Investigating Non-invasive Brain Stimulation to Enhance Fluency in People Who Stutter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change in Stuttering Severity Instrument (SSI-4) Score
研究概览
简要总结
This study aims to test whether the application of transcranial direct current stimulation (tDCS) concurrent with fluency training results in improvements in speech fluency in adults with developmental stuttering, measured up to three months after the intervention.
详细描述
Developmental stuttering affects 5% of children and persists to adulthood in about 1%. Changing the way speech is produced in adults who stutter is a particular challenge for speech and language therapy and there is a need for novel interventions. One such intervention involves the application of transcranial direct current stimulation (tDCS) alongside therapies aimed at improving speech fluency. tDCS influences brain activity by modulating neuronal plasticity through the application of weak electrical currents across the brain. Pairing tDCS with speech therapy has potential for producing larger or longer lasting effects and reducing time spent in therapy.
The study will evaluate the potential of tDCS combined with speech fluency training to improve outcomes in people who stutter (PWS). PWS will have this training while receiving tDCS for five days (1 milliampere [mA] for 20 mins per day) in a double-blind randomized controlled trial. Outcomes will be measured in terms of changes to stuttering severity.
An additional research questions is how changes in interactions between sensory and motor brain regions relate to changes in speech fluency in PWS. MRI will be used to measure brain structure and function and the vocal tract during speech production. Transcranial magnetic stimulation (TMS) will assess motor excitability before and after the training.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A researcher from another research group who is not involved in any aspect of the trial will perform the randomisation of participants into the sham and tDCS study arms using a minimisation procedure within "randPack" package in R (Carey and Gentleman, 2016). Allocation concealment will be achieved by assigning a unique 5-digit code per participant (containing no identifying information regarding trial arm). This will be emailed to the researcher. The code is used to deliver stimulation via study mode on the stimulator (http://www.neurocaregroup.com/dc_stimulator_plus.html). The participants and the researchers who will deliver the intervention, assess the outcomes, and analyse the data will be masked to trial arm.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Diagnosed with developmental stuttering of mild-moderate or greater severity
- •Native speaker of English
- •Normal or corrected-to-normal vision
- •Normal hearing
排除标准
- •Speech, language or communication disorder other than developmental stuttering.
- •Contraindication to brain stimulation (tDCS or TMS)
- •Contraindication to MRI
- •History of drug abuse
- •History of a neurological or psychiatric illness
- •Any previous neurosurgical procedures
- •Taking prescription or over-the-counter medication that may affect brain function (for example, anti-depressants)
- •Family history of epilepsy (first degree relative)
- •Severe claustrophobia (as they may be unable to tolerate scanner)
结局指标
主要结局
Change in Stuttering Severity Instrument (SSI-4) Score
时间窗: 1 week, 6 weeks and 12 weeks after the end of the 5-day intervention
The Stuttering Severity Instrument (SSI-4) is a standardised measure of stuttering severity comprised of 3 sub-scores (frequency, duration and physical concomitants) which are summed to give a total score. We will use change from baseline in total score (i.e. baseline subtracted) on the Stuttering Severity Instrument version 4 measured post intervention. The maximum total score of the SSI-4 is 56, which corresponds to the highest stuttering severity. Therefore, larger negative change scores represent better outcomes (larger reductions in stuttering severity).
次要结局
- Change in percentage of disfluent syllables produced during conversation(1 week, 6 weeks and 12 weeks after the end of the 5-day intervention)
- Change in percentage of disfluent syllables produced during reading(1 week, 6 weeks and 12 weeks after the end of the 5-day intervention)
- Change in Overall Assessment of the Speaker's Experience of Stuttering (OASES) score(6 weeks and 12 weeks after the end of the 5-day intervention)