跳至主要内容
临床试验/NCT05472181
NCT05472181招募中不适用

The Effects of Brain Stimulation on Enhancement of Speech Fluency in Adults Who Stutter

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2022年10月1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
18
试验地点
1
主要终点
Stuttering severity

研究概览

简要总结

The project is leading to investigate the effects of neuromodulation techniques on speech fluency among adults who stutter (AWS). While stuttering is responsive to a variety of treatments in childhood, this is not the case for AWS. Behavioural treatments to reduce stuttering for adults typically consist of speech restructuring methods, which involves the person using one of the altered speech patterns known to increase fluency, such as chorus reading, speaking in rhythm, and prolonging (smoothing/stretching out) speech sounds. Research has shown that behavioural interventions such as these change brain activation patterns in the regions associated with stuttering. Unfortunately, around 70% of AWS who receive these speech restructuring treatments do not maintain the benefits in the longer term and frequently re-present to speech clinics. The aim of this proposed research is to explore whether the brain stimulation using repetitive transcranial magnetic stimulation (rTMS) can consistently enhance effects of behavioural stuttering therapy by examining their responsiveness to the treatment across different outcome measures including a) immediate effect on different speaking contexts, and b) the maintenance of effects over one week after therapy.

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)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •adults who stutter without any other speech, language or cognitive problems

排除标准

  • •have any history of neurological and other speech and language problems
  • •condition that are violating the safety criteria for TMS
  • •any history of epilepsy, and brain damage,
  • •having any metal plant or cardiac pace-maker in the body,
  • •current pregnancy

研究组 & 干预措施

rTMS (Repetitive TMS)

Active Comparator

The rTMS group will receive 30 minutes of excitatory rTMS (i.e., 60 trains of 10 Hz pulses for 5 second with over 120% of motor threshold) over SMA combined with speech training (for 25 seconds during the 60 inter-train intervals) for five sessions

干预措施: rTMS (Repetitive TMS) (Device)

rTMS (Repetitive TMS)

Active Comparator

The rTMS group will receive 30 minutes of excitatory rTMS (i.e., 60 trains of 10 Hz pulses for 5 second with over 120% of motor threshold) over SMA combined with speech training (for 25 seconds during the 60 inter-train intervals) for five sessions

干预措施: Speech training (Behavioral)

Sham

Sham Comparator

The sham group will receive 30 minutes of sham rTMS (no magnetic stimulation) over SMA combined with speech training (for 25 seconds during the 60 inter-train intervals) for five sessions.

干预措施: Speech training (Behavioral)

结局指标

主要结局

Stuttering severity

时间窗: Immediately and one week after the treatment block

The stuttering severity will be measured by Stuttering severity instrument-4 (SSI-4)

次要结局

  • Treatment satisfaction(one week after the treatment block)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验