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临床试验/NCT06376500
NCT06376500招募中不适用

Effects of Transcranial Direct Current Stimulation for Enhancing Cognitive Function in Individuals With Persistent Post-Concussion Syndrome: A Pilot fMRI/1H-MRS Study

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月1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
40
试验地点
1
主要终点
Average standardised score of executive function tests

研究概览

简要总结

Globally, 10 million new traumatic brain injury (TBI) cases are estimated annually, with mild traumatic brain injury (mTBI) accounting for 75-90% of all TBI cases. It is estimated that 40-80% of individuals with mTBI may experience the post-concussion syndrome (PCS), which is characterized by a range of physical, cognitive, and emotional symptoms. Although the underlying basis of cognitive dysfunction of patients with persistent PCS remains to be clarified, converging evidence shows that the clinical symptoms is underpinned by abnormal neural information processing as a result of axonal injury due to mTBI. Recent studies have demonstrated abnormalities in both structural and functional cortical connectivity, and a loss of cortical excitability-inhibitory (E/I) balance after TBI. Yet, there is no consensus for treating chronic symptoms of concussion, and PCS remains a chronic and highly disabling condition. One potential treatment option is transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique that has been shown to modify behavior by enhancing connectivity between targeted brain areas. However, research on the therapeutic effect of tDCS on PCS symptoms is limited, and the neurologic mechanisms underlying its effects are not well understood. The proposed study aims to address these knowledge gaps by examining the effects of tDCS on the central nervous system function in patients with PCS, with a specific focus on functional cortical connectivity and cognitive functions such as processing speed and executive function. The study also aims to add value to existing evidence by potentially opening new directions for designing intervention programs for the treatment of PCS after mTBI.

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
Triple (Participant, Care Provider, Outcomes Assessor)

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

  • being 18 years old or older;
  • having a history of a mild TBI (less than 30 minutes loss of consciousness) 1-6 years prior to the study;
  • able to communicate in Chinese.

排除标准

  • being without a confirmed diagnosis from the medical practitioner;
  • having a history of other neurological and psychiatric disorders, skull defect, recent medical instability (within 3 weeks);
  • being pregnant;
  • being medication for a psychiatric condition (e.g., major depression, anxiety, schizophrenia);
  • with any implanted devices or suffering from real claustrophobia or feel uncomfortable in small, enclosed spaces, like MRI tunnel

结局指标

主要结局

Average standardised score of executive function tests

时间窗: First day of intervention, 1 day after the last day of intervention (2 time points, up to 2 weeks)

The executive function of the PCS subjects will be assessed using the Executive Composite score, which combines scores from various executive function tests.Simple-task processing speed will be evaluated using the CANTAB® 5-choice Reaction Time (RTI) task, which measures the ability to focus on relevant information while ignoring distractions. It requires participants to react as soon as a yellow dot appears on screen. Complex-task processing speed will be assessed using the computerized version of the Wisconsin Card Sorting Test (WCST), which assesses cognitive flexibility. The test requires subjects to correctly match the response cards with several stimulus cards according to feedback provided based on a rule. The mean reaction time is calculated for the trials giving a correct answer during WCST. The reaction time measured from both tasks will be converted to standard scores and averaged to yield an executive composite score. Lower scores indicate poorer executive functioning.

次要结局

  • Change in CANTAB® cognitive test - Reaction Time (RTI)(First day of intervention,1 day after the last day of intervention (2 time points, up to 2 weeks))
  • Change in CANTAB® cognitive test - Multitasking Test (MTT)(First day of intervention,1 day after the last day of intervention (2 time points, up to 2 weeks))
  • Change in CANTAB® cognitive test - Spatial Working Memory (SWM)(First day of intervention,1 day after the last day of intervention (2 time points, up to 2 weeks))

研究者

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

Dr Yvonne Han

Associate Professor

The Hong Kong Polytechnic University

研究点 (1)

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