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

NCT06376500 | Recruiting

• 1 other identifier: HSEARS20240223001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcranial Direct Current Stimulation; Post-Concussion Syndrome; Functional Magnetic Resonance Imaging; Magnetic Resonance Spectroscopy

Outcome Measures

Primary Outcomes (1)

• Average standardised score of executive function tests

  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.

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

Secondary Outcomes (3)

• 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)

Other Outcomes (2)

• Exploratory mediator - default mode network (DMN) activation

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

• Exploratory mediator - excitability-inhibitory (E/I) ratio

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

Study Arms (2)

Active-tDCS

EXPERIMENTAL

For active-tDCS condition, participants will receive stimulation on the dorsolateral prefrontal cortex with ramp up and ramp down mode for 10 seconds, eliciting a tingling sensation on the scalp that fades over seconds.

Device: tDCS with cognitive training programme

Sham-tDCS

SHAM COMPARATOR

For sham-tDCS condition, participants will receive initial stimulation with ramp up and ramp down mode for 30 seconds, eliciting a tingling sensation on the scalp then it will be discontinued.

Device: tDCS with cognitive training programme

Interventions

tDCS with cognitive training programme DEVICE

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.

Active-tDCS; Sham-tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

Post-Concussion Syndrome

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Yvonne Han, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvonne Han, PhD

CONTACT

+852 2766 7578; yvonne.han@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 19, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 19, 2025

Record last verified: 2025-03

Locations

HK (1)