Transcranial Direct Current Stimulation in Autistic Spectrum Disorder
TDCSinASD
1 other identifier
interventional
12
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedFirst Submitted
Initial submission to the registry
March 16, 2022
CompletedFirst Posted
Study publicly available on registry
April 5, 2022
CompletedApril 5, 2022
March 1, 2022
5 months
March 16, 2022
March 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Check the effects of tDCS modulations on cognitive responses through Autism Treatment Evaluation Checklist
7 weeks
Study Arms (3)
DLPFC-L F3 (Block A)
ACTIVE COMPARATORThe 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)
tDCS combined in DLPFC-L (F3) and DLPFC-R (F4)
ACTIVE COMPARATORThe 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)
Sham (Block C)
NO INTERVENTIONThe 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
Interventions
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.
DLPFC-L (F3) and DLPFC-R (F4) (Bock B)
sham-tDCS (Block C) with equal electrode configuration guaranteed blindness
Eligibility Criteria
You may qualify if:
- Patients with ASD reported by a Neuropediatrician; Age group between 5 and 18 years; Mild and moderate clinical symptoms
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Suellen Marinho Andrade
João Pessoa, Paraíba, 58.051-900, Brazil
Federal University of Paraíba,Department of Psychology
João Pessoa, Paraíba, 58051-900, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 16, 2022
First Posted
April 5, 2022
Study Start
March 1, 2021
Primary Completion
July 30, 2021
Study Completion
September 30, 2021
Last Updated
April 5, 2022
Record last verified: 2022-03