Dopamine and Sensorimotor Function in Stuttering
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Pre-speech auditory modulation
研究概览
简要总结
This study is being done to understand the effect of aripiprazole on adults who stutter. Stuttering is a disorder that affects speech fluency. This study aims to understand sensorimotor pathways of stuttering and possible interventions.
详细描述
Stuttering is a disorder of speech fluency that affects 3.5 million people in the USA alone. The goal of this project is to assess whether fluency ehnancement with auditory feedback manipulations or with pharmacological agents that regulate dopamine uptake improve the sensorimotor functions of speech feedback prediction and processing in stuttering.
This study may lay the foundation for stuttering treatments that combine dopamine regulators and behavioral treatments. Aripiprazole is an FDA-approved anti-psychotic typically used for treatment of schizophrenia or acute manic episodes. A typical dose is 10-15 mg per day, given daily for treatment. In this study, one 10 mg dose will be given. The usage in this study is purely investigational (experimental) and not FDA approved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, 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
- 是
入选标准
- •native speakers of American English
- •for adults who stutter, presence of stuttering will be confirmed, with onset before age 6 years
- •Normal hearing
- •Ages of 18 to 65 years
- •healthy adults without hearing-language difficulties
排除标准
- •self-reported speech-language-hearing difficulties other than stuttering
- •self-reported neurological or psychological problems
- •other medications (drugs that affect dopaminergic system and/or benzodiazepines)
研究组 & 干预措施
Single dose of aripiprazole
Single dose of aripiprazole, 10mg administered orally. Participant and administrator will be blinded.
干预措施: Aripiprazole 10 MG (Drug)
Placebo dose
A single placebo dose will be administered.
干预措施: Placebo (Drug)
结局指标
主要结局
Pre-speech auditory modulation
时间窗: 3-4 hours after intervention dose is delivered
Pre-speech auditory modulation (PSAM) is a measure of auditory cortical activity (as collect via magnetoencephalography) in response to a speaking and and matching silent reading task.
Speaking Induced Suppression (SIS)
时间窗: 3-4 hours after intervention
SIS is a phenomenon measured through magnetoencephalography that is a marker of auditory cortical response to self-produced speech compared with playback of the same speech.
Centering
时间窗: 3-4 hours after intervention
This is a speech behavior associated with SIS involving a reduction of speech variability from speech onset to mid-utterances. This is derived from auditory recordings occurring during magnetoencephalography collection.
Feedback alterations
时间窗: 3-4 hours after intervention
This is a measure of fluency enhancement by altered speech feedback (manipulated by methods such as masking noise, frequency shifted feedback,. etc.) This is measured through audio recordings and brain activation patterns during magnetoencephalography.
次要结局
未报告次要终点