quarterly visits and tinnitus assessments through the first year after implant, regardless of their therapy status. Interested patients can continue to receive longer-term treatment after the first year. A goal of up to 30 patients enrolled and implanted across four sites is planned for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •22 to 65 years of age
- •Have been diagnosed as suffering from sensorineural tinnitus and at least some tonal quality of the tinnitus
- •Unilateral or bilateral tinnitus
- •Have experienced tinnitus for at least one year and failed at least one tinnitus therapy (such as a counseling or sound therapy procedure. The diagnosis of tinnitus will include an audiological or medical diagnosis in their health records, as well as a patient affirmation of tinnitus greater than 12 months
- •MML >= 7 dB (decibel)
- •Have tinnitus score of 40 or greater on the Tinnitus Handicap Questionnaire; (THQ)
- •No tinnitus treatment for at least 4 weeks prior to study entry.
- •Willing and able to understand and comply with all study-related procedures during the course of the study
排除标准
- •Acute or intermittent tinnitus
- •Severe hearing loss in any ear, as defined as more than an 80 dB HL (decibels hearing level) at frequencies from 250 Hz. to 8,000 Hz.
- •Meniere's disease, ear tumors, or evidence of active middle ear disease (such as fluid, infection, tumor, mass)
- •Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug
- •Pregnant or plan on becoming pregnant or breastfeeding during the study period
- •Currently require, or likely to require, MRI or diathermy during the study duration
- •History of adverse reactions to anesthetics (e.g., lidocaine) that in the Investigator's opinion make surgery too risky
- •Beck Depression Inventory (BDI) of 30 or greater
- •Any other form of tinnitus treatments (e.g. Herbal medication, acupuncture or chiropractic medicine) are not allowed during the study.
- •Any drug known to mimic, increase or decrease release or removal of a diffuse neuromodulator, such as norepinephrine, dopamine, serotonin, benzodiazepines, and acetylcholine is not allowed, as well as any psychoactive medications.
- •Significant cardiac history
- •Use of any medication known to cause or increase tinnitus, such as NSAIDS (ibuprofen, naproxen, nabumetone, etc.), aspirin and other salicylates, furosemide (Lasix) and other "loop" diuretics, "mycin" antibiotics such as vancomycin, quinine and related drugs, and chemotherapy agents such as cisplatin.
- •Involvement in litigation (e.g., worker's compensation claim and/or receiving disability benefits related to tinnitus and/or hearing loss).
研究组 & 干预措施
VNS Treatment
Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.
干预措施: VNS Treatment (Device)
VNS Control
Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.
干预措施: VNS Control (Device)
结局指标
主要结局
Number of Participants With Serious Adverse Events
时间窗: 6-weeks
Assess the number of serious adverse events during the study, and compare between groups to indicate if there are more in the treatment group than the control group.
次要结局
- Change in Tinnitus Handicap Questionnaire (THQ)(6-weeks (pre-implant to after 6-weeks of VNS))
- Change in Minimum Masking Level (MML) in Units of dB (Decibels)(6-weeks (pre-implant to after 6-weeks of VNS))
- Number of Participants With Adverse Events(6-weeks)
- Percent Change in Tinnitus Handicap Inventory (THI)(6-weeks (pre-implant to after 6-weeks of VNS))