Examining Speech Production Errors in Stuttering Through High Definition - Transcranial Direct Current Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Stuttering Severity Instrument - 4
研究概览
简要总结
The goal of this study is to find out whether a type of noninvasive brain stimulation can help reduce speech errors, such as repetitions, blocks, and prolongations, in people who stutter. This pilot study will help researchers design future treatments to see if targeting certain brain areas can improve speech fluency. The study will look at how people speak and behave during both speaking and non-speaking tasks before and after the brain stimulation.
Participants will complete an online survey about 24 hours before coming to the clinic. The clinic visit will last about 3 hours and will include three phases. All parts of the study will be audio-recorded.
- Pre-Testing: Participants will first complete a stuttering evaluation to determine whether they are typical speakers or have a mild, moderate, or severe stutter. Then, they will do several speaking and non-speaking tasks.
- Brain Stimulation: Participants will receive a session of targeted noninvasive brain stimulation (HD-tDCS).
- Post-Testing: After the brain stimulation, participants will repeat the same evaluation and tasks they completed during pre-testing.
Brain stimulation description:
HD-tDCS is a non-invasive technique that requires the placement of several sensors (metal electrodes) on a special cap and saline gel on your head. Very low levels of constant electrical current are delivered to specifically targeted areas of the brain via these electrodes. You may experience a slight feeling of dizziness when starting the stimulation. This occurs in a small number of subjects. This takes only a few seconds and does not affect balance after the stimulation has been completed. Several research centers have previously investigated the use of this device on healthy subjects and have found the device to be safe with no direct effect on the person's well-being. Following stimulation, participants will have the opportunity to rinse out residual gel from hair and scalp.
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
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 22 years old or older
- •May be bi/multilingual but must speak English as dominant language.
- •Must be diagnosed or suspected of developmental stuttering disorder. Participants will be administered the Stuttering Severity Instrument 4 and categorized as typical speakers or mild, moderate, or severe stutterers.
- •Must be able to attend the session at the physical location within the clinic
排除标准
- •Patients with preexisting speech/language disorders or previously diagnosed neurological disorders (including but not limited to apraxia of speech, cerebral palsy, dysarthria, tourettes, or any other neurological/motor condition) that affect speech/language (except stuttering) are excluded to minimize the interference of atypical brain activity.
- •Participants who have acquired or neurogenic stuttering (stuttering resulting from a brain injury) are excluded, as this study focuses exclusively on the effects of developmental stuttering.
- •Participants with a history of seizures
- •Participants with unexplained episodes of loss of consciousness, since such condition could be related with brain alterations or epilepsy
- •Participants with unstable or non controlled neuropsychiatric illness
- •Participants having implanted brain medical devices
- •Participants with implanted pacemakers
- •Participants having any electrically,magnetically or mechanically activated implant
- •Participants having cardiac, neural or medication implants
- •Participants having vascular clips or any other electrically sensitive support system in the brain
- •Participants with serious brain injury
- •Participants showing damage of skin at sites of stimulation (the device can only be used in healthy skin without wounds, otherwise the resistance to current can be altered)
- •Participants suffering from skin problems, such as dermatitis, psoriasis or eczema
- •Participants suffering from severe or frequent headaches
- •Participants with any serious life-threatening disease such as congestive heart failure, pulmonary obstructive chronic disease, or active neoplasia
- •Pregnant women
- •Participants may not consume alcohol or controlled substances within 24 hours of the scheduled appointment
- •Participants will complete an additional screener upon enrollment to assess medical history and current drug/medication use that may conflict with the study.
研究组 & 干预措施
Left Inferior Frontal Gyrus
This arm is designed to analyze if treatment on the speech production area of the brain (also known as Broca's area) will decrease speech errors and increase ease of production in people who stutter
干预措施: High - Definition Transcranial Direct Current Stimulation (Device)
Presupplementary motor area
This arm is designed to investigate whether treatment targeting the motor planning region of the brain can reduce speech errors and increase ease of production in individuals who stutter.
干预措施: High - Definition Transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Stuttering Severity Instrument - 4
时间窗: Measured at singular clinical visit (baseline)
Stuttering Severity Instrument-Fourth Edition (SSI-4) is a reliable and valid norm-referenced stuttering assessment that can be used for both clinical and research purposes. It measures stuttering severity in both children and adults in the four areas of speech behavior: frequency duration physical concomitants naturalness of the individual's speech. The SSI-4 scores stuttering severity by combining measures of frequency (% syllables stuttered), duration (length of longest stutters), and physical concomitants (secondary behaviors) into a total score, which is then converted to a percentile rank and severity level (very mild to very severe) using age-specific standards. Higher percentile scores indicate more severe stuttering, with ranges like 1-4% being very mild and 96-99% very severe.
Predictive Naming Task
时间窗: Measured at singular clinical visit (baseline)
Participants are instructed to name images on a screen, given phrases that indicate high or low predictability for the target word. Task is measured by accuracy (number of correct answers) and participant response time.
次要结局
- Overall Assessment of the Speaker's Experience of Stuttering(Completed during enrollment process (24 hours pre-visit during consent))
- Button push Go/NoGo task(Measured at singular clinical visit (baseline))
研究者
John Hart, Jr.
Principal Investigator
The University of Texas at Dallas