Laryngeal Vibro-tactile Stimulation as a Non-invasive Symptomatic Treatment for Spasmodic Dysphonia
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in perceived speech effort (PSE)
研究概览
简要总结
The general aim of the research is to provide scientific evidence that vibro-tactile stimulation (VTS) represents a non-invasive form of neuromodulation that can induce measurable improvements in the speech of patients with laryngeal dystonia (LD) - also called spasmodic dysphonia (SD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Confirmed diagnosis of adductor or abductor LD for a minimum of 6 months.
排除标准
- •Regular intake of benzodiazepines
- •Cognitive impairment: score < 27 on the Mini-mental State Examination (MMSE).
- •Identify with a neurological or musculoskeletal impairment affecting speech motor function. These impairments may include a form of: Dyskinesia, Dystonia other than LD, Essential Tremor, Huntington's Disease, Multiple System Atrophy, Muscle Tension Dysphonia, Parkinsonism, Progressive Supranuclear Palsy, Spasticity, Intracranial Neoplasm (brain tumor), Spinal Neoplasm, Cerebrovascular Accident (Stroke), Mild Traumatic Brain Injury, Intracranial Hemorrhage, Multiple Sclerosis.
- •Non-English speaker. We will not enroll people who cannot speak English, because the voice assessment procedures (Test sentences, CAPE_V clinical rating) have only been validated for English speakers at this point.
- •Pregnant people. We will not enroll pregnant people as the device used in this study is investigational.
结局指标
主要结局
Change in perceived speech effort (PSE)
时间窗: 24 months
Speaker will assess effort themselves and assign an score (range: 0-10 with a score of '10' indicating most severe effort)
Change in speech quality vector (SQV) (%)
时间窗: 24 months
A derived measure designed to understand if a participant's voice symptom improvement occurs across objective (CPPS) and subjective measures of speech (PSE). It is based on the relative change between two time points
Change in smoothed cepstral peak prominence (CPPS)
时间窗: 24 months
CPPS provides a measure of the strength of the fundamental frequency within background aperiodicity (physical unit is dB)
次要结局
未报告次要终点