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临床试验/NCT04036630
NCT04036630招募中不适用

Enhancing Speech Intelligibility Using Transcranial Alternating Current Stimulation (tACS)

University of Zurich2 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
190
试验地点
2
主要终点
articulatory motor-evoked potential (aMEP) amplitude (Experiment 1) - time point 1

研究概览

简要总结

This study contributes to fundamental research investigating the role of the articulatory-motor integration and cerebro-acoustic coherence in speech comprehension. In a series of experiments non-invasive brain stimulation (NIBS) techniques including transcranial electric stimulation with alternating current waveforms (tACS) and transcranial magnetic stimulation (TMS) will be applied to the left ventral motor cortex (vMC) to test the contribution of this area to speech comprehension under challenging listening situations. As long as the exclusion criteria for TMS and tACS are strictly considered, only very minimal risks and no long-term effects are expected.

There are no known risks associated with NIBS and pregnancy; however, since risks cannot be completely excluded, pregnant women will be excluded from participation. If a female participant is uncertain whether she is pregnant, she will be provided with a pregnancy test at no cost.

详细描述

Background and Rationale In Europe, 71 million people - 16% of the population - suffer from hearing difficulties. One of the major consequences of hearing impairment is reduced speech-comprehension ability, especially in acoustically challenging conditions such as in reverberant or noisy environments.

The proposed project is intended to develop our understanding of the mechanisms that can be exploited to support speech comprehension under challenging listening conditions, and how they can be enhanced in hearing-impaired and older listeners.

To this end, the compensatory neural mechanisms of articulatory-motor integration will be tested by applying transcranial alternating current stimulation (tACS) over the vMC.

Objective(s) The overall objective of the study is to shed light on the compensatory mechanisms supporting speech comprehension under perceptually-challenging conditions.

Experiment 1 to 3 The primary objective is to test the utility of auditory-motor integration for degraded speech (DS) comprehension.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

single-blind

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

  • Written informed consent by the participant
  • Age: 18-35 / 65+
  • Normal (or corrected to normal) vision
  • German as a first language
  • Right-handed

排除标准

  • hearing loss
  • Raised bi- or multilingual
  • Women who are currently pregnant or breastfeeding
  • Known or suspected drug or alcohol abuse
  • History of brain injury or any neurological disorder (y/n)
  • For example, stroke, traumatic brain injury, brain surgery, epilepsy etc.
  • History of psychiatric disorder
  • Recent drug consumption
  • Medication with cognitive side effects (e.g. psychoactive medications or sleeping pills)
  • Metallic implants in the head region (excluding fixed braces and tooth fillings)
  • Any implanted medical device (e.g. cardiac pacemakers)
  • previous enrolment in one of the experiments comprising the main investigational plan

结局指标

主要结局

articulatory motor-evoked potential (aMEP) amplitude (Experiment 1) - time point 1

时间窗: online (during tACS intervention)

The comparison of articulatory motor-evoked potential (aMEP) amplitude after tACS and sham stimulation

degraded speech comprehension (Experiment 3)

时间窗: 20min after tACS or sham stimulation (between-group design), following a training of degraded speech comprehension

Subjects will listen and transcribe noise-vocoded sentence according to their subjective intelligibility levels (75% (easy), 50% (medium) and 25% (difficult)) assessed prior to the expermental manipulation Comparison of degraded speech comprehension following tACS over the left ventral motor cortex (vMC) with performance following sham stimulation over the same region.

articulatory motor-evoked potential (aMEP) amplitude (Experiment 1) - time point 3

时间窗: 55min after (tACS)

The comparison of articulatory motor-evoked potential (aMEP) amplitude after tACS and sham stimulation

degraded speech comprehension (Experiment 2)

时间窗: right after tACS or sham stimulation (cross-over design)

Subjects will listen and transcribe noise-vocoded sentence according to their subjective intelligibility levels (75% (easy), 50% (medium) and 25% (difficult)) assessed prior to the expermental manipulation Comparison of degraded speech comprehension following tACS over the left ventral motor cortex (vMC) with performance following sham stimulation over the same region.

degraded speech comprehension (Experiment 4)

时间窗: during env-tACS or sham stimulation (online)

Subjects will listen and transcribe noise-vocoded sentence according to their subjective intelligibility levels (75% (easy), 50% (medium) and 25% (difficult)) assessed prior to the expermental manipulation The comparison of degraded speech comprehension between concomitant low-frequency (theta-band) speech envelope-shaped tACS (env-tACS), reversed env-tACS, and sham stimulation over left ventral motor cortex

articulatory motor-evoked potential (aMEP) amplitude (Experiment 1) - time point 2

时间窗: 5min after tACS

The comparison of articulatory motor-evoked potential (aMEP) amplitude after tACS and sham stimulation

次要结局

  • speech degradation level (Experiment 2)(right after tACS or sham stimulation (cross-over design))
  • syllable discrimination ability (Experiment 1) - time point 2(5min after tACS or sham stimulation (cross-over design))
  • syllable discrimination ability (Experiment 1) - time point 1(before tACS or sham stimulation (cross-over design))
  • word length (Experiment 4)(during env-tACS or sham stimulation (online))
  • age group dependent tACS modulation (Experiment 3)(20min after tACS or sham stimulation (between-group design), following a training of degraded speech comprehension)
  • age group dependent tACS modulation (Experiment 2)(right after tACS or sham stimulation (cross-over design))
  • speech degradation level (Experiment 3)(20min after tACS or sham stimulation, following a training of degraded speech comprehension)
  • tACS-auditory stimulus timing (Experiment 4)(during env-tACS)
  • age group dependent tACS modulation (Experiment 4)(during env-tACS, reversed env-tACS or sham stimulation (online))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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