Repetitive Transcranial Magnetic Stimulation in Spasmodic Dysphonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Duration of Cortical Silent Period (CSP)
研究概览
简要总结
Focal dystonia is a neurological movement disorder characterized by excessive involuntary muscle contractions of any body part. Spasmodic dysphonia (SD) is a type of focal dystonia characterized by excessive contraction of intrinsic muscles in the larynx, leading to difficulty in speaking and affecting effective communication. The cause of SD is unknown and there are no treatments that produce long-term benefits. Previous studies have suggested that SD and other focal dystonias are associated with decreased inhibition in sensorimotor areas in the brain. However, no studies have investigated the effects of modulating excitability of the laryngeal motor cortex in healthy individuals or SD. The goal of this pilot project is to determine if brain excitability of the laryngeal motor cortex can be changed with low-frequency inhibitory repetitive transcranial magnetic stimulation (rTMS) in individuals with SD and healthy controls. Considering that rTMS at low frequencies (≤1 Hz) produces lasting inhibition in the brain, and that SD is associated with decreased cortical inhibition, the purpose of this pilot study is to determine safety, feasibility and response to 1Hz rTMS to the laryngeal motor cortex in individuals with SD and healthy people. The results will help understand changes associated with the disorder, as well as contribute to the development of future clinical interventions for SD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary inclusion for spasmodic dysphonia:
- •Diagnosis of adductor spasmodic dysphonia
- •Symptoms at worst severity if receiving regular botulinum injections
- •Primary inclusion for healthy participants (controls):
- •Absence of vocal fold pathology
排除标准
- •Primary exclusion for participants with spasmodic dysphonia:
- •Other forms of dystonia
- •Vocal fold pathology or paralysis
- •Diagnosis of voice tremor
- •Laryngeal surgery
- •Laryngeal cancer or neurological condition other than dystonia
- •Contraindication to TMS
- •Medications with effect on central nervous system
- •Inability to complete tasks associated with study
- •Adult lacking ability to consent
- •Primary exclusion for healthy participants (controls):
- •Any health condition or disability that would interfere with participation
- •Contraindications to TMS
- •Medications with effect on central nervous system
- •Adult lacking ability to consent
- •TMS contraindications:
- •The only absolute contraindication to TMS/rTMS is the presence of metallic hardware in close contact to the discharging coil (such as cochlear implants, deep brain stimulator, or medication pumps). In such instances there is a risk of inducing malfunctioning of the implanted devices.
- •Conditions classified as of increased or uncertain risk are listed below (Rossi et al., 2009; Rossini et al., 2015). Persons under those circumstances will be excluded from the study.
- •Bipolar disorder
- •Epilepsy or history of seizure episodes in the past two years
- •Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without history of seizure, and without anticonvulsant medication
- •Use of medications that potentially lower seizure threshold
- •Severe or recent heart disease
结局指标
主要结局
Change in Duration of Cortical Silent Period (CSP)
时间窗: baseline and 2.5 hours
The change from baseline in CSP duration will be reported. The CSP is an interruption of voluntary muscle contraction after single pulse transcranial stimulation. The duration of the period of silent muscle activity will be measured to test the effects of rTMS intervention. There is no known clinical relevance for this outcome measure.
Adverse Response to rTMS
时间窗: 2.5 hours
Count of participants who experience and adverse response to rTMS treatment.
次要结局
- Change in Cepstral Peak Prominence Smoothed (CPPS)(baseline and 2.5 hours)
- Change in Number of Voice Breaks(baseline and 2.5 hours)
- Change in Voice Quality (Overall Severity) With the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)(baseline and 2.5 hours)