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Transcranial Direct Current Stimulation in Autistic Spectrum Disorder (TDCSinASD)

Primary Purpose

Autistic Disorders Spectrum

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
DLPFC-R (F4) TDCS
DLPFC-L (F3) and DLPFC-R (F4) TDCS
sham-tDCS
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Disorders Spectrum focused on measuring Autism, Tdcs, EEG

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Paraíba,Department of Psychology
  • Suellen Marinho Andrade

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

DLPFC-L F3 (Block A)

tDCS combined in DLPFC-L (F3) and DLPFC-R (F4)

Sham (Block C)

Arm Description

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)

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)

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

Outcomes

Primary Outcome Measures

to compare the effectiveness of Neuromodulation techniques - transcranial direct current stimulation (tDCS) - in the treatment of people with Autism Spectrum Disorder
EEG and TDCS

Secondary Outcome Measures

Check the effects of tDCS modulations on cognitive responses through Autism Treatment Evaluation Checklist
ATEC and EEG

Full Information

First Posted
March 16, 2022
Last Updated
March 28, 2022
Sponsor
Federal University of Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT05311982
Brief Title
Transcranial Direct Current Stimulation in Autistic Spectrum Disorder
Acronym
TDCSinASD
Official Title
Transcranial Direct Current Stimulation Modulates Spectral Power and Coherence in Autism Spectrum Disorder: a Triple-blind, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorders Spectrum
Keywords
Autism, Tdcs, EEG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DLPFC-L F3 (Block A)
Arm Type
Active Comparator
Arm Description
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)
Arm Title
tDCS combined in DLPFC-L (F3) and DLPFC-R (F4)
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Sham (Block C)
Arm Type
No Intervention
Arm Description
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
Intervention Type
Device
Intervention Name(s)
DLPFC-R (F4) TDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
DLPFC-L (F3) and DLPFC-R (F4) TDCS
Other Intervention Name(s)
nibs
Intervention Description
DLPFC-L (F3) and DLPFC-R (F4) (Bock B)
Intervention Type
Device
Intervention Name(s)
sham-tDCS
Other Intervention Name(s)
NIBS
Intervention Description
sham-tDCS (Block C) with equal electrode configuration guaranteed blindness
Primary Outcome Measure Information:
Title
to compare the effectiveness of Neuromodulation techniques - transcranial direct current stimulation (tDCS) - in the treatment of people with Autism Spectrum Disorder
Description
EEG and TDCS
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Check the effects of tDCS modulations on cognitive responses through Autism Treatment Evaluation Checklist
Description
ATEC and EEG
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Federal University of Paraíba,Department of Psychology
City
João Pessoa,
State/Province
Paraiba
ZIP/Postal Code
58051-900
Country
Brazil
Facility Name
Suellen Marinho Andrade
City
João Pessoa
State/Province
Paraíba
ZIP/Postal Code
58.051-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Transcranial Direct Current Stimulation in Autistic Spectrum Disorder

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