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Conectividad funcional en estado de reposo como predictor de efectos de TDCS en adolescentes con trastorno del espectro autista

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

Background: Transcranial Direct Current Stimulation (tDCS) is a form of non-invasive brain stimulation that has aroused increased interests in the past decade. Not only that it is transient with little side-effects, and can be well-tolerated by children, it is also affordable and readily accessible, making it an appealing treatment option for autism spectrum disorder (ASD).

Objective: (1) To evaluate the therapeutic effects of tDCS on improving cognitive function in patients with ASD, (2) to better understand the neural mechanisms underlying the neuromodulation effects of tDCS in patients with ASD, and (3) to determine whether resting-state functional connectivity measures can predict the therapeutic effects of active tDCS in individuals with ASD.

Methods: To assess the therapeutic effects and neural mechanisms of tDCS, 90 adolescents with ASD (age 12-22 years) will receive three stimulation conditions: cathodal tDCS of the left DLPFC, anodal tDCS of the left DLPFC and sham-tDCS with at least a week apart each time. During the active tDCS or sham-tDCS condition, the participants will be administered a computerized test battery (Cambridge Neuropsychological Test Automated Battery, CANTAB®) to evaluate their cognitive function. EEG before and after the tDCS to evaluate the tDCS-induced alteration in their neural activity and functional connectivity.

Hypothesis: Drawing together the different evidence linking ASD with cortical hyper-excitability and disordered neural connectivity, as reviewed previously, the investigators hypothesize that, relative to a sham-tDCS condition, active cathodal (inhibitory) and anodal (excitatory) tDCS over the left DLPRC will induce stimulation-linked facilitation of learning and resultant improvement of cognitive functioning in patients with ASD.

In addition to the therapeutic effects of tDCS, enhanced neural connectivity, as indexed by altered level EEG theta coherence in patients with ASD, will mediate the beneficial effects of tDCS, relative to sham tDCS, on improvements in cognitive function. Moreover, resting-state functional connectivity will moderate the beneficial effects of active tDCS on cognitive function, relative to sham tDCS, such that participants with greater pre-treatment resting state functional connectively will evidence greater/less response to tDCS, relative to participants receiving sham tDCS.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

90

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

12 años a 22 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • being 12-22 years old
  • diagnosed with ASD given by registered psychiatrists or clinical psychologists according to the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) criteria of ASD
  • able to communicate in Chinese

Exclusion Criteria:

  • without a confirmed diagnosis from the clinical psychologist
  • history of other neurological and psychiatric disorders and head trauma
  • on psychiatric medication

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 cruzada
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Cathodal active tDCS

For cathodal tDCS condition, participants will receive cathodal 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. Following that, a twenty-minute executive functional task will be initiated five minutes subsequent to the stimulation mode, and the stimulation will be terminated when the task ends.

Participant will receive three stimulation conditions: cathodal tDCS of the left DLPFC, anodal tDCS of the left DLPFC and sham-tDCS. The order of the conditions will be randomized and counterbalanced across participants, and the three stimulation conditions will be administered at least a week apart to avoid carry-over effects. The tDCS session will last for 20 minutes.

Experimental: Anodal active tDCS

For anodal tDCS condition, participants will receive anodal 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. Following that, a twenty-minute executive functional task will be initiated five minutes subsequent to the stimulation mode, and the stimulation will be terminated when the task ends.

Participant will receive three stimulation conditions: cathodal tDCS of the left DLPFC, anodal tDCS of the left DLPFC and sham-tDCS. The order of the conditions will be randomized and counterbalanced across participants, and the three stimulation conditions will be administered at least a week apart to avoid carry-over effects. The tDCS session will last for 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. Participant will also receive the twenty-minute executive functional task five minutes subsequent to the stimulation mode.

Participant will receive three stimulation conditions: cathodal tDCS of the left DLPFC, anodal tDCS of the left DLPFC and sham-tDCS. The order of the conditions will be randomized and counterbalanced across participants, and the three stimulation conditions will be administered at least a week apart to avoid carry-over effects. The tDCS session will last for 20 minutes.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in CANTAB® cognitive test - Reaction Time (RTI)
Periodo de tiempo: During each stimulation session, last around 3mins

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.

During each stimulation session, last around 3mins
Change in CANTAB® cognitive test - Spatial Working Memory (SWM)
Periodo de tiempo: During each stimulation session, last around 6mins

SWM assesses retention and manipulation of visuospatial information. The participant should find one yellow "token" in each of a number of boxes and use them to fill up an empty column on the right of the screen by selecting the boxes and using a process of elimination. Error selecting boxes that have already been found to be empty and revisiting boxes which have already been found to contain a token will be measured.

During each stimulation session, last around 6mins
Change in CANTAB® cognitive test - Multitasking Test (MTT): Response Latencies
Periodo de tiempo: During each stimulation session, last around 8mins

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 will be measured.

During each stimulation session, last around 8mins
Change in CANTAB® cognitive test - Multitasking Test (MTT): Error Scores
Periodo de tiempo: During each stimulation session, last around 8mins

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 error scores will be measured.

During each stimulation session, last around 8mins
Changes in EEG theta coherence
Periodo de tiempo: Before tDCS session, Right after tDCS session (2 timepoints, up to 20 minutes)

Each participant will be tested individually to collect EEG data. The participants' eyes-open resting condition will be assessed by EEG for 5 minutes, before and after the tDCS to evaluate the tDCS-induced alteration in their neural activity and functional connectivity. Raw data will be processed with the EEGLAB Toolbox using MATLAB® R2019a. Data from 19 electrodes will be used for analysis.

Before tDCS session, Right after tDCS session (2 timepoints, up to 20 minutes)

Colaboradores e Investigadores

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

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 abril de 2027

Finalización del estudio (Estimado)

1 de abril de 2027

Fechas de registro del estudio

Enviado por primera vez

11 de marzo de 2025

Primero enviado que cumplió con los criterios de control de calidad

11 de marzo de 2025

Publicado por primera vez (Actual)

14 de marzo de 2025

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

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. .

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