Clinical trial NCT06376500: Effects of TDCS for Enhancing Cognitive Function in Individuals with Persistent Post-Concussion Syndrome
Official title: Effects of Transcranial Direct Current Stimulation for Enhancing Cognitive Function in Individuals with Persistent Post-Concussion Syndrome: a Pilot FMRI/1H-MRS Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Transcranial Direct Current Stimulation
Post-Concussion Syndrome
Functional Magnetic Resonance Imaging
Magnetic Resonance Spectroscopy
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Average standardised score of executive function tests
timeFrame: First day of intervention, 1 day after the last day of intervention (2 time points, up to 2 weeks)
Secondary outcomes:
measure: Change in CANTAB® cognitive test - Reaction Time (RTI)
timeFrame: First day of intervention,1 day after the last day of intervention (2 time points, up to 2 weeks)
measure: Change in CANTAB® cognitive test - Multitasking Test (MTT)
timeFrame: First day of intervention,1 day after the last day of intervention (2 time points, up to 2 weeks)
measure: Change in CANTAB® cognitive test - Spatial Working Memory (SWM)
timeFrame: First day of intervention,1 day after the last day of intervention (2 time points, up to 2 weeks)
Other outcomes:
measure: Exploratory mediator - default mode network (DMN) activation
timeFrame: First day of intervention,1 day after the last day of intervention (2 time points, up to 2 weeks)
measure: Exploratory mediator - excitability-inhibitory (E/I) ratio
timeFrame: First day of intervention,1 day after the last day of intervention (2 time points, up to 2 weeks)
Locations:
city: Hung Hom
country: Hong Kong
facility: The Hong Kong Polytechnic University
state: Kowloon
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Yvonne Han, PhD
role: PRINCIPAL_INVESTIGATOR
References: