The Effect of the Combined Treatment Approach of Delayed Auditory Feedback and Transcranial Direct Current Stimulation to Enhancement of Speech Fluency in Adults Who Stutter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean score of percentage of Stuttered Syllables produced in the speech sample
研究概览
简要总结
The aim of this study is to determine the effectiveness of concurrent transcranial direct current stimulation (tDCS) and fluency training in adults with developmental stuttering. We examine the severity of stuttering to investigate the effect of treatnment. In the control group the anodal tDCS and DAF will applied on six consecutive days (1 milliampere [mA] for 20 mins per day), and the control group will received the sham stimulation and DAF for the same time. The severity of stuttering measured by means of tasks and questionnaires before and after treatment sessions and 6 weeks after intervention.
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)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of developmental stuttering
- •Participants diagnosed with moderate to severe stuttering
- •Right handed
- •Native speaker of Farsi
排除标准
- •Speech or language disorders other than stuttering
- •Received stuttering treatment within the past year
- •Hearing loss
- •History of neurological or psychiatric disorders
- •History of seizure
- •Taking any medication that may affect brain function such as anti-depressants
研究组 & 干预措施
Experimental
Participants will receive one anodal tDCS at 1 mA intensity over the left superior temporal gyrus (T3 in 10-20 international system) and the cathode tDCS over the right orbitofrontal area (Fp2 in 10-20 international system). tDCS will be delivered for 20 minutes during fluency intervention for six consecutive days.
干预措施: Anodal tDCS (Device)
Experimental
Participants will receive one anodal tDCS at 1 mA intensity over the left superior temporal gyrus (T3 in 10-20 international system) and the cathode tDCS over the right orbitofrontal area (Fp2 in 10-20 international system). tDCS will be delivered for 20 minutes during fluency intervention for six consecutive days.
干预措施: fluency intervention/ Delayed Auditory Feedback (Behavioral)
Sham Comparator
Participants will receive sham tDCS while the one anode electrode will be positioned over the left superior temporal gyrus and the cathode will be placed over the right orbitofrontal similar to the active mode. The sham stimulation will break down after 30 seconds at the beginning of 20 minutes of fluency intervention for six consecutive days.
干预措施: fluency intervention/ Delayed Auditory Feedback (Behavioral)
Sham Comparator
Participants will receive sham tDCS while the one anode electrode will be positioned over the left superior temporal gyrus and the cathode will be placed over the right orbitofrontal similar to the active mode. The sham stimulation will break down after 30 seconds at the beginning of 20 minutes of fluency intervention for six consecutive days.
干预措施: Sham tDCS (Device)
结局指标
主要结局
Mean score of percentage of Stuttered Syllables produced in the speech sample
时间窗: Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment
Researcher will calculate the Percentage of Stuttered Syllables (SS %) in the speech sample. Lower percentage of Stuttered Syllables represents better outcomes.
次要结局
- Mean score of the Stuttering Severity Instrument version 4 (SSI-4)(Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment)
- Mean score of the Overall Assessment of Speakers Experience of Stuttering (OASES)(Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment)
研究者
Moin
Principal Investigator
Iran University of Medical Sciences