NCT07577310尚未招募不适用
False Vocal Fold vs EMG-Guided Botulinum Toxin Injections for Voice Tremor (FVFIVT): Prospective Non-Randomized Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This is a prospective, non-randomized, two-arm comparative clinical trial evaluating outcomes of false vocal fold (FVF) botulinum toxin injections versus standard EMG-guided botulinum toxin injections in patients with essential voice tremor. Participants will receive either FVF injections or EMG-guided injections based on shared clinical decision-making between the treating laryngologist and patient. The study will assess changes in voice-related quality of life, tremor severity, and patient satisfaction over a 12-week follow-up period and compare these outcomes between the two treatment approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Age ≥18 years
- •Diagnosis of essential voice tremor by a laryngologist and speech pathologist
- •Deemed an appropriate candidate for either FVF or EMG-guided botulinum toxin injections
- •Able to provide informed consent and complete questionnaires in English
排除标准
- •Coexisting severe neurologic disease that precludes reliable participation in follow-up
- •History of laryngeal surgery or structural lesion that markedly confounds tremor assessment
- •Known hypersensitivity to botulinum toxin or injectable components
- •Pregnancy
- •Dysphagia at baseline
- •Inability to comply with follow-up schedule
研究者
Blake Simpson
Professor
University of Alabama at Birmingham
研究点 (1)
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