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
| Type | Name | Description |
|---|---|---|
| DEVICE | DLPFC-R (F4) TDCS | 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. |
| DEVICE | DLPFC-L (F3) and DLPFC-R (F4) TDCS | DLPFC-L (F3) and DLPFC-R (F4) (Bock B) |
| DEVICE | sham-tDCS | sham-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.