Non-invasive Brain Stimulation in Adults Who Stutter
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in Percentage of Stuttered Syllables Produced During Speech Sample
研究概览
简要总结
Research studies in stuttering have shown that activity patterns in certain brain areas differ in people who stutter compared to people who do not stutter when speaking. The purpose of this study is to investigate how mild, non-invasive brain stimulation applied consecutively for five days affects speech relevant brain areas, which may in turn affect speech fluency and speaking-related brain activity in people who stutter.
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 who is not involved in any aspect of the study will randomize participants into the sham and active study arms using a minimization procedure. Allocation concealment will be achieved by assigning a unique 6-digit random code per participant, which will be provided to the researcher. The code is used to deliver stimulation. The participants and the researchers who deliver stimulation, assess outcomes, and analyze data will be masked to trial arm.
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
- •history of persistent developmental stuttering
- •stuttering severity ranging from mild to very severe, specifically Stuttering Severity Instrument (SSI) total score of 20 (mild) or higher and stuttering rates of 3% or higher
- •scores within 1 standard deviation of the norm on the standardized tests for the study
排除标准
- •received any treatment for stuttering within the past year
- •other neurological conditions such as Tourette's syndrome or post-traumatic stress disorder
- •taking any medications/drugs that affect brain function
- •history of past or current mental illness for example, schizophrenia that may affect brain development and function
- •history of serious medical or neurological illness such as epilepsy and Parkinson's disease
- •history of closed head injury (e.g., concussion)
- •history of reading disorders
- •hearing loss
- •taking any medication, prescription or non-prescription with any psychotropic effects at the time of the study
- •metal or electronic implants such as cochlear implants, and pacemakers
结局指标
主要结局
Change in Percentage of Stuttered Syllables Produced During Speech Sample
时间窗: Baseline, 1 week (post), 4 weeks (follow up)
Investigators will calculate the percentage of stuttered syllables (out of total syllables) in a speech sample. Decreased stuttered syllables represents better outcomes (greater reduction in stuttering).
Changes in Brain Activation as Assessed by fMRI Images
时间窗: Baseline, 1 week (post), 4 weeks (follow up)
Investigators will use the fMRI images taken from before and after tDCS to determine if the treatment intervention contributed to any changes within brain regions associated with speech production. This will be measured by Blood-Oxygen-Level-Dependent (BOLD) signal change (arbitrary units). Images from scans are preprocessed. Changes in BOLD signal are modeled for contrasts within a group for \[post-pre\] and \[follow up-pre\] (e.g., active group reading condition post visit MINUS active group reading pre visit). Results are reported for reading condition.
次要结局
- Changes From Baseline on the Overall Assessment of Speakers Experience of Stuttering (OASES)(Baseline, 1 week (post), 4 weeks (follow up))
研究者
Emily O'Dell Garnett
Research Investigator
University of Michigan