Transcranial Direct Current Stimulation in Autistic Spectrum Disorder

Study Overview
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Brief Summary
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To understand the changes in the resting electroencephalogram (EEG) brain networks of children and adolescents with autistic spectrum disorder (ASD) induced by transcranial direct current stimulation (tDCS), we asked two questions. First: how can tDCS modulate the expression of neural network dynamics? Second: how can tDCS modulate functional connections at specific frequencies? We hypothesized that the tDCS mechanism results in increased cortical frequencies in the areas under the anode, which may reflect an increase in synaptic connectivity, and that this tDCS-related increase changes connection profiles at specific frequencies important for ASD, indicating improvement in symptoms. To verify this improvement, the researchers used the Autism Treatment Evaluation Checklist (ATEC) after an intervention, comparing baseline scores with post-treatment scores.

Official Title
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Transcranial Direct Current Stimulation Modulates Spectral Power and Coherence in Autism Spectrum Disorder: a Triple-blind, Placebo-controlled Study

Conditions
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Autistic Disorders Spectrum

Intervention / Treatment
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* Device: DLPFC-R (F4) TDCS
* Device: DLPFC-L (F3) and DLPFC-R (F4) TDCS
* Device: sham-tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ASD reported by a Neuropediatrician; Age group between 5 and 18 years; Mild and moderate clinical symptoms Exclusion Criteria: Patients with severe mental illness; Use of a pacemaker or other metal device on the body; Brain tumor or intracranial infection; Uncooperative parents or caregivers; Epilepsy; structural change in the skull

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DLPFC-L F3 (Block A)<br>The study was developed through a triple-blind, crossover, randomized, placebo-controlled clinical trial (dummy tDCS). Participants were randomized into three groups receiving unilateral tDCS in DLPFC-L F3 (Block A) | Device: DLPFC-R (F4) TDCS<br>* direct current brain stimulation- The study was developed through a triple-blind, crossover, randomized, placebo-controlled clinical trial (dummy tDCS). Participants were randomized into three groups receiving unilateral tDCS in DLPFC-L F3 (Block A), combined tDCS in DLPFC-L (F3) and DLPFC-R (F4) simultaneously (Block B) or sham-tDCS (Block C) with equal electrode configuration guaranteed blindness. After the procedures, each participant received the following intervention in the order ABC, BCA or CAB with a period of 1 week between each one. Each block took 3 weeks, organized into: 1) Assessment; 2) Application of stimulation; 3) Reassessment and washout week. Adding 1 more week of final evaluation, the study totaled the period of 10 weeks. During this period, patients were instructed to continue their behavioral/educational treatment and medication routines.<br>Device: DLPFC-L (F3) and DLPFC-R (F4) TDCS<br>* DLPFC-L (F3) and DLPFC-R (F4) (Bock B)<br>* Other names: nibs;Device: sham-tDCS<br>* sham-tDCS (Block C) with equal electrode configuration guaranteed blindness<br>* Other names: NIBS;|
| Active Comparator: tDCS combined in DLPFC-L (F3) and DLPFC-R (F4)<br>The study was developed through a triple-blind, crossover, randomized, placebo-controlled clinical trial (dummy tDCS). Participants were randomized into three groups receiving unilateral tDCS in tDCS combined in DLPFC-L (F3) and DLPFC-R (F4) | Device: DLPFC-R (F4) TDCS<br>* direct current brain stimulation- The study was developed through a triple-blind, crossover, randomized, placebo-controlled clinical trial (dummy tDCS). Participants were randomized into three groups receiving unilateral tDCS in DLPFC-L F3 (Block A), combined tDCS in DLPFC-L (F3) and DLPFC-R (F4) simultaneously (Block B) or sham-tDCS (Block C) with equal electrode configuration guaranteed blindness. After the procedures, each participant received the following intervention in the order ABC, BCA or CAB with a period of 1 week between each one. Each block took 3 weeks, organized into: 1) Assessment; 2) Application of stimulation; 3) Reassessment and washout week. Adding 1 more week of final evaluation, the study totaled the period of 10 weeks. During this period, patients were instructed to continue their behavioral/educational treatment and medication routines.<br>Device: DLPFC-L (F3) and DLPFC-R (F4) TDCS<br>* DLPFC-L (F3) and DLPFC-R (F4) (Bock B)<br>* Other names: nibs;Device: sham-tDCS<br>* sham-tDCS (Block C) with equal electrode configuration guaranteed blindness<br>* Other names: NIBS;|
| No Intervention: Sham (Block C)<br>The study was developed through a triple-blind, crossover, randomized, placebo-controlled clinical trial (dummy tDCS). Participants were randomized into three groups receiving unilateral tDCS in tDCS Sham | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to compare the effectiveness of Neuromodulation techniques - transcranial direct current stimulation (tDCS) - in the treatment of people with Autism Spectrum Disorder | EEG and TDCS | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Check the effects of tDCS modulations on cognitive responses through Autism Treatment Evaluation Checklist | ATEC and EEG | 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism, Tdcs, EEG