Autism Spectrum DisorderNCT05105126
Non-invasive Brain Stimulation in Children With Autism
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Autism Spectrum Disorder and Executive Dysfunction, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Although many children diagnosed with autism spectrum disorder (ASD) make significant progress in learning and their cognitive skills improve with applied behavior analysis (ABA), there are a significant number of children who show an absence or a plateau in various skills. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder, Executive Dysfunction, Child Autism
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 14 Feb 2024
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females between 5 and 12 years with autism
- Enrolled in an ABA program (school or in-home) supervised by a Board Certified Behavior Analyst (BCBA)
- Stable medical and behavioral treatments for at least 4 weeks prior to, and during the study
- Able to tolerate wearing tDCS as determined during a week-long daily desensitization training.
Who cannot join
- Any implanted metal device (heart pacemaker, cochlear implant, surgical clips, etc.)
- Severe neurological disorders such as TBI, brain tumor, intracranial infection
- Seizure disorder with a seizure within the last two years
- Skull defect
- Peripheral blindness or deafness
- Medication that might affect tDCS: There have been a few studies concerning the effect of various medications on tDCS. Some may block and others may enhance the effects depending on many factors. The assay used to test these medications was its effect on the motor cortex after stimulation and this may not apply to our montages, however, in order to minimize the chances of having medication affect our results, participants taking the following medications will be excluded:
Show all 15Show fewer
- Na or Ca channel blockers which will include all anti-seizure medications
- Medications that affect the NMDA receptors including dextromethorphan, cycloserine
- Serotonin reuptake inhibitors
- Dopamine stimulating or blocking medications including pergolide, bromocriptine and all antipsychotic medications
- Norepinephrine stimulating or blocking agents including propranolol and the stimulants
- Drugs that can lower seizure threshold [imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, phencyclidine, ketamine, gamma-hydroxybutyrate (GHB), alcohol, theophylline]
- Barbiturates, benzodiazepines, meprobamate, chloral hydrate in the past 4 weeks
- Acute skin disease
- History of magnetic or electrical stimulation
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Pediatrics, Division of Pediatric Neurology, Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
About this study
Official title: A Pilot Study of Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder
Although many children diagnosed with autism spectrum disorder (ASD) make significant progress in learning and their cognitive skills improve with applied behavior analysis (ABA), there are a significant number of children who show an absence or a plateau in various skills. Deficits in executive functioning are likely to be involved in many of these cognitive and learning disabilities due to poor functioning of the prefrontal cortex. Currently, the use of biological methods for improving learning and cognition is largely unexplored in research and practice.
The aim of this study is to use of transcranial direct current stimulation (tDCS) in combination with ABA to improve the acquisition of educational programs for students with ASD. tDCS is a low-level electrical neurostimulation and is most effective when used in combination with an active training or teaching, facilitating the neuronal circuits used for that task.
tDCS has been used for various indications over a couple of decades and has been shown to be very safe and has been well-tolerated by children with ASD. The mechanism of tDCS is not clear, however animal studies show that tDCS can stimulate the flow of calcium ions through channels in the astrocytes, activating them, and facilitating their role in synapse formation and therefore learning.
Read the detailed description
Children with ASD experience a wide range of outcomes, and not all children respond effectively to behavioral interventions. This study uses a novel biologic intervention that combines electrical brain stimulation with ABA treatment to target some of the cognitive deficits in ASD that until now have been relatively refractory to treatment.
There is accumulating evidence of tDCS being effective in treating the comorbidities as well as the core symptoms of ASD. tDCS is most effective when used simultaneously with an active intervention. In this study, the effects of tDCS alone and in combination with ABA on the executive functioning skills and the core symptoms of ASD will be examined and monitored using an objective neurophysiological test (EEG).
This is a double-blind, sham-controlled crossover study involving 20 participants. tDCS will be administered while ABA therapy is being implemented. Programs aimed at language and other cognitive functions will be emphasized. tDCS will be applied bi-frontally with the anode at F3 and the cathode at F4. Forty stimulation sessions will be done (20 active, 20 sham) lasting 20 minutes per session, at 1 milliampere.
- Being tested
- Transcranial Direct Current Stimulation (tDCS), Sham tDCS
- Keywords
- Autism Spectrum Disorder, Transcranial Direct Current Stimulation, Noninvasive Brain Stimulation, Applied Behavior Analysis, Executive Function, Electroencephalogram (EEG)
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
The anodal electrode will be placed over F3 using the international 10-20 EEG electrode placement system to target the left dorsolateral prefrontal cortex (DLPFC).
The cathode electrode will be placed on the right dorsolateral prefrontal cortex.
40 stimulation sessions will be completed (20 active, 20 sham), each lasting 20 minutes per session at 1.0mA.
Sham tDCSDevice
Sham tDCS
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | [Active stimulation first, then crossover to Sham stimulation]
Each participant will receive BOTH sham or active tDCS but the order of each will be randomized. The active tDCS and sham are procedurally identical. Participants in both arms will have the initial tingling sensation and the active tDCS stimulation will CONTINUE for 20 minutes at 1 mA (milliamps). All tDCS sessions will occur during ABA therapy. Receives: Device: Transcranial Direct Current Stimulation (tDCS); Device: Sham tDCS |
| Sham tDCS | Sham comparator | [Sham stimulation first, then crossover to Active stimulation]
Each participant will receive BOTH sham or active tDCS but the order of each will be randomized. The active tDCS and sham are procedurally identical. Participants in both arms will have the initial tingling sensation, except in sham stimulation, the current will be DISCONTINUED after 30 seconds while the power indicator remains on for the remainder of 20 minutes at 0 mA (milliamps). All tDCS sessions will occur during ABA therapy. Receives: Device: Transcranial Direct Current Stimulation (tDCS); Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Behavior Rating Inventory of Executive Function (BRIEF)
The BRIEF is a parent-reported executive function questionnaire which utilizes T-scores, which has a mean of 50 with a standard deviation of 10, with a range of 10-100
Measured: Change measured once per month (at the end of each phase) for 5 months
Change in Electrodncephalogram (EEG)
Power, sample entropy, Lyapunov exponent, detrended fluctuation analysis, correlation dimension, and recurrence quantitative analysis (RQA) values on all frequency bands (delta, theta, alpha, beta, gamma, and gamma+) will be computed from 2-minute resting EEGs using a portable headset
Measured: Change measured once per month (at the end of each phase) for 5 months
Secondary outcomes (2)
Change in the Pervasive Developmental Disorder Behavior Inventory (PDDBI)
The PDDBI is a parent-reported questionnaire about the symptoms of ASD. The PDDBI utilizes T-scores, which has a mean of 50 with a standard deviation of 10, with a range of 10-100. The higher the Approach/Withdrawal Problems and the higher the Autism scores, the more severe the deficits. The higher the Receptive/Expressive Social Communication scores, the better the competence in these areas
Measured: Change measured once per month (at the end of each phase) for 5 months
Change in discrete trial training (DTT) data from applied behavior analysis (ABA) therapy
Individualized behavior data from ABA therapy
Measured: Obtained once at the completion of the study (5 months after the start of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Feb 2022
- Primary completion14 Feb 2024
- Study completion14 Feb 2024
Why it stopped: This was a pilot study and funding ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Model description
- The study will use a randomized double-blind controlled placebo (sham vs. active tDCS) crossover design. The study will involve 5 total months of participation. Participants will be randomized into one of the two groups: Group A) 20 active tDCS stimulation followed by 20 sham stimulation; or Group B) 20 sham stimulation followed by 20 active tDCS stimulation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- New York State Institute for Basic Research, Boston Children's Hospital
- Responsible party
- Principal investigator, Barbie Zimmerman-Bier, M.D., Rutgers, The State University of New Jersey
- Investigators
- Barbie Zimmerman-Bier, M.D., Principal investigator, Department of Pediatrics, Division of Pediatric Neurology Robert Wood Johnson Medical School (RWJMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105126
- Sponsor's protocol ID
- Pro2020000931
- Status last verified
- Apr 2025
- First submitted
- 20 Sep 2021
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Study withdrawn due to loss of funding
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05105126
- Acronym / sponsor ID
- Pro2020000931
- Keywords
- Autism Spectrum Disorder, Transcranial Direct Current Stimulation, Noninvasive Brain Stimulation, Applied Behavior Analysis, Executive Function, Electroencephalogram (EEG)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This was a pilot study and funding ended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- New York State Institute for Basic Research, Boston Children's Hospital
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 3 Nov 2021 (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.
Although many children diagnosed with autism spectrum disorder (ASD) make significant progress in learning and their cognitive skills improve with applied behavior analysis (ABA), there are a significant number of children who show an absence or a plateau in various skills. Deficits in executive functioning are likely to be involved in many of these cognitive and learning disabilities due to poor functioning of the prefrontal cortex. Currently, the use of biological methods for improving learning and cognition is largely unexplored in research and practice.
The aim of this study is to use of transcranial direct current stimulation (tDCS) in combination with ABA to improve the acquisition of educational programs for students with ASD. tDCS is a low-level electrical neurostimulation and is most effective when used in combination with an active training or teaching, facilitating the neuronal circuits used for that task.
tDCS has been used for various indications over a couple of decades and has been shown to be very safe and has been well-tolerated by children with ASD. The mechanism of tDCS is not clear, however animal studies show that tDCS can stimulate the flow of calcium ions through channels in the astrocytes, activating them, and facilitating their role in synapse formation and therefore learning.
Detailed description
Children with ASD experience a wide range of outcomes, and not all children respond effectively to behavioral interventions. This study uses a novel biologic intervention that combines electrical brain stimulation with ABA treatment to target some of the cognitive deficits in ASD that until now have been relatively refractory to treatment.
There is accumulating evidence of tDCS being effective in treating the comorbidities as well as the core symptoms of ASD. tDCS is most effective when used simultaneously with an active intervention. In this study, the effects of tDCS alone and in combination with ABA on the executive functioning skills and the core symptoms of ASD will be examined and monitored using an objective neurophysiological test (EEG).
This is a double-blind, sham-controlled crossover study involving 20 participants. tDCS will be administered while ABA therapy is being implemented. Programs aimed at language and other cognitive functions will be emphasized. tDCS will be applied bi-frontally with the anode at F3 and the cathode at F4. Forty stimulation sessions will be done (20 active, 20 sham) lasting 20 minutes per session, at 1 milliampere.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will use a randomized double-blind controlled placebo (sham vs. active tDCS) crossover design. The study will involve 5 total months of participation. Participants will be randomized into one of the two groups: Group A) 20 active tDCS stimulation followed by 20 sham stimulation; or Group B) 20 sham stimulation followed by 20 active tDCS stimulation
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Transcranial Direct Current Stimulation (tDCS), Device: Sham tDCS[Active stimulation first, then crossover to Sham stimulation] Each participant will receive BOTH sham or active tDCS but the order of each will be randomized. The active tDCS and sham are procedurally identical. Participants in both arms will have the initial tingling sensation and the active tDCS stimulation will CONTINUE for 20 minutes at 1 mA (milliamps). All tDCS sessions will occur during ABA therapy. |
| Sham tDCS | Sham comparator | Device: Transcranial Direct Current Stimulation (tDCS), Device: Sham tDCS[Sham stimulation first, then crossover to Active stimulation] Each participant will receive BOTH sham or active tDCS but the order of each will be randomized. The active tDCS and sham are procedurally identical. Participants in both arms will have the initial tingling sensation, except in sham stimulation, the current will be DISCONTINUED after 30 seconds while the power indicator remains on for the remainder of 20 minutes at 0 mA (milliamps). All tDCS sessions will occur during ABA therapy. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Males and females between 5 and 12 years with autism
- Enrolled in an ABA program (school or in-home) supervised by a Board Certified Behavior Analyst (BCBA)
- Stable medical and behavioral treatments for at least 4 weeks prior to, and during the study
- Able to tolerate wearing tDCS as determined during a week-long daily desensitization training.
Key exclusion criteria (15 listed)
- Any implanted metal device (heart pacemaker, cochlear implant, surgical clips, etc.)
- Severe neurological disorders such as TBI, brain tumor, intracranial infection
- Seizure disorder with a seizure within the last two years
- Skull defect
- Peripheral blindness or deafness
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 |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)The anodal electrode will be placed over F3 using the international 10-20 EEG electrode placement system to target the left dorsolateral prefrontal cortex (DLPFC). The cathode electrode will be placed on the right dorsolateral prefrontal cortex. 40 stimulation sessions will be completed (20 active, 20 sham), each lasting 20 minutes per session at 1.0mA. | Device | Active tDCS, Sham tDCS |
| Sham tDCSSham tDCS | Device | Active tDCS, Sham tDCS |
Primary outcome
Change in the Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: Change measured once per month (at the end of each phase) for 5 months
The BRIEF is a parent-reported executive function questionnaire which utilizes T-scores, which has a mean of 50 with a standard deviation of 10, with a range of 10-100
Change in Electrodncephalogram (EEG)
Time frame: Change measured once per month (at the end of each phase) for 5 months
Power, sample entropy, Lyapunov exponent, detrended fluctuation analysis, correlation dimension, and recurrence quantitative analysis (RQA) values on all frequency bands (delta, theta, alpha, beta, gamma, and gamma+) will be computed from 2-minute resting EEGs using a portable headset
2 secondary outcomes
Change in the Pervasive Developmental Disorder Behavior Inventory (PDDBI)
Time frame: Change measured once per month (at the end of each phase) for 5 months
Change in discrete trial training (DTT) data from applied behavior analysis (ABA) therapy
Time frame: Obtained once at the completion of the study (5 months after the start of the study)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No. Study withdrawn due to loss of funding
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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.
Barbie Zimmerman-Bier, M.D. principal investigator
Department of Pediatrics, Division of Pediatric Neurology Robert Wood Johnson Medical School (RWJMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Autism Spectrum Disorder and Executive Dysfunction, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 4 inclusion and 15 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: withdrawn, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in the Behavior Rating Inventory of Executive Function (BRIEF) (time frame: Change measured once per month (at the end of each phase) for 5 months). The study lists 2 primary outcomes in all. 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 24 Apr 2025.