Moein Narges, Mohamadi Reyhane, Rostami Reza, Nitsche Michael, Zomorrodi Reza, Ostadi Amir, Keshtkar Abbasali
Department of Speech and Language Pathology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.
Rehabilitation Research Center, Iran University of Medical Sciences, Tehran, Iran.
JMIR Res Protoc. 2020 Apr 21;9(4):e16646. doi: 10.2196/16646.
Stuttering is a complex speech disorder that affects speech fluency. Recently, it has been shown that noninvasive brain stimulation may be useful to enhance the results of fluency interventions in adults who stutter. Delayed auditory feedback (DAF) is a method to enhance speech fluency in individuals who stutter. Adjunctive interventions are warranted to enhance the efficacy of this intervention.
Individuals who stutter have pathological activation patterns in the primary and secondary auditory areas. Consequently, in this study, we hypothesize that stimulation of these areas might be promising as an adjunctive method to fluency training via DAF to enhance speech therapy success in individuals with a stutter. We will systematically test this hypothesis in this study.
This study is designed as a randomized, double-blind, sham-controlled clinical trial. All participants will receive DAF. The intervention group will additionally receive real transcranial direct current stimulation, while the control group will be exposed to sham stimulation. The assignment of the participants to one of these groups will be randomized. Before starting the treatment program, 2 preintervention assessments will be conducted to determine the severity of stuttering. Once these assessments are completed, each subject will participate in 6 intervention sessions. Postintervention assessments will be carried out immediately and 1 week after the last intervention session. Subsequently, to explore the long-term stability of the treatment results, the outcome parameters will be obtained in follow-up assessments 6 weeks after the treatment. The primary outcome measurement-the percentage of stuttered syllables-will be calculated in pre-, post-, and follow-up assessments; the secondary outcomes will be the scores of the following questionnaires: the Stuttering Severity Instrument-Fourth Edition and the Overall Assessment of the Speaker's Experience of Stuttering.
This protocol was funded in 2019 and approved by the Research Ethics Committee of the Iran University of Medical Sciences in June 2019. Data collection started in October 2019. As of February 2020, we have enrolled 30 participants. We expect data analysis to be completed in April 2020, and results will be published in summer 2020.
We anticipate that this study will show an adjunctive effect of transcranial direct current stimulation, when combined with DAF, on stuttering. This should include not only a reduction in the percentage of stuttered syllables but also improved physical behavior and quality of life in adults who stutter.
ClinicalTrial.gov NCT03990168; https://clinicaltrials.gov/ct2/show/NCT03990168.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16646.
口吃是一种影响言语流畅性的复杂言语障碍。最近的研究表明，无创脑刺激可能有助于提高口吃成年人流畅性干预的效果。延迟听觉反馈（DAF）是一种提高口吃者言语流畅性的方法。辅助干预措施有助于提高这种干预的效果。
口吃者在初级和次级听觉区域存在病理激活模式。因此，在本研究中，我们假设刺激这些区域作为通过DAF进行流畅性训练的辅助方法，可能有助于提高口吃者言语治疗的成功率。我们将在本研究中系统地验证这一假设。
本研究设计为一项随机、双盲、假刺激对照的临床试验。所有参与者都将接受DAF。干预组还将接受真正的经颅直流电刺激，而对照组将接受假刺激。参与者被随机分配到其中一组。在开始治疗方案之前，将进行2次干预前评估以确定口吃的严重程度。这些评估完成后，每个受试者将参加6次干预疗程。干预后评估将在最后一次干预疗程后立即进行，并在1周后进行。随后，为了探索治疗结果的长期稳定性，将在治疗后6周的随访评估中获取结果参数。主要结局指标——口吃音节的百分比——将在干预前、干预后和随访评估中进行计算；次要结局指标将是以下问卷的得分：口吃严重程度量表第四版和口吃者总体体验评估量表。
该方案于2019年获得资助，并于2019年6月获得伊朗医科大学研究伦理委员会的批准。数据收集于2019年10月开始。截至2020年2月，我们已招募了30名参与者。我们预计数据分析将于2020年4月完成，结果将于2020年夏季发表。
我们预计本研究将表明，经颅直流电刺激与DAF联合使用对口吃具有辅助作用。这不仅应包括口吃音节百分比的降低，还应包括口吃成年人身体行为和生活质量的改善。
ClinicalTrial.gov NCT03990168；https://clinicaltrials.gov/ct2/show/NCT03990168。
国际注册报告识别码（IRRID）：DERR1-10.2196/16646。
