IMPACT OF TRANSCRANIAL DIRECT CURRENT STIMULATION ON THE STANDARDS OF CEREBRAL ELECTRIC ACTIVITY IN PATIENTS WITH CHRONIC TINNITUS: CLINICAL TRIAL, DOUBLE BLIND, PLACEBO-CONTROLLED
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Tinnitus Handicap Inventory
研究概览
简要总结
Relating the electroencephalogram findings of patients with tinnitus before and after a therapeutic modality is still scarce in the literature, especially with neuromodulatory methods, more specifically with Transcranial Direct Current Stimulation - tDCS. This study is a double blind, sham-controlled clinical trial aiming investigate the impact of tDCS on patterns of brain electrical activity in patients with chronic tinnitus. 36 volunteers with tinnitus will be allocated randomly in 2 groups: the first (n = 18) will receive anodic tDCS in the temporoparietal left area and cathode in the right dorsolateral prefrontal cortex and the second group (n = 18) correspond to the sham group. In addition, healthy individuals (n = 18) will be recruited for comparative purposes of brain electrical activity with and without tinnitus, totaling 54 participants. Patients with tinnitus will receive transcranial direct current stimulation for 20 minutes for 5 consecutive days (1 week) and will be assessed before and after intervention by electroencephalogram, Acuphenometry, Visual Analogue Scale - VAS and questionnaire Tinnitus Handicap Inventory- THI. Follow-up of volunteers will also be performed after 1 month of the end of treatment with tDCS.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of at least 18 years;
- •Chronic tinnitus for at least 6 months.
- •Age-adjusted normal (sensorineural) hearing
排除标准
- •Pregnancy and/or lactation;
- •Concurrent treatment for tinnitus;
- •Prior exposure to transcranial direct current stimulation (tDCS);
- •History of epilepsy and/or seizures;
- •Electronic implants or metallic objects in body;
- •Skin conditions where electrodes will be applied;
- •Major neurological co-morbidities.
结局指标
主要结局
Tinnitus Handicap Inventory
时间窗: THI will be measured before intervention (baseline), after 5 daily sessions (day 5) and 1 month after the last intervention.
Assesses change in tinnitus from baseline to follow-up periods post interventions
次要结局
- Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress(Visual analogue scale of tinnitus wiil be recorded at baseline (before intervention), before and after daily sessions with tDCS (day 1 to 5) , and 1 month after the last intervention.)
- Acuphenometry(Acufhenometry wiil be recorded at baseline (before intervention), before and after daily sessions with tDCS (day 1 to 5) , and 1 month after the last intervention.)
研究者
Dayse da Silva Souza
Principal Investigator
Federal University of Paraíba