Venous Sinus Stenting To Treat Intractable Pulsatile Tinnitus Caused By Venous Sinus Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Patients With Complete or Near-complete Resolution of Tinnitus
研究概览
简要总结
There have been few published studies that examine the efficacy and safety of endovascular treatments on patients with pulsatile tinnitus with venous stenosis. Despite the limited experience with venous sinus stenting to treat pulsatile tinnitus, preliminary results show that venous sinus stenting could represent a viable alternative for refractory pulsatile tinnitus patients with venous sinus stenosis. The purpose of this study is to evaluate the safety and efficacy of this procedure in a controlled fashion, using strict inclusion and exclusion criteria, and long-term clinical and imaging follow-up. The investigators hope to provide robust data regarding the safety and efficacy of venous sinus stenting for patients with pulsatile tinnitus.
详细描述
WHAT IS INVOLVED IN THE STUDY?
A. Screening process - not experimental:
Patients with pulsatile tinnitus, evidence of narrowing of the large veins of the brain, and failure of prior conservative treatment will be considered for enrollment. All patients will undergo the standard of care evaluation for tinnitus by a specialist physician for diseases of the ear (Ear, Nose and Throat [ENT] physician or otorhinolaryngologist). If it is determined that the narrowing of the large veins of the brain ("dural venous sinuses") is the most likely etiology for the tinnitus, then the possibility of enrollment in the trial will be discussed. Imaging studies of the head and temporal bone will be performed in order to further confirm venous sinus stenosis as the etiology of the pulsatile tinnitus and to rule out other possible causes. Additionally, patients will answer the questions listed on the Tinnitus Handicap Inventory questionnaire.
During the screening process, investigators will review the results of tests that are not experimental and are performed as part of participants' routine care. In other words, these tests are performed regardless of participation in the study and are termed "standard procedures".
B. Participating in the study:
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
- •Severe or catastrophic venous pulsatile tinnitus defined as Grades 4 or 5 on Tinnitus Handicap Inventory
- •50% or more stenosis of the lateral venous sinus on Magnetic Resonance Venogram (MRV) or Computed Tomographic Venogram (CTV_, ipsilateral to the side of more severe tinnitus
- •Failure of conservative or non-surgical therapies (including sound therapy, sound masking, hearing aids, tinnitus retraining (desensitization) therapy. Failure is defined as Grades 4 or 5 on the Tinnitus Handicap Inventory despite prior treatments that have lasted for at least 3 months.
排除标准
- •Non-pulsatile tinnitus
- •Contra-indication to iodinated contrast
- •Contra-indication to antiplatelet therapy
- •Contra-indication to general anesthesia
- •Pregnancy or plans for immediate pregnancy
结局指标
主要结局
Number of Patients With Complete or Near-complete Resolution of Tinnitus
时间窗: 12 months
Tinnitus will be measured by: No, slight, mild, or moderate (Grades 1, 2, and 3) on Tinnitus Handicap Inventory.
Change in Number of Patients With Improvement of More Than One Grade in the Tinnitus Handicap Inventory Questionnaire
时间窗: 1, 6, 12, and 24 months after stent placement.
Tinnitus will be measured by: No, slight, mild, or moderate (Grades 1, 2, and 3) on Tinnitus Handicap Inventory.
次要结局
- Number of Subjects With Long-term Patency of the Stent(12 months)
- Number of Adverse Events Probably or Possibly Related to the Treatment(24 months)
- Number of Severe Adverse Events Probably or Possibly Related to the Treatment(24 months)
- Number of Subjects With Clinical Recurrence of Their Tinnitus(24 months)