Stuttering and Neuromodulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in Stuttering Severity Instrument - 4th Edition (SSI-4) total score
研究概览
简要总结
The purpose of this study is to collect preliminary data on the efficacy of transcranial direct current stimulation (tDCS) combined with traditional behavioral techniques to reduce stuttering severity and negative impact in adults who stutter. The study also aims to explore neuroplastic changes (i.e., regional activation and functional connectivity) resulting from combined tDCS + speech therapy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 65 years.
- •Diagnosis of developmental stuttering, verified by a licensed speech-language pathologist.
- •Mild-to-moderate or greater stuttering severity, defined as a score of 20 or higher on the Stuttering Severity Instrument-Fourth Edition (SSI-4).
- •English as a primary language.
- •Right-handedness (to minimize variability in neural lateralization).
- •Willing and able to attend all study sessions and follow study procedures.
排除标准
- •Have a history of neurological, psychiatric, or medical conditions that are contraindicated for tDCS.
- •Are currently taking medications known to affect cortical excitability.
- •Have a history of seizures or epilepsy.
- •Are pregnant or planning to become pregnant during the study period.
- •Have metal implants in the head (excluding dental work) or other contraindications to electrical brain stimulation.
- •Any skin disorder or skin sensitive area near stimulation locations.
研究组 & 干预措施
Behavioral speech therapy combined with active tDCS
Each participant will complete ten treatment sessions over approximately ten weeks. In each session, participants will receive active tDCS for 30 minutes while concurrently engaging in behavioral speech therapy. Active stimulation will include a 30-second ramp-up to 2.0 mA, 30 minutes of continuous stimulation, and a 30-second ramp-down.
干预措施: Speech therapy sessions (Behavioral)
Behavioral speech therapy combined with sham tDCS
Each participant will complete ten treatment sessions over approximately ten weeks. In each session, participants will receive sham tDCS for 30 minutes while concurrently engaging in behavioral speech therapy. Sham stimulation will involve the same ramp-up and ramp-down but with no current delivered during the 30-minute period to maintain blinding.
干预措施: Soterix Medical 1x1 tDCS system (Device)
Behavioral speech therapy combined with sham tDCS
Each participant will complete ten treatment sessions over approximately ten weeks. In each session, participants will receive sham tDCS for 30 minutes while concurrently engaging in behavioral speech therapy. Sham stimulation will involve the same ramp-up and ramp-down but with no current delivered during the 30-minute period to maintain blinding.
干预措施: Speech therapy sessions (Behavioral)
Behavioral speech therapy combined with active tDCS
Each participant will complete ten treatment sessions over approximately ten weeks. In each session, participants will receive active tDCS for 30 minutes while concurrently engaging in behavioral speech therapy. Active stimulation will include a 30-second ramp-up to 2.0 mA, 30 minutes of continuous stimulation, and a 30-second ramp-down.
干预措施: Soterix Medical 1x1 tDCS system (Device)
结局指标
主要结局
Change in Stuttering Severity Instrument - 4th Edition (SSI-4) total score
时间窗: Baseline, Visit 15 (~1-2 weeks post-intervention)
The Stuttering Severity Instrument-4th Edition (SSI-4) provides a total score that is compared to age-specific norms to determine severity, with ranges for "Very Mild" to "Very Severe". The SSI-4 calculates individual scores for frequency (2-18), duration (2-18), and physical concomitants (0-20). These individual scores are combined to create a total score, which is then ranked against norms to provide a verbal severity descriptor, such as mild, moderate, severe, or very severe.
Change in the Wright and Ayre Stuttering Self-Rating Profile (WASSP) score
时间窗: Baseline, Visit 15 (~1-2 weeks post-intervention)
The WASSP produces a profile of scores across five subscales. There is a total of 26 items each scored on a seven-point Likert-type scale. A score of '1' represents the least severe/negative perception, while a '7' represents the most severe/negative perception on each scale. Total scores range from 26-182, with higher scores indicating a greater negative impact of stuttering on their life.
Stuttering impact as assessed by the Overall Assessment of the Speaker's Experience of Stuttering - Adults (OASES-A)
时间窗: Baseline, Visit 15 (~1-2 weeks post-intervention)
The OASES-A is a tool used by speech-language pathologists to measure the adverse impact of stuttering on an adult's life. It consists of 100 questions rated on a 5-point scale (1-5). The scores from individual questions are added together to create an overall score. The total score is then used to determine the "Impact Rating" on a scale from mild to severe. Higher scores indicate higher levels of negative impact.
Change in the Brief Version of the Unhelpful Thoughts and Beliefs About Stuttering Scales (UTBAS-6) total score
时间窗: Baseline, Visit 15 (~1-2 weeks post-intervention)
The UTBAS-6 is a six-item screening questionnaire for adults who stutter to measure unhelpful thoughts and beliefs associated with speech anxiety. The UTBAS-6 has a subscale score range of 6 to 30 and a total score range of 18 to 90. A higher score indicates more frequent unhelpful thoughts and greater anxiety related to stuttering.
Change in Brief Fear of Negative Evaluation (BFNE-S) Scale total score
时间窗: Baseline, Visit 15 (~1-2 weeks post-intervention)
The BFNE-S consists of 8 items that are rated on a five-point likert scale from 1 (not at all characteristic) to 4 (extremely characteristic). Scores range from 0 to 32. A score of 25 or higher may indicate clinically significant social anxiety.
Social Interaction Anxiety Scale (SIAS)
时间窗: Baseline, Visit 15 (~1-2 weeks post-intervention)
The SIAS is a 20-item self-report questionnaire that measures the severity of social anxiety. Each item is rated from 0 (not at all characteristic or true of me) to 4 (extremely characteristic or ture of me). Scores can range from 0 (no social anxiety) to 80 (maximum social anxiety). A score of 36 or higher is often considered clinically significant, suggesting the presence of social anxiety.
次要结局
- Change in regional activation in/between cognitive control and speech motor areas during a delayed-naming task(Baseline, Visit 15 (~1-2 weeks post-intervention))
- Change in functional connectivity in/between cognitive control and speech motor areas during a delayed-naming task(Baseline, Visit 15 (~1-2 weeks post-intervention))