Autistic Disorders SpectrumTDCSinASDNCT05311982
Transcranial Direct Current Stimulation in Autistic Spectrum Disorder
A study testing DLPFC-R (F4) TDCS and DLPFC-L (F3) and DLPFC-R (F4) TDCS in people with Autistic Disorders Spectrum, run by Federal University of Paraíba at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Autistic Disorders Spectrum
- What is being tested?
- DLPFC-R (F4) TDCS and DLPFC-L (F3) and DLPFC-R (F4) TDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Mar 2021to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with ASD reported by a Neuropediatrician; Age group between 5 and 18 years; Mild and moderate clinical symptoms
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Suellen Marinho Andrade
João Pessoa, Paraíba, 58.051-900
Federal University of Paraíba,Department of Psychology
João Pessoa, Paraíba, 58051-900
About this study
Official title: Transcranial Direct Current Stimulation Modulates Spectral Power and Coherence in Autism Spectrum Disorder: a Triple-blind, Placebo-controlled Study
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
- Autistic Disorders Spectrum
- Being tested
- DLPFC-R (F4) TDCS, DLPFC-L (F3) and DLPFC-R (F4) TDCS, sham-tDCS
- Keywords
- Autism, Tdcs, EEG
- Medical subject headings
- Child Development Disorders, Pervasive, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLPFC-R (F4) TDCSDevice
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) TDCSDevice
Also called nibs
DLPFC-L (F3) and DLPFC-R (F4) (Bock B)
sham-tDCSDevice
Also called NIBS
sham-tDCS (Block C) with equal electrode configuration guaranteed blindness
| Study group | Role | What they receive |
|---|---|---|
| DLPFC-L F3 (Block A) | Active comparator | 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) Receives: Device: DLPFC-R (F4) TDCS; Device: DLPFC-L (F3) and DLPFC-R (F4) TDCS; Device: sham-tDCS |
| tDCS combined in DLPFC-L (F3) and DLPFC-R (F4) | Active comparator | 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) Receives: Device: DLPFC-R (F4) TDCS; Device: DLPFC-L (F3) and DLPFC-R (F4) TDCS; Device: sham-tDCS |
| Sham (Block C) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
to compare the effectiveness of Neuromodulation techniques - transcranial direct current stimulation (tDCS) - in the treatment of people with Autism Spectrum Disorder
EEG and TDCS
Measured: 7 weeks
Secondary outcomes (1)
Check the effects of tDCS modulations on cognitive responses through Autism Treatment Evaluation Checklist
ATEC and EEG
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Mar 2021
- Primary completion30 Jul 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic Disorders SpectrumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suellen Marinho Andrade, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311982
- Sponsor's protocol ID
- Tdcs Autism ufpb
- Acronym
- TDCSinASD
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation Modulates Spectral Power and Coherence in Autism Spectrum Disorder: a Triple-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05311982
- Acronym / sponsor ID
- TDCSinASD / Tdcs Autism ufpb
- Conditions
- Autistic Disorders Spectrum
- Keywords
- Autism, Tdcs, EEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DLPFC-L F3 (Block A) | Active comparator | Device: DLPFC-R (F4) TDCS, Device: DLPFC-L (F3) and DLPFC-R (F4) TDCS, Device: sham-tDCSThe 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 comparator | Device: DLPFC-R (F4) TDCS, Device: DLPFC-L (F3) and DLPFC-R (F4) TDCS, Device: sham-tDCSThe 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 intervention | –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 |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with ASD reported by a Neuropediatrician; Age group between 5 and 18 years; Mild and moderate clinical symptoms
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DLPFC-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. | Device | DLPFC-L F3 (Block A), tDCS combined in DLPFC-L (F3) and DLPFC-R (F4) |
| DLPFC-L (F3) and DLPFC-R (F4) TDCSAlso: nibsDLPFC-L (F3) and DLPFC-R (F4) (Bock B) | Device | DLPFC-L F3 (Block A), tDCS combined in DLPFC-L (F3) and DLPFC-R (F4) |
| sham-tDCSAlso: NIBSsham-tDCS (Block C) with equal electrode configuration guaranteed blindness | Device | DLPFC-L F3 (Block A), tDCS combined in DLPFC-L (F3) and DLPFC-R (F4) |
Primary outcome
to compare the effectiveness of Neuromodulation techniques - transcranial direct current stimulation (tDCS) - in the treatment of people with Autism Spectrum Disorder
Time frame: 7 weeks
EEG and TDCS
1 secondary outcome
Check the effects of tDCS modulations on cognitive responses through Autism Treatment Evaluation Checklist
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DLPFC-R (F4) TDCS and DLPFC-L (F3) and DLPFC-R (F4) TDCS in people with Autistic Disorders Spectrum, run by Federal University of Paraíba at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to compare the effectiveness of Neuromodulation techniques - transcranial direct current stimulation (tDCS) - in the treatment of people with Autism Spectrum Disorder (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.