振动触觉刺激治疗痉挛性发声困难的可用性
2026年6月24日 更新者:Juergen Konczak、University of Minnesota
喉部振动触觉刺激作为语音障碍痉挛性发声障碍的非侵入性治疗方法的可用性
该研究的总体目的是为在家中应用振动触觉刺激(VTS)作为一种非侵入性神经调节形式来改善痉挛性发声困难(SD)患者的言语能力的可用性和可行性提供证据。
这项工作满足了临床需求,为一种治疗选择非常有限的罕见嗓音疾病开发替代或辅助治疗方法。
成功完成拟议的工作将是推进喉部 VTS 作为改善 SD 声音症状的治疗干预措施的重要一步。
研究概览
详细说明
Participants with either adductor or abductor-type of spasmodic dysphonia applied VTS at home for a period of 2 months.
During the first four weeks they gradually increased their weekly dosage from 3 to 6 days per week.
Each application per day lasted 20 minutes.
研究类型
介入性
注册 (实际的)
40
阶段
- 阶段2
- 阶段1
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。
学习地点
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Minnesota
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Minneapolis、Minnesota、美国、55414
- University of Minnesota
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-
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
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准:
- 诊断为痉挛性发声障碍(喉肌张力障碍)至少 6 个月,并记录注射肉毒杆菌后症状缓解。
- 由嗓音障碍专家进行诊断。
排除标准:
- 定期摄入苯二氮卓类药物
- 认知障碍:简易精神状态检查得分<27
- 确定患有影响言语运动功能的神经或肌肉骨骼损伤。 这些障碍可能包括以下形式:运动障碍、肌张力障碍、特发性震颤、亨廷顿病、多系统萎缩、肌张力性发声障碍、帕金森病、进行性核上性麻痹、痉挛、颅内肿瘤(脑肿瘤)、脊柱肿瘤、脑血管意外(中风)、轻度脑外伤、颅内出血、多发性硬化症
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:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Intervention
Laryngeal vibro-tactile stimulation
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Participants received vibro-tactile stimulation (VTS) as a non-invasive treatment option.
Stimulators were a pair of light-weight encapsulated cylindrical vibrators applied to both sides of the larynx (voice box).
The vibration frequency for VTS was set be to 100Hz.
During VTS, participants feel a mild tingling or vibrating sensation at their larynx.
They applied VTS at home over a period of 8 weeks with a daily dosage of 20 minutes.
During weeks 1-4, the weekly dosage of VTS was gradually increased (week 1: 3 days/wk; week 2: 4 days/wk; week 3: 5 days/wk; week 4: 6 days/wk).
During weeks 5-8, participants applied VTS on self-selected days as needed, not exceeding 6 times a week.
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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 |
|---|---|---|
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Perceived Speech Effort (PSE) at Week 4
大体时间:Week 4
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Perceived Speech Effort was self-rated by participants on a 0-10 scale (0 = no effort, 10 = maximum effort) while reading standardized sentences at habitual pitch and loudness.
Ratings were collected immediately before and after each vibro-tactile stimulation session.
The PSE value reported here reflects the group mean at week 4.
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Week 4
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Perceived Speech Effort (PSE) at Week 8
大体时间:Week 8
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Perceived Speech Effort was self-rated by participants on a 0-10 scale (0 = no effort, 10 = maximum effort) while reading standardized sentences at habitual pitch and loudness.
Ratings were collected immediately before and after each vibro-tactile stimulation session.
The PSE value reported here reflects the group mean at week 8.
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Week 8
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Voice Quality Change (VQC) at Week 1
大体时间:Week 1
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Voice Quality Change (VQC) was self-assessed using a 5-point Likert scale (1 = very unnoticeable, 5 = very noticeable; 3 = neutral).
Ratings were recorded at the end of each VTS session.
VQC at week 1 represents a baseline measure of symptom severity.
It was computed as the mean of the first three sessions of VTS of the study.
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Week 1
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Voice Quality Change (VQC) at Week 8
大体时间:Week 8
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Voice Quality Change (VQC) was self-assessed using a 5-point Likert scale (1 = very unnoticeable, 5 = very noticeable; 3 = neutral).
Ratings were recorded at the end of each VTS session.
The score reflects the overall longitudinal change in symptoms experienced after treatment end.
VQC at week 8 was computed as the mean of the last three sessions of the study.
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Week 8
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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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Relative Change in Perceived Speech Effort (rPSE) for VTS Application Method
大体时间:8 weeks
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Relative change in PSE (rPSE) was calculated as [(Post - Pre) / Pre] × 100.
The between-group difference in mean rPSE comparing VTS received during direct skin contact vs. VTS collar was assessed over the total study period of 8 weeks to understand if the VTS applied directly to the skin was more effective in reducing speech effort than VTS applied via the collar.
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8 weeks
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Adherence Rate (Feasibility)
大体时间:Week 1-4
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Number of participants who completed at least 80% of prescribed VTS sessions during the intervention period.
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Week 1-4
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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:Juergen Konczak, PhD、University of Minnesota
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Konczak J, Bhaskaran D, Elangovan N, Oh J, Goding GS, Watson PJ. Effects of an 11-week vibro-tactile stimulation treatment on voice symptoms in laryngeal dystonia. Front Neurol. 2024 May 30;15:1403050. doi: 10.3389/fneur.2024.1403050. eCollection 2024.
- Mahnan A, Xu J, Oh J, Bhaskaran D, Zhang Y, Watson PJ, Konczak J. Laryngeal Vibration to Treat Abductor-Type Laryngeal Dystonia: Effectiveness and Cortical Response. Laryngoscope. 2026 Jan;136(1):368-376. doi: 10.1002/lary.70020. Epub 2025 Aug 8.
- Amini S, Elangovan N, Ozkul C, Konczak J. Usability and Feasibility of In-home Vibro-Tactile Stimulation for Treating Voice Symptoms in Laryngeal Dystonia. J Voice. 2025 Aug 23:S0892-1997(25)00329-7. doi: 10.1016/j.jvoice.2025.08.012. Online ahead of print.
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 (实际的)
2023年11月21日
初级完成 (实际的)
2024年10月28日
研究完成 (实际的)
2024年10月31日
研究注册日期
首次提交
2023年10月16日
首先提交符合 QC 标准的
2023年10月29日
首次发布 (实际的)
2023年11月1日
研究记录更新
最后更新发布 (实际的)
2026年7月15日
上次提交的符合 QC 标准的更新
2026年6月24日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- STUDY00019659
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.