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Clinical Trials/NCT06376500
NCT06376500
Recruiting
Not Applicable

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 site in 1 country40 target enrollmentSeptember 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transcranial Direct Current Stimulation
Sponsor
The Hong Kong Polytechnic University
Enrollment
40
Locations
1
Primary Endpoint
Average standardised score of executive function tests
Status
Recruiting
Last Updated
7 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2025
End Date
February 1, 2028
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Yvonne Han

Associate Professor

The Hong Kong Polytechnic University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Average standardised score of executive function tests

Time Frame: 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.

Secondary Outcomes

  • 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))

Study Sites (1)

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