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Effects of tDCS for Enhancing Cognitive Function in Individuals With Persistent Post-Concussion Syndrome

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 3 of 3 entries
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2025 to Sep 1, 2025
    • Site details revised
    v5
  3. Notable Start date: Feb 2025 to Apr 2025v4
  4. Notable Start date: Dec 2024 to Feb 2025v3
  5. Notable Start date: Jun 2024 to Dec 2024
    • Primary endpoint revised
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06376500
Lead Sponsor The Hong Kong Polytechnic University
Conditions
(from sponsor)
Transcranial Direct Current Stimulation, Post-Concussion Syndrome, Functional Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy
Related terms Post-Concussion Syndrome
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov