Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Efectos de la tDCS para mejorar la función cognitiva en personas con síndrome persistente posconmoción cerebral

24 de septiembre de 2026 actualizado por: Dr Yvonne Han, The Hong Kong Polytechnic University

Efectos de la estimulación transcraneal por corriente directa para mejorar la función cognitiva en personas con síndrome persistente posconmoción cerebral: un estudio 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

40

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Kowloon
      • Hung Hom, Kowloon, Hong Kong
        • Reclutamiento
        • The Hong Kong Polytechnic University
        • Contacto:
          • Yvonne Han, PhD
          • Número de teléfono: +852 2766 7578

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Average standardised score of executive function tests
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in CANTAB® cognitive test - Reaction Time (RTI)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Exploratory mediator - default mode network (DMN) activation
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de septiembre de 2025

Finalización primaria (Estimado)

1 de agosto de 2027

Finalización del estudio (Estimado)

1 de febrero de 2028

Fechas de registro del estudio

Enviado por primera vez

8 de abril de 2024

Primero enviado que cumplió con los criterios de control de calidad

18 de abril de 2024

Publicado por primera vez (Actual)

19 de abril de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • HSEARS20240223001

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .