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临床试验/NCT05574803
NCT05574803已完成不适用

Using High-definition Transcranial Direct Current Stimulation to Improve Speech Fluency in Cantonese-speaking Adults Who Stutter - A Preliminary Investigation

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年7月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Stuttering severity [Severity rating (SR)]

研究概览

简要总结

The proposed study aims to investigate the effect of combined transcranial direct current stimulation (tDCS) and behavioural speech training in improving speech fluency in Cantonese-speaking adults who stutter (AWS), and to examine its maintenance over a 6-week period.

详细描述

The proposed study aims to

  1. assess the effect of multiple sessions of tDCS over the supplementary motor area (SMA) combined with behavioural speech training on stuttering recovery in terms of a reduction of stuttering severity and increased speech satisfaction in Cantonese-speaking AWS;
  2. investigate the maintenance of combined tDCS-behavioural speech training effects on speech fluency and speech satisfaction in Cantonese-speaking AWS over a 6-week period.

Twenty Cantonese-speaking AWS will be randomly assigned to an experimental group and a control group. Both groups will receive behavioral treatment for stuttering, including the speech prolongation technique, for five sessions. Concurrent with behavioural training, the experimental group will receive anodal tDCS (1 mA for 20 minutes), while the control group will receive sham tDCS (1 mA for one minute), over the SMA. Stuttering severity and speech satisfaction will be assessed independently before, immediately after, one week and six weeks after treatment. It is anticipated that AWS will experience reduction in their stuttering severity after stimulation, and the improvement will be maintained for a longer period as compared with receiving behavioural treatment alone.

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
Triple (Participant, 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

入选标准

  • Demonstrated features of stuttering;
  • More than 2% of syllables stuttered over three baseline speech samples, as measured by qualified speech therapists.

排除标准

  • Personal or family history of epilepsy or seizures
  • History of a neurological condition
  • Speech disorders
  • Hearing impairment
  • Metallic foreign body implant
  • On medications that lower neural thresholds (e.g. tricyclines, antidepressants, neuroleptic agents, etc.)
  • Had speech therapy for stuttering in the past four months

结局指标

主要结局

Stuttering severity [Severity rating (SR)]

时间窗: Change before, immediately after, one week and six weeks after treatment

The subjects will be trained to rate their own stuttering severity based on a 9-point SR scale, with 0 = no stuttering, 1 =very mild stuttering, and 8 = the most severe stuttering.

Stuttering severity [Percent syllables stuttered (%SS)]

时间窗: Change before, immediately after, one week and six weeks after treatment

%SS is based on the proportion of spoken syllables that a judge perceives to be stuttered. It will be measured by a qualified speech therapist with prior training in stuttering assessment in Cantonese who will be blinded to the treatment conditions. To establish inter-rater agreement, 20% of the speech samples across different assessment data points will be randomly selected and rated by a second speech therapist.

次要结局

  • Subject satisfaction(One week and six weeks after treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Min Wong

Assistant Professor

The Hong Kong Polytechnic University

研究点 (1)

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