跳至主要内容
临床试验/NCT06830174
NCT06830174招募中不适用

Network Targeted Transcranial Direct Current Stimulation (tDCS) as a Treatment for Laryngeal Dystonia (LD)

Yale University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年4月14日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
Change in Cepstral peak prominence (CPP)

研究概览

简要总结

This project will apply transcranial direct current stimulation (tDCS) to multiple brain areas to evaluate the effects as a potential treatment for laryngeal dystonia (formerly spasmodic dysphonia).

详细描述

Baseline neuroimaging data will be acquired from all participants via MRI, EEG. Each participant will be seen for multiple testing sessions over a five day period. LD participants will undergo the neuromodulation (HD-tDCS Stimulation) for twenty minutes while engaged in watching videos/movies or performing a word production task.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

Subjects and staff will be blind during the study and that subjects will be told of their assignment at the follow-up visit.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must be clinically evaluated for the diagnosis of LD or have the proof of LD diagnosis. (Not applicable for control participants)
  • No other known or history of speech, voice disorder other than LD.
  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Must not be pregnant.

排除标准

  • All individuals who do not meet the above mentioned criteria are excluded from the study.
  • Subjects with a history of epilepsy or depression or is claustrophobic.

研究组 & 干预措施

Laryngeal Dystonia (LD) tDCS

Experimental

Adductor, Abductor and Mixed type LD with clinical evaluation of LD or with proof of LD diagnosis

干预措施: Starstim system (Device)

结局指标

主要结局

Change in Cepstral peak prominence (CPP)

时间窗: daily on Day 1-Day 5

Cepstral peak prominence (CPP) as a robust objective measure of voice quality in the active, sham and no stimulation conditions.

Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)

时间窗: daily on Day 1-Day 5

Its primary purpose is to describe the severity of auditory-perceptual attributes of a voice problem, in a way that can be communicated among clinicians

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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