Neuronavigated Transcranial Magnetic Stimulation As An Adjunctive Treatment For Chronic Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Tinnitus Handicap Inventory (THI)
研究概览
简要总结
This study is testing whether a special type of brain stimulation called neuronavigated TMS can help reduce tinnitus (ringing in the ears). 50 people with tinnitus will each receive 20 treatment sessions - 10 real treatments and 10 sham treatments in random order, with a 2-week break between them. Before starting, participants get an MRI brain scan to guide where the stimulation device is placed. Questionnaires of measuring tinnitus severity will be asked four times throughout the study to determine to check the effect of TMS on treating tinnitus.
详细描述
This study aims to investigate the beneficial effects of neuronavigated TMS (nTMS) in alleviating tinnitus symptoms and to establish safety and tolerability of nTMS in patients with tinnitus.
50 eligible subjects will be recruited and be randomized to receive 10 sessions of daily verum nTMS followed by 10 sessions of daily sham nTMS (verum-sham), or sham nTMS followed by verum nTMS (sham-verum). There will be a 2-week break between the two types of nTMS.
MRI will be conducted before the 1st session of nTMS for the TMS navigation system.
Outcome measures include Tinnitus Handicap Inventory (THI), Tinnitus Functional Index (TFI), and Tinnitus-Visual Analogue Scale (T-VAS). All assessment will be evaluated 4 times- before the 1st nTMS session, after the 10th nTMS session, before the 11th nTMS and after the 20th nTMS session.
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, Outcomes Assessor)
盲法说明
Assessor and participant will be blinded to the sequence of nTMS assigned to the subject.
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-80 years old;
- •Subjective tinnitus severity as per Tinnitus-Visual Analogue Scale of 1/10 and above (in any domain: sound, distress, Quality of Life)
排除标准
- •Any metal implants inside the body that are contraindications of MRI scan;
- •Cardiac pacemakers;
- •Epilepsy with recurrent seizures;
- •Cognitively impaired patients will be excluded;
- •Claustrophobia;
- •Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina;
- •Major depression and a history of psychotic disorders;
- •Terminal diagnosis with life expectancy <=1 year.
研究组 & 干预措施
real-sham
Subjects will receive 10 sessions of real nTMS, 5 times a week for 2 weeks, followed by 10 sessions of sham nTMS, 5 times a week for 2 weeks. There will be a 2-week break between the 2 types of nTMS.
干预措施: navigated rTMS (Device)
sham-real
Subjects will receive 10 sessions of sham nTMS, 5 times a week for 2 weeks, followed by 10 sessions of real nTMS, 5 times a week for 2 weeks. There will be a 2-week break between the 2 types of nTMS.
干预措施: navigated rTMS (Device)
结局指标
主要结局
Tinnitus Handicap Inventory (THI)
时间窗: Week 0
THI consists of a 25 items which evaluate the subjective burden of tinnitus under a three-response system: yes (score = 4), sometimes (score = 2), or no (score = 0). THI scores of 18-36 are considered as mild tinnitus, 38-56 are considered moderate, and 58-76 are considered severe, while 78-100 are considered catastrophic.
Tinnitus Handicap Inventory (THI)
时间窗: Week 3
THI consists of a 25 items which evaluate the subjective burden of tinnitus under a three-response system: yes (score = 4), sometimes (score = 2), or no (score = 0). THI scores of 18-36 are considered as mild tinnitus, 38-56 are considered moderate, and 58-76 are considered severe, while 78-100 are considered catastrophic.
Tinnitus Handicap Inventory (THI)
时间窗: Week 6
THI consists of a 25 items which evaluate the subjective burden of tinnitus under a three-response system: yes (score = 4), sometimes (score = 2), or no (score = 0). THI scores of 18-36 are considered as mild tinnitus, 38-56 are considered moderate, and 58-76 are considered severe, while 78-100 are considered catastrophic.
Tinnitus Handicap Inventory (THI)
时间窗: Week 7
THI consists of a 25 items which evaluate the subjective burden of tinnitus under a three-response system: yes (score = 4), sometimes (score = 2), or no (score = 0). THI scores of 18-36 are considered as mild tinnitus, 38-56 are considered moderate, and 58-76 are considered severe, while 78-100 are considered catastrophic.
次要结局
- Tinnitus Functional Index (TFI)(Week 0)
- Tinnitus Functional Index (TFI)(Week 3)
- Tinnitus Functional Index (TFI)(Week 6)
- Tinnitus Functional Index (TFI)(Week 7)
- Tinnitus-Visual Analogue Scale (T-VAS)(Week 0)
- Tinnitus-Visual Analogue Scale (T-VAS)(Week 3)
- Tinnitus-Visual Analogue Scale (T-VAS)(Week 6)
- Tinnitus-Visual Analogue Scale (T-VAS)(Week 7)