Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change in PET Asymmetry Index
研究概览
简要总结
One out of every five people experience tinnitus (a buzzing, ringing, or roaring sound in the ear) ranging from mild to severe impairment. To date there is no effective therapy that seems to help the tinnitus sufferer. The purpose of this study is to develop a therapy using a technique called Repetitive Transcranial Magnetic Stimulation (rTMS) to hopefully alleviate or reduce the symptoms of tinnitus.
This research is being conducted at the University of Arkansas for Medical Sciences (UAMS). Up to twenty (20) right handed subjects, either males or females, 19-65 years of age, with tinnitus that is severe enough for those persons to seek medical attention will have been seen as patients in the UAMS Hearing and Balance Center, where routine testing includes a physical exam, hearing tests, evaluation of middle ear status, and an MRI scan (a machine that acquires visual images of the brain). A diagnosis of tinnitus will be established after ruling out all other possible causes of the tinnitus.
详细描述
Subjects will be up to 20 right-handed patients (men and women), 19-65 years of age, with debilitating unilateral or bilateral tinnitus. All subjects must report experiencing the presence of their phantom auditory perception for at least 6 months and have a Tinnitus Handicap Questionnaire (THQ) score >30. Subjects will be recruited from the Otolaryngology Clinic at UAMS, where routine testing includes a physical exam; pure tone audiometry; and evaluation of middle ear status using tympanometry, stapedius reflex tests, and otoscopy. Patients will undergo a gadolinium-contrast MRI of the head to rule out acoustic neuroma or any other central nervous system pathology. All subjects will be thoroughly informed of the risks associated with the procedures in this study, as described in the Hazards to Subjects section, and written informed consent will be obtained. Subjects will be recruited for this study without regard to race or ethnicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •right-handed subjects
- •19-65 years of age
- •debilitating unilaterial or bilateral tinnitus
- •Experiencing the presence of phantom auditory preception for >6 months
- •Tinnitus Handicap Questionnaire score of >30
排除标准
- •significant neurological disease
- •acoustic neuromas or glomus tumors
- •active Meniere's disease
- •profound hearing loss
- •non English speaking
- •personal or family history of epilepsy
- •personal history of head injury, aneurysm, stroke, previous cranial neurosurgery, neurological or psychiatric disorders, metal implants in the head or neck, a pacemaker, pregnancy, migraines,
- •medications that lower seizure threshold and are contraindicated
- •individuals who have been taking certain medications
- •claustrophobia
- •patients who do not exhibit significant cortical asymmetries on PET
结局指标
主要结局
Change in PET Asymmetry Index
时间窗: After active treatment week
Change in calculated PET asymmetry index between left and right temporal lobe from baseline following active Tx
次要结局
- Difference in Visual Analog Rating of Tinnitus (VAR)Following Active and Sham Tx(immediately following active and sham TMS)
- Psychomotor Vigilance(Immediately after treatment)