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临床试验/NCT05834920
NCT05834920招募中不适用

Effects of Neurofeedback and Transcranial Pulse Stimulation on Attention

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2023年3月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
1
主要终点
Change from baseline in gradCPT continuous performance test

研究概览

简要总结

The present study aims to examine and compare the effectiveness of transcranial pulse stimulation and neurofeedback among adults who are weak in attention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Aged 20 years and above
  • Right-handed
  • Normal/corrected hearing and vision
  • Having basic literacy skills
  • Having sustained attention scores below the threshold

排除标准

  • Having medical history related to brain
  • Having mild cognitive impairment
  • Showing symptoms of depression and anxiety
  • Having intellectual disability based on IQ scores
  • Having diagnoses of any psychiatric or cognitive disorders besides attention deficit hyperactivity disorder (ADHD) inattentive and combined types
  • Having long-term history of smoking cigarettes
  • Engaged in alcohol and/or substance abuse
  • Having history of hemophilia or other blood clotting disorders or thrombosis
  • Having corticosteroid treatment within the last six weeks before first intervention
  • Having contraindications for MRI scanning

结局指标

主要结局

Change from baseline in gradCPT continuous performance test

时间窗: Baseline, week 4, week 8, week 12, week 16

The GradCPT is a continuous performance test to measure sustained attention. It has been shown to reliably indicate attentional fluctuation over time. Participants are required to respond to frequently presented city scene and inhibit responses to infrequently presented mountain scene. The sequence of visual stimuli is presented with gradual transitions to minimize involuntary attention capture by abrupt stimulus onset and offset. The main outcome of interest is reaction times variability, with higher variability indicating poorer sustained attention.

Change from baseline in Conners' Continuous Performance Test 3rd Edition

时间窗: Baseline, week 4, week 8, week 12, week 16

The Conners' Continuous Performance Test (CPT) measures inattentiveness, impulsivity, sustained attention, and vigilance. Participants are required to push the spacebar when any letter, except "X", appears. Performances are measured in raw scores and standardized T scores. T scores between 45-54 indicate average performance, higher or lower scores indicate atypical performance.

次要结局

  • Change from baseline in Stroop task(Baseline, week 4, week 8, week 12, week 16)
  • Change from baseline in Color Trails Test(Baseline, week 4, week 8, week 12, week 16)
  • Change from baseline in Hospital Anxiety and Depression Scale (HADS)(Baseline, week 4, week 8, week 12, week 16)
  • Change from baseline in Rosenberg Self-esteem Scale(Baseline, week 4, week 8, week 12, week 16)
  • Change from baseline in General Health Questionnaire(Baseline, week 4, week 8, week 12, week 16)
  • Change from baseline in Goal Orientation Scale(Baseline, week 4, week 8, week 12, week 16)
  • Change from baseline in Attentional Control Scale(Baseline, week 4, week 8, week 12, week 16)
  • Change from baseline in N-back task(Baseline, week 4, week 8, week 12, week 16)
  • Change from baseline in Social Connectedness Scale(Baseline, week 4, week 8, week 12, week 16)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Teresa Wijaya

Post-doctoral Fellow

The University of Hong Kong

研究点 (1)

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