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Transcranial Direct Current Stimulation in Autism Spectrum Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03814083
Recruitment Status : Not yet recruiting
First Posted : January 23, 2019
Last Update Posted : May 8, 2019
Sponsor:
Collaborator:
Chinese University of Hong Kong
Information provided by (Responsible Party):
Dr Yvonne Han, The Hong Kong Polytechnic University

Brief Summary:

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 assess the therapeutic effects of tDCS when combined with cognitive training for 10 consecutive weekdays on improving cognitive processing in adolescents with ASD, relative to control group receiving sham-stimulation, and (2) to evaluate the associated neural mechanisms underlying the treatment effect of tDCS on adolescents with ASD.

Methods: 90 adolescents with ASD will be randomly assigned to active- (n=30), sham- (n=30) tDCS, or no-treatment control (n=30) groups. Twenty minute sessions of 1 mA cathodal stimulation to the left dorsolateral prefrontal cortex (DLPRC) in conjunction with cognitive training exercise will be provided on 10 consecutive weekdays. EEGs, functional near-infrared spectroscopy, and neuropsychological tests will be administered before, 1 day and 6 months after the series of tDCS sessions.

Hypothesis: We hypothesized that cathodal (inhibitory) tDCS over the left DLPRC will induce (1) stimulation-linked facilitation of learning and enhanced processing speed and resultant improvement of cognitive functioning, in executive function, relative to the sham-tDCS and the wait-list controls, (2) active-tDCS, but not sham-tDCS and wait-list controls, will modulate the intra- and inter-hemispheric neural connectivity, indexed by altered level EEG theta coherence and aberrant fNIRS haemodynamic measures, across brain areas implicated in executive functioning.


Condition or disease Intervention/treatment Phase
Transcranial Direct Current Stimulation Autistic Disorders Spectrum Electroencephalography Device: Active-tDCS Device: Sham-tDCS Other: Wait-list Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Transcranial Direct Current Stimulation for Enhancing Cognitive Function in Children With Autism Spectrum Disorder
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active-tDCS and Sham-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. Following that, a twenty-minute executive functional training task will be initiated five minutes subsequent to the stimulation mode, and the stimulation will be terminated when the training task ends. On the other hand, 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 training task five minutes subsequent to the stimulation mode.
Device: Active-tDCS
Active-tDCS over 10 sessions in 2 weeks (once per day, for 10 consecutive working days), while performing the executive function training tasks. Also, participants will complete an online cognitive training program while they receive active tDCS stimulation for 10 training sessions. The training session will last for 20 minutes and the online cognitive training program 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.

Device: Sham-tDCS
Sham-tDCS stimulation over 10 sessions in 2 weeks (once per day, for 10 consecutive working days), while performing the executive function training tasks. Also, participants will complete an online cognitive training program while they receive sham-tDCS stimulation for 10 training sessions. The training session will last for 20 minutes and the online cognitive training program 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 Comparator: Active-tDCS and wait-list
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. Following that, a twenty-minute executive functional training task will be initiated five minutes subsequent to the stimulation mode, and the stimulation will be terminated when the training task ends. On the other hand, participants in the wait-list control group will not receive any intervention.
Device: Active-tDCS
Active-tDCS over 10 sessions in 2 weeks (once per day, for 10 consecutive working days), while performing the executive function training tasks. Also, participants will complete an online cognitive training program while they receive active tDCS stimulation for 10 training sessions. The training session will last for 20 minutes and the online cognitive training program 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.

Other: Wait-list
No intervention

Sham Comparator: Sham-tDCS and wait-list
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 training task five minutes subsequent to the stimulation mode. On the other hand, participants in the wait-list control group will not receive any intervention.
Device: Sham-tDCS
Sham-tDCS stimulation over 10 sessions in 2 weeks (once per day, for 10 consecutive working days), while performing the executive function training tasks. Also, participants will complete an online cognitive training program while they receive sham-tDCS stimulation for 10 training sessions. The training session will last for 20 minutes and the online cognitive training program 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.

Other: Wait-list
No intervention




Primary Outcome Measures :
  1. Change in behavioral measures - Early Adolescent Temperament Questionnaire - Revised - Effortful control subscale (EATQ-R-EC) [ Time Frame: First day of intervention,1 day and 6 months after the last day of intervention (3 time points) ]
    EATQ-R-EC is an 18-item self-rated questionnaire composed of 3 sub-components under effortful control, namely attentional control, inhibitory control and activation control.

  2. Change in behavioral measures - Autism Quotient (AQ) [ Time Frame: First day of intervention,1 day and 6 months after the last day of intervention (3 time points) ]
    AQ serves as a screening test for autism spectrum disorders. Given its sensitivity to subtle autistic features, it is thus adopted in present study to rule out possibilities of children having unidentified autism. The questionnaire is rated on a 4-point Likert scale, from 0 (definitely agree) to 3 (definitely disagree) on a total of 50 items. Higher scores suggest greater severity level of autistic features.

  3. Change in behavioral measures - Social Responsiveness Scales (SRS) [ Time Frame: First day of intervention,1 day and 6 months after the last day of intervention (3 time points) ]
    SRS-2 for measures participants' social communication abilities that are highly related to frontal lobe dysfunction. It is a 4-point scale tapping on the aspects of social awareness, social cognition, social communication, social motivation, and restricted interests and repetitive behavior. Higher scores indicate greater difficulties in socialization.

  4. Change in CANTAB® cognitive test - Stop Signal Task (SST) [ Time Frame: First day of intervention,1 day and 6 months after the last day of intervention (3 time points) ]
    Cambridge Neuropsychological Test Automated Battery (CANTAB®) includes computerized tests correlated to neural networks and have demonstrated high sensitivity in detecting changes in neuropsychological performance. SST assesses a participants' motor inhibition of a prepotent response. The participant is required to respond to an arrow stimulus by selecting one of two options, depending on the direction in which the arrow points. If an audio tone is present, the subject must withhold making the response.

  5. Change in CANTAB® cognitive test - Reaction Time (RTI) [ Time Frame: First day of intervention,1 day and 6 months after the last day of intervention (3 time points) ]
    RTI assesses motor and mental response speeds, reaction time, response accuracy and impulsivity. Participants are required to react as soon as a yellow dot appears on screen. Specifically, movement and reaction time will be measured, where shorter duration reflects faster processing speed.

  6. Change in CANTAB® cognitive test - One Touch Stockings of Cambridge (OTS) [ Time Frame: First day of intervention,1 day and 6 months after the last day of intervention (3 time points) ]
    OTS assesses the spatial planning ability. The participant is required to determine the number of steps required to move the balls such that the pattern copies the desired patterns (correct answer). The OTS comprises of 4 problem sets to reflect increasing demands on planning.

  7. Change in CANTAB® cognitive test - Multitasking Test (MTT) [ Time Frame: First day of intervention,1 day and 6 months after the last day of intervention (3 time points) ]
    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.

  8. Change in CANTAB® cognitive test - Emotion Recognition Task (ERT) [ Time Frame: First day of intervention,1 day and 6 months after the last day of intervention (3 time points) ]
    ERT assesses emotional recognition ability of an individual. The participant is required to determine the emotion of the face displayed from 6 options (i.e. sadness, happiness, fear, anger, disgust or surprise) after viewing the facial features of real individuals for 200 milliseconds.

  9. Change in n-back task [ Time Frame: First day of intervention,1 day and 6 months after the last day of intervention (3 time points) ]
    The N-back paradigm consists of 0-back (i.e., low working memory load), 1-back (i.e., medium working memory load), and 2-back (i.e., high working memory load) conditions. For the 0-back condition, participants have to press the left button of a mouse when the digit "0" (i.e., target) appeared whereas to press the right button for occurrence of other digits. For 1-back condition, participants are required to press the left button when the presented digit was identical to the one presented in the previous trial (i.e., target), otherwise, press the right button. For 2-back condition, participants are required to press the left button when the presented digit was identical to the one presented two trials before (i.e., target), otherwise, press the right button. The accuracy rate and reaction time of each block across different conditions will be measured to reflect the capacity of working memory and processing speed.

  10. Change in the Attention Network Task (ANT) [ Time Frame: First day of intervention,1 day and 6 months after the last day of intervention (3 time points) ]
    The computerized ANT paradigm measures different levels of attention network, namely alerting, orienting and conflicting monitoring. To measure alerting and/or orienting, 3 warning conditions will be presented - no-cue (baseline), center-cue (alerting) and spatial-cue (alerting plus orienting). Stimuli consisted of a row of 5 objects, with the object in the center being an arrow pointing either to the left or right, and 4 remaining objects being diamond-shaped stimuli. To assess conflict monitoring, the central arrow will be "flanked by congruent or incongruent stimuli". The target is flanked on either side by two arrows in the same direction (congruent) or in the opposite direction (incongruent). The participants are required to identify the direction of the arrow presented in the middle by pressing the left and right button respectively. Reaction times will be calculated to reflect subjects' performance.

  11. Change in Electroencephalography (EEG) coherence measure [ Time Frame: First day of intervention,1 day and 6 months after the last day of intervention (3 time points) ]
    EEG coherence measure is a useful indicator of cortical connectivity between functional areas in the brain. It reflects the levels of synchronization between two cortical areas at different sites of the scalp. High coherence indicates a high level of synchronization between the two brain areas, whereas low coherence indicates a low level of synchronization. It has been shown that different EEG frequency bands correlate with different cognitive and emotional processes. EEG signals collected from the 19 electrode positions (Fp1, Fp2, F3, F4, F7, F8, Fz, T3, T4, T5, T6, C3, C4, Cz, P3, P4, Pz, O1, and O2) will be used.

  12. Change in functional near-infrared spectroscopy (fNIRS) recording [ Time Frame: First day of intervention,1 day and 6 months after the last day of intervention (3 time points) ]
    NIRS is a non-invasive neuroimaging procedure used to measure hemodynamic changes, in terms of oxyhemoglobin (HbO), deoxyhemoglobin (HbR) and total haemoglobin (HbT), associated with neuronal activities of the cerebral cortex in response to attending a task within a given period of time. In addition, functional connectivity will be measured, in which the synchronized responses to cognitive stimuli between and within the left and right frontal cortex will be computed in terms of zero lagged correlation. During the NIRS session, participants will be tested on the Attention Network Task (ANT), and the n-back task while their hemodynamic data are collected using the NIRS system.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals who are confirmed by a clinical psychologist based on the Diagnostic and Statistical Manual of Mental Disorders-5th Ed (DSM-V) criteria of Autism spectrum disorder and structured interview with their parents or primary caregivers on their developmental history using the Autism Diagnostic Interview-Revised (ADI-R).
  • Individuals with intelligence quotient above 70
  • Individuals who demonstrate the ability to comprehend testing and stimulation instructions

Exclusion Criteria:

  • Individuals with severe motor dysfunctions that would hinder their participation, and those with history of other neurological and psychiatric disorders and head trauma, or on psychiatric medication will be excluded from the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03814083


Contacts
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Contact: Yvonne Han 2766 7578 yvonne.han@polyu.edu.hk

Sponsors and Collaborators
The Hong Kong Polytechnic University
Chinese University of Hong Kong

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Responsible Party: Dr Yvonne Han, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03814083    
Other Study ID Numbers: HSEARS20171230001
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders