Non-Invasive Neuromodulation for Tinnitus Management: Comparative Evaluation of Transcutaneous Auricular Vagal Nerve Stimulation and Transcranial Direct Current Stimulation Modalities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1. Tinnitus severity: assessed using validated patient reported outcome measures (Tinnitus Handicap Inventory; Tinnitus Functional Index; VAS for tinnitus loudness, annoyance and distress; DASS; WHO quality of life index)
研究概览
简要总结
This interventional study aims to compare the efficacy of two non-invasive neuromodulation techniques i.e., transcutaneous auricular vagal nerve stimulation (taVNS) and transcranial direct current stimulation (tDCS) in managing chronic primary tinnitus. Participants will include adults with tinnitus (primary, subjective chronic ≥ 3 months duration) who will be allocated to either the taVNS or the tDCS group based on their treatment preference. Control group will include participants unwilling to receive neuromodulation but otherwise meeting the study criteria.
Assessment of tinnitus severity and impact on participant’s quality of life will be done using validated patient reported outcome measures at baseline, immediately post-intervention, and 3 months follow-up from baseline. Additionally, the participants shall perform standardised cognitive tasks at each assessment, to assess potential impact on cognition. The change in tinnitus severity and cognitive performance will be compared in the three participant groups. We hypothesize that both neuromodulation modalities taVNS and tDCS significantly reduce tinnitus severity when compared to the control group (not receiving neuromodulation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Tinnitus characteristics: Chronic (duration 3 months or more), subjective, non-pulsatile, primary, unilateral/bilateral, with or without SNHL
- •Normal otoscopic examination; No organic cause of tinnitus identified based on clinical assessment.
- •Willing to undergo the assigned treatment modality as per the study protocol.
- •4.Those not willing for neuromodulation, but meeting other criteria may be recruited as controls.
排除标准
- •Objective / pulsatile / synchronous tinnitus
- •Secondary tinnitus: External / middle ear pathology/ history of ear surgery/ trauma/ retro-cochlear neoplasm
- •Any associated neurological deficit except Sensori-neural hearing loss
- •History of neurosurgery, intracranial implant
- •Implanted cardiac pacemaker, cardioverter/defibrillator
- •Known cardiac condition; diagnosed neurological or clinical psychiatric disorder
- •Pregnancy
- •Previous treatment with taVNS, tDCS, TMS stimulation within the last six months.
结局指标
主要结局
1. Tinnitus severity: assessed using validated patient reported outcome measures (Tinnitus Handicap Inventory; Tinnitus Functional Index; VAS for tinnitus loudness, annoyance and distress; DASS; WHO quality of life index)
时间窗: 1. Baseline assessment (at the time of recruitment) | 2. At completion of 10 sessions of neuromodulation for the intervention groups and 4-6 weeks post- recruitment for control group. | 3. At 12 weeks (3 months) post baseline assessment
2. Reduction in scores from pre-treatment levels
时间窗: 1. Baseline assessment (at the time of recruitment) | 2. At completion of 10 sessions of neuromodulation for the intervention groups and 4-6 weeks post- recruitment for control group. | 3. At 12 weeks (3 months) post baseline assessment
次要结局
- 1. Performance in cognitive assessment tasks i.e., memory, executive and auditory processing.
研究者
Dr Garima Upreti
Department of Otorhinolaryngology, All India Institute of Medical Sciences, Rajkot