Transcranial Magnetic Stimulation in Laryngeal Dystonia
2026年6月27日 更新者：Kátia Monte-Silva、Universidade Federal de Pernambuco
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.
研究概览
研究类型
介入性
注册 (估计的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Katia K Monte-Silva
- 电话号码：+55(81) 99503-2493
- 邮箱：monte.silva@ufpe.br
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Active rTMS
Participants will receive active repetitive transcranial magnetic stimulation (rTMS) alone, delivered according to the study protocol, without concurrent speech-language therapy.
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Active repetitive transcranial magnetic stimulation (rTMS) delivered using a magnetic stimulator according to the study protocol.
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实验性的：Active rTMS + Speech-Language Therapy
Participants will receive active repetitive transcranial magnetic stimulation (rTMS) combined with speech-language therapy, administered according to the standardized intervention protocol.
|
Active repetitive transcranial magnetic stimulation (rTMS) delivered using a magnetic stimulator according to the study protocol.
Standardized speech-language therapy focused on voice rehabilitation delivered by a licensed speech-language pathologist according to the study protocol.
|
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假比较器：Sham rTMS + Speech-Language Therapy
Participants will receive sham repetitive transcranial magnetic stimulation (rTMS) combined with speech-language therapy.
Sham stimulation will mimic active rTMS without delivering therapeutic magnetic stimulation.
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Standardized speech-language therapy focused on voice rehabilitation delivered by a licensed speech-language pathologist according to the study protocol.
Sham repetitive transcranial magnetic stimulation (rTMS) delivered using a sham stimulation procedure designed to mimic active rTMS without delivering therapeutic magnetic stimulation.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Acoustic Voice Parameters Assessed Using VoxMetria® and FonoView® Software
大体时间：through study completion, an average of 6 months
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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.
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through study completion, an average of 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Vocal Effort Assessed by the Borg Category Ratio 10 Scale for Vocal Effort
大体时间：through study completion, an average of 6 months
|
Vocal effort will be assessed using the Borg Category Ratio 10 Scale for Vocal Effort.
Scores range from 0 to 10, where 0 indicates no vocal effort and 10 indicates maximum vocal effort.
Higher scores indicate worse perceived vocal effort.
|
through study completion, an average of 6 months
|
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Patient Global Impression of Change Assessed by the Patient Global Impression of Change Scale
大体时间：through study completion, an average of 6 months
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Global perceived change will be assessed using the Patient Global Impression of Change Scale.
Scores range from 1 to 7, where 1 = very much worse and 7 = very much improved.
Higher scores indicate greater perceived improvement.
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through study completion, an average of 6 months
|
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Voice-Related Quality of Life Assessed by the Voice-Related Quality of Life Questionnaire (Brazilian Portuguese Version - QVV)
大体时间：through study completion, an average of 6 months
|
Voice-related quality of life will be assessed using the Voice-Related Quality of Life (V-RQOL) questionnaire, validated for Brazilian Portuguese (QVV).
Scores range from 0 to 100, with higher scores indicating better voice-related quality of life.
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through study completion, an average of 6 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Perceptual-auditory voice assessment
大体时间：through study completion, an average of 6 months
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Perceptual-auditory evaluation of voice quality performed by trained raters, based on standardized speech and sustained vowel tasks.
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through study completion, an average of 6 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Nathália Suellen Valeriano Cardoso Cardoso、UFPE - nathalia.suellen@ufpe.br
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2026年8月1日
研究完成 (估计的)
2027年2月1日
研究注册日期
首次提交
2026年1月20日
首先提交符合 QC 标准的
2026年6月27日
首次发布 (实际的)
2026年7月6日
研究记录更新
最后更新发布 (实际的)
2026年7月6日
上次提交的符合 QC 标准的更新
2026年6月27日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.