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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство tDCS with cognitive training programme
  Participants will complete tDCS over 10 sessions in 2 weeks (once per day, for 10 consecutive working days), while performing the executive function training tasks. The training session will last for 20 minutes and it is comprised of 5 exercises targeting at information processing speed and executive function capacities. Each exercise lasts for approximately 4 minutes, totaling approximately 20 minutes.

Первичные конечные точки

• Average standardised score of executive function tests [Срок оценки: First day of intervention, 1 day after the last day of intervention (2 time points, up to 2 weeks)]

Вторичные конечные точки (3)

• Change in CANTAB® cognitive test - Reaction Time (RTI) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: First day of intervention,1 day after the last day of intervention (2 time points, up to 2 weeks)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Hong Kong Polytechnic University — Hung Hom

Идентификаторы

NCT: NCT06376500 · HSEARS20240223001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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