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临床试验/NCT03452202
NCT03452202招募中不适用

Using tDCS in Speech-based Stroke Rehabilitation

NYU Langone Health4 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年1月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
4
主要终点
Change in accuracy in recordings from tasks from baseline to post treatment

研究概览

简要总结

The purpose of this study is to determine whether the effect of treatment for acquired speech impairment can be enhanced by combining effective behavioral treatment with non-invasive brain stimulation. Transcranial direct current stimulation (tDCS), which delivers low-intensity current to the scalp, and is a safe and well-tolerated approach that poses a non-significant risk to participants. tDCS provides low intensity neural stimulation which has been shown to facilitate motor learning in other domains of stroke rehabilitation such as arm motor learning but the potential to enhance speech motor learning has not been explored. This will be examined with a series of single-case experimental designs.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Right-handed
  • Monolingual (English)
  • Single left-hemisphere CVA
  • A minimum of six months post-stroke
  • Clinical diagnosis of apraxia of speech
  • Normal speech perception
  • Passing score on the hearing screening.

排除标准

  • Diagnosis of laryngeal voice disorder
  • Dysarthria
  • History of speech impairment prior to CVA
  • Presence of potential tDCS risk factors: damaged skin at site of stimulation;
  • Presence of electrically or magnetically activated implant (including pacemaker);
  • metal in any part of their body;
  • history of medication-resistant epilepsy in the family;
  • past history of seizures or unexplained spells of loss of consciousness.

研究组 & 干预措施

Active Stimulation

Experimental

crossover design such that each participant receives behavioral treatment twice - once with active stimulation and once with sham stimulation - in order to evaluate differences in improvement based on treatment condition.

干预措施: Sham (Device)

Active Stimulation

Experimental

crossover design such that each participant receives behavioral treatment twice - once with active stimulation and once with sham stimulation - in order to evaluate differences in improvement based on treatment condition.

干预措施: Soterix 1x1 line tDCS low-intensity stimulator (Device)

Sham Stimulation

Sham Comparator

crossover design such that each participant receives behavioral treatment twice - once with active stimulation and once with sham stimulation - in order to evaluate differences in improvement based on treatment condition.

干预措施: Soterix 1x1 line tDCS low-intensity stimulator (Device)

Sham Stimulation

Sham Comparator

crossover design such that each participant receives behavioral treatment twice - once with active stimulation and once with sham stimulation - in order to evaluate differences in improvement based on treatment condition.

干预措施: Sham (Device)

结局指标

主要结局

Change in accuracy in recordings from tasks from baseline to post treatment

时间窗: Baseline, 6 Months

Subjects will be given speech production tasks. Recordings of tasks will be scored for accuracy to measure speech motor learning

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 (4)

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Using tDCS in Speech-based Stroke Rehabilitation | 临床试验