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临床试验/NCT02648542
NCT02648542已完成不适用

The Effects of Compensatory Auditory Stimulation and Transcranial Direct Current Stimulation on Tinnitus Perception

Soterix Medical0 个研究点目标入组 17 人开始时间: 2013年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
主要终点
Reduction in minimum masking levels

研究概览

简要总结

This study evaluates the ability of compensatory auditory stimulation (CAS) and transcranial direct current stimulation (tDCS) to help alleviate tinnitus. Subjects will receive CAS, tDCS, and the combination of the two to assess the effectiveness of the treatment.

详细描述

Tinnitus refers to persistent "ringing in the ears" in absence of external sound. For some individuals tinnitus can be disabling. Most tinnitus is of idiopathic origin and currently there are no reliable treatment options available. Existing approaches, such as hearing aids, counseling, and noise masking typically provide only partial relief and only for a minority of patients. Newer exploratory methods include tailored auditory stimulation and various brain stimulation techniques. While these techniques show great promise in a subset of subjects (maybe about 1/3), it is hard to anticipate which, if any, will benefit a given patient.

Transcranial Direct Current Stimulation (tDCS) has been explored for a number of neurological conditions, and it is most effective when paired with some form of training (e.g. motor rehab after stroke). For tinnitus however this treatment modality has only been tested in isolation. The purpose of this pilot study is to explore the benefits of combining tailored compensatory auditory stimulation with tDCS.

There is widespread consensus in the research community that tinnitus originates with some peripheral hearing deficit, and that maladaptive central plastic mechanisms subsequently lead to the tinnitus percept. Most individuals with tinnitus have audiometric evidence of hearing loss. Our hypothesis is that reduced input to the auditory pathway leads to increased sensitivity (auditory gain) and finally aberrant activity in the frequency band with hearing loss. In this view, auditory stimulation that compensates for the reduced input can potentially revert the maladaptive plasticity.This is consistent with the reported benefits of hearing aids and tailored auditory stimulation. Our hypothesis is that tDCS can boost adaptation induced by compensatory auditory stimulation to reduce the strength of the phantom percept.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between 18-80 years of age
  • No history of otological disease
  • Subjects with hearing loss, hyperacusis and/or tinnitus are eligible to participate

排除标准

  • hearing loss greater than 50 dB HL
  • Shows signs of depression or anxiety (Zung self-rating Depression Scale > 50; Beck Anxiety Inventory > 36)

研究组 & 干预措施

CAS vs. tDCS

Active Comparator

Assess the efficacy of compensatory auditory stimulation (CAS) versus transcranial direct current stimulation (tDCS)

干预措施: Compensatory auditory stimulation (Other)

CAS vs. tDCS

Active Comparator

Assess the efficacy of compensatory auditory stimulation (CAS) versus transcranial direct current stimulation (tDCS)

干预措施: transcranial direct current stimulation (Device)

Combined CAS+tDCS vs. Sham

Sham Comparator

Assess the efficacy of combined compensatory auditory stimulation (CAS) + transcranial direct current stimulation (tDCS) versus sham stimulation

干预措施: Combined CAS and tDCS (Other)

Combined CAS+tDCS vs. Sham

Sham Comparator

Assess the efficacy of combined compensatory auditory stimulation (CAS) + transcranial direct current stimulation (tDCS) versus sham stimulation

干预措施: Sham stimulation (Other)

结局指标

主要结局

Reduction in minimum masking levels

时间窗: 2 weeks

Measurement of the minimum masking level required to mask the subjective tinnitus loudness is assessed after each intervention.

Reduction in tinnitus percept as assessed via the visual analog test of tinnitus loudness

时间窗: 2 weeks

Measurement of the subjective loudness of the tinnitus percept is measured using the visual analog scale test after each intervention.

次要结局

未报告次要终点

研究者

发起方
Soterix Medical
申办方类型
Industry
责任方
Sponsor

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