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Efeitos da ETCC para melhorar a função cognitiva em indivíduos com síndrome pós-concussão persistente

24 de setembro de 2026 atualizado por: Dr Yvonne Han, The Hong Kong Polytechnic University

Efeitos da estimulação transcraniana por corrente contínua para melhorar a função cognitiva em indivíduos com síndrome pós-concussão persistente: um estudo piloto fMRI/1H-MRS

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

40

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • Kowloon
      • Hung Hom, Kowloon, Hong Kong
        • Recrutamento
        • The Hong Kong Polytechnic University
        • Contato:
          • Yvonne Han, PhD
          • Número de telefone: +852 2766 7578

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Active-tDCS

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.

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.

Comparador Falso: Sham-tDCS

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.

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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Average standardised score of executive function tests
Prazo: 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.

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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in CANTAB® cognitive test - Reaction Time (RTI)
Prazo: First day of intervention,1 day after the last day of intervention (2 time points, up to 2 weeks)

RTI assesses motor and mental response speeds, reaction time, response accuracy and impulsivity. It consists of 30 trials with five potential targets and requires participants to make flexible responses as fast as possible to the target stimulus (shown in yellow). Specifically, movement and reaction time will be measured, where shorter duration reflects faster processing speed.

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

MTT assesses the ability to resolve the interference of task-irrelevant information (stroop-like effect). The test displays an arrow which can appear on either the left or right side of the screen and can point to either the left or right side. In each trial, participants are presented with a cue that indicates which button to press according to two different rules. And the rules that participants have to follow may change from trial to trial in a randomized order. Participant's response latencies and error scores will be measured.

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

SWM assess the memory ability of visuospatial information. Participants are required to search the tokens from a number of boxes but not pressing the boxes which tokens have been found. Errors (lower scores indicate lower repetition on pressing the same boxes that token has been found) and strategy (lower scores suggest higher strategy use in begin of choosing the same boxes) will be measured.

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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Exploratory mediator - default mode network (DMN) activation
Prazo: First day of intervention,1 day after the last day of intervention (2 time points, up to 2 weeks)

The DMN activation, indexed by fMRI resting state data will be assessed. Neuroimaging data will be acquired from the whole brain using a 64-channel head coil on a 3T Siemens MRI scanner. Resting-state data will be registered to each participant's high-resolution structural image and then normalized into the standard Montreal Neurological Institute (MNI) space. Mediation analyses will be performed to determine if the enhanced network organization in PCS patients, as indexed by DMN activation, will mediate the beneficial effect of tDCS

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

The E/I ratio, indexed by MRS data will be assessed. The MRS acquisition protocol is adopted from Sapey-Triomphe and the colleagues. Magnetic resonance spectra will be acquired using the Hadamard Encoding and Reconstruction of MEGA-Edited Spectroscopy (HERMES) sequence, allowing for simultaneous quantification of GABA + and Glx (glutamine and glutamate). The MRS acquisition parameters will be set as follows: 320 averages, TR = 2000 ms, TE = 80 ms, 2048 data points, 2000 Hz spectral width, MOIST water suppression, 90°excitation/180°refocusing pulses, 20 ms editing pulses at frequencies 1.9 ppm for GABA. Interleaved Water Reference correction will be used to limit the effect of scanner drift. Twenty unsuppressed water reference scans (at TE = 80 ms) will also be acquired. Mediation analyses will be performed to determine if the enhanced network organization in PCS patients, as indexed by E/I balance, will mediate the beneficial effect of tDCS

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Yvonne Han, PhD, The Hong Kong Polytechnic University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de setembro de 2025

Conclusão Primária (Estimado)

1 de agosto de 2027

Conclusão do estudo (Estimado)

1 de fevereiro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

8 de abril de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de abril de 2024

Primeira postagem (Real)

19 de abril de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • HSEARS20240223001

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .