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临床试验/NCT04934371
NCT04934371尚未招募不适用

Treatment of Tinnitus With Noninvasive Neuromodulation and Listening Therapy: A Double-blind, Sham-controlled, Crossover Study

University of Arizona2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
2
主要终点
mean change on the Tinnitus Functional Index (TFI) scores

研究概览

简要总结

The goal of this study is to use non-invasive transcranial direct current stimulation (tDCS) combined with active listening therapy to treat tinnitus and hyperacusis and related conditions.

详细描述

Tinnitus is characterized by the subjective perception of sound in the ears or in the brain without external stimulus. In about 30-50% of patients, tinnitus co-occurs with hyperacusis, which is abnormal sensitivity to sounds even at low levels. Chronic tinnitus and hyperacusis can be devastating since a significant proportion of sufferers develop sleep disturbances, psychiatric conditions, and a small fraction commit suicide. Tinnitus is often accompanied by difficulty concentrating and impairment on tasks that require sustained attention and executive control. Currently there is no satisfactory treatment for tinnitus and hyperacusis, contributing to patients' distress. Thus, there is an urgent need for interventions that would suppress the symptoms and possibly cure the disorder. Although, the pathophysiology of tinnitus and hyperacusis is not well understood, neurobiological research suggests that tinnitus and hyperacusis can be attributed to maladaptive neuroplasticity triggered by damage in the auditory system. Most symptoms of tinnitus have been attributed to the hyperactivity and reorganization in the auditory cortex (AC) and dorsolateral prefrontal brain regions (DLPFC). This suggests that electrical stimulation to the abnormally activated regions might modulate these overactive regions and reduce tinnitus and hyperacusis. TDCS is a noninvasive neurostimulation technique that uses weak electric currents (1-2 mA) applied to the scalp to modulate brain responsiveness by temporarily altering neuronal resting membrane potentials. It is proposed that this approach has a potential therapeutic value in treating tinnitus and hyperacusis.

Our proposed project examines whether application of tDCS to AC and DLPFC combined with active listening therapy serves to promote adaptive neuroplasticity and reduce subjective perception of sound and emotional distress.

The Aims are to: (1) Determine whether tDCS can lead to significant improvement in tinnitus and hyperacusis symptoms pre- versus post-stimulation and

(2) Examine electrophysiological responses and functional connectivity in the fronto-temporal-parietal network of brain regions in response to tDCS vs. sham.

The expected outcomes from this research will provide evidence to support the design and implementation of individualized tDCS protocols to potentiate treatment protocols that address the core deficits in tinnitus and hyperacusis. Our data will contribute to a more detailed understanding of the neurobiology of tinnitus and the mechanisms that contribute to the subjective, emotional and cognitive symptoms. The results of our study have a potential to develop effective treatment for the rehabilitation of tinnitus and contribute to the clinical practice.

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
Triple (Participant, Care Provider, Investigator)

盲法说明

All audiological evaluations and tinnitus questionnaires performed before and after treatment will be carried out by trained personnel blind to the treatment condition. The neuroConn DC stimulator has a "study mode" where input codes will be used (the researcher and the participants will be blinded to these codes) and the settings generated will be either a sham or actual stimulation

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

  • chronic tinnitus and or hyperacusis (> 8 months)
  • adults (18-80 years old)

排除标准

  • implanted metal or devices including cochlear implants,
  • bullet wounds, head/neck tattoo,
  • metal in the eyes,
  • other diagnosed neurological disorders (e.g., stroke, Parkinson's, dementia, brain tumors),
  • head trauma or brain surgery, psychiatric disorders,
  • personal or family history of epilepsy, other seizure disorders
  • Individuals with a history of Meniere's Disease, pulsatile tinnitus, otosclerosis, and
  • chronic headaches.
  • conductive hearing loss, or
  • fluctuating hearing thresholds
  • pure tone averages >70dB HL

结局指标

主要结局

mean change on the Tinnitus Functional Index (TFI) scores

时间窗: through study completion, an average of 1 year

change in the tinnitus perception on a scale 0-10 (Max = 10: higher score indicates greater impairment)

Mean change in tinnitus severity and annoyance on the tinnitus hearing survey (THS)

时间窗: through study completion, an average of 1 year

change in participants' perception of tinnitus severity on a 0-4 numeric scale compared pre vs. post intervention (Max = 4; higher score indicates more severe tinnitus)

Mean change in tinnitus and hyperacusis ratings on the Visual Analog Scale

时间窗: through study completion, an average of 1 year

participants' rating on the Visual Analog Scale pre vs. post treatment (0-10), higher scores indicate greater impairment

Mean change in the Sound Tolerance Questionnaire ratings

时间窗: through study completion, an average of 1 year

change in the hyper-sensitivity to sound on a scale 0-10 (Max =10, higher score indicates greater sensitivity)

mean change on the Tinnitus Primary Function Questionnaire (TPFQ)

时间窗: through study completion, an average of 1 year

change in the tinnitus perception (score: 0-10; higher score indicates more severe tinnitus)

次要结局

  • change in electrophysiological measures(through study completion, an average of 1 year)
  • change in functional connectivity measured with fMRI(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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