Clinical Trials Directory

Trials / Completed

CompletedNCT05311982

Transcranial Direct Current Stimulation in Autistic Spectrum Disorder

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
12 (actual)
Sponsor
Federal University of Paraíba · Academic / Other
Sex
All
Age
5 Years – 18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICEDLPFC-R (F4) TDCSdirect 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.
DEVICEDLPFC-L (F3) and DLPFC-R (F4) TDCSDLPFC-L (F3) and DLPFC-R (F4) (Bock B)
DEVICEsham-tDCSsham-tDCS (Block C) with equal electrode configuration guaranteed blindness

Timeline

Start date
2021-03-01
Primary completion
2021-07-30
Completion
2021-09-30
First posted
2022-04-05
Last updated
2022-04-05

Locations

2 sites across 1 country: Brazil

Source: ClinicalTrials.gov record NCT05311982. Inclusion in this directory is not an endorsement.