Transcranial Magnetic Stimulation in Laryngeal Dystonia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Acoustic Voice Parameters Assessed Using VoxMetria® and FonoView® Software
研究概览
简要总结
This randomized clinical trial with a crossover design aims to investigate the effects of neuromodulation through repetitive transcranial magnetic stimulation (rTMS) applied to patients diagnosed with laryngeal dystonia. Participants will undergo three experimental conditions: (1) rTMS alone, (2) rTMS combined with speech-language therapy, and (3) sham rTMS combined with speech-language therapy. The order of the conditions will be randomized. Each phase of the protocol will consist of five consecutive sessions.
Outcomes will include acoustic vocal quality parameters, perceptual-auditory voice assessment, self-ratings of vocal effort, smoothed cepstral peak prominence measures, and global perceived change following the intervention. It is expected that the study will contribute to a better understanding of the effects of the intervention on vocal outcomes, supporting the optimization and standardization of therapeutic protocols for laryngeal dystonia.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, care providers, and outcome assessors will be blinded to intervention condition (active vs sham).
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) of any sex with a confirmed diagnosis of laryngeal dystonia
- •Participants not undergoing botulinum toxin treatment at the time of the intervention
- •Ability to provide informed consent
- •Ability to complete all study assessments and intervention procedures
排除标准
- •Other forms of dystonia
- •Vocal fold lesions
- •Vocal fold paralysis
- •Contraindications to repetitive transcranial magnetic stimulation (rTMS)
- •Inability to complete study assessments or intervention procedures
结局指标
主要结局
Acoustic Voice Parameters Assessed Using VoxMetria® and FonoView® Software
时间窗: through study completion, an average of 6 months
Acoustic voice parameters will be assessed using VoxMetria and FonoView software during sustained vowel phonation and connected speech tasks. The analysis will include F0 standard deviation (F0 SD), F0 variability, semitone variability, jitter, cepstral peak prominence smoothed (CPPS), voiced time, and unvoiced time. Each parameter will be analyzed separately and reported as the change from baseline to post-intervention.
次要结局
- Vocal Effort Assessed by the Borg Category Ratio 10 Scale for Vocal Effort(through study completion, an average of 6 months)
- Patient Global Impression of Change Assessed by the Patient Global Impression of Change Scale(through study completion, an average of 6 months)
- Voice-Related Quality of Life Assessed by the Voice-Related Quality of Life Questionnaire (Brazilian Portuguese Version - QVV)(through study completion, an average of 6 months)
研究者
Kátia Monte-Silva
Professor
Universidade Federal de Pernambuco