Autism Spectrum DisorderNCT04446442
Cerebellar tDCS in Children With Autism Spectrum Disorder
A study testing tDCS in people with Autism Spectrum Disorder, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial summary
The purpose of this research study is to investigate whether tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults with autism spectrum disorders (ASD) is safe and to examine its effects on some of the symptoms of ASD, such as repetitive behaviors and… Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Jun 2019to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 4-17 years old
- Diagnosed with ASD and ADOS-2
- IQ Score no less than 70 (1.5 Standard Deviations below the mean)
- Language Level (Speech consists of, at minimum, flexible, spontaneous, simple, sentences)
Who cannot join
- Brain implants, metal implants, pacemakers, or biomedical devices
- Diagnosis of epilepsy
- Hearing or visual impairments
- History of brain injury
- Known brain abnormalities not associated with ASD
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Children's Medical Center
Dallas, Texas, 75235
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
About this study
Official title: Biologic Effects and Efficacy of Cerebellar tDCS in Children With Autism Spectrum Disorder
The purpose of this research study is to investigate whether tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults with autism spectrum disorders (ASD) is safe and to examine its effects on some of the symptoms of ASD, such as repetitive behaviors and hyperactivity.
Read the detailed description
The study will be randomized, double-blind, and controlled. It will involve a group of 60 children with ASD (diagnosed with the Autism Diagnostic Observation Schedule (ADOS-2) by a research-reliable clinician) coming in for an orientation day, where participants will be acclimated to the testing environment, as well as undergo safety screening, and a mock MRI. The investigators will recruit from a sample of children diagnosed with ASD (The diagnosis must be made by experienced, research reliable clinicians using gold standard measures including the Autism Diagnostic Observation schedule Second Edition Study, or ADOS-2 and a diagnostic and developmental parent interview). The investigators will request this information from the institution where the diagnosis was given with parent/caregiver permission. Diagnostic information will be reviewed by the study neuropsychologist, and if additional testing is needed to update or confirm the diagnosis, the investigators will administer an ADOS-2 here at UTSW prior to other baseline measures. If diagnostic information from a previous CADD clinic visit or an outside institution by a research reliable clinician is current, the investigators will accept it.
Participants will complete in a variety of tasks during a pre-treatment visit. In addition, baseline behavioral measurements will be performed. These tests include an abbreviated measure of cognitive ability using the Stanford Binet-Fifth Edition, interpretation of facial expressions, memory for faces, reading the mind in the eyes, triangle animations, cyberball /social ball throwing, dimensional card change sort, and caregiver-completed behavioral scale including the Autsim Spectrum Rating Scale (ASRS). Participants will also be asked about their mood before, during, and after treatment. Participants will then be randomly assigned into either a sham treatment group or an active treatment group. The next time the participants come in, participants vitals will be monitored in addition to eye monitoring and will undergo either 1 mA for 20 minutes of anodal or cathodal tDCS administration to Right Crus I/II area of the cerebellum or sham treatment. Participants will undergo fMRI imaging prior, during, and after anodal or cathodal tDCS. After the scans, testing will be repeated and include interpretation of facial expression, memory for faces, reading the mind in the eyes, triangle animations, theory of mind, cyberball/social ball throwing, and dimensional card change sort. At the end of the visit parents/guardians/participants will receive a safety questionnaire asking about the presence and severity of the possible side effects. The participants will then follow up in 1 week with the safety questionnaire and at 1 month with the safety questionnaire and the Autism Spectrum Rating Scale.
Study Procedures:
Investigators, including those involved in questionnaire and behavioral scales administration and fMRI scanning/interpreting will be blinded to which treatment group participants are in. Staff members in charge of applying tDCS will be aware of what treatment group the participant is in but will not be involved in analysis of data to ensure blinding of results. As far as the tDCS procedure goes, the device consists of a programmable current source with a rechargeable battery with two wires connected to electrodes in fabric pads. The device cannot be plugged into an outlet while the electrodes are connected, ensuring safety. tDCS pads are moistened with 0.9% normal saline and placed on the participant's scalp using elastic bands. During stimulation, the electrodes will apply 1 mA of constant DC electrical current. Current will be increased over 10-60 seconds. The current will be applied for no more than 20 minutes, after which the current is decreased over 10-60 seconds. In sham tDCS, the current is increased and then immediately decreased to provide sensations associated with tDCS (mild tingling or itching, which blinds the participant).
Testing will take place before (on orientation day) and after tDCS. Baseline testing includes an ADOS-2 if deemed necessary, an abbreviated cognitive measure, interpretation of facial expressions, memory for faces, reading the mind in the eyes, triangle animations, cyberball /social ball throwing, dimensional card change sort, and caregiver-completed behavioral scale including the Autsim Spectrum Rating Scale.. Testing immediately after tDCS includes only the following: interpretation of facial expressions, memory for faces, reading the mind in the eyes, triangle animations, theory of mind, cyberball/social ball throwing, and dimensional card change sort.
Participants with ASD will come in on designated orientation days and be assigned an alphanumeric identifier to ensure confidentiality. An initial safety screening will be done to ensure no exclusion criteria are met. Participants will then be randomly split into either a sham group or a treatment group. Baseline testing will be completed. Participants will then be allowed to explore and become acclimated with study equipment, and a mock MRI will be done on the first visit at the UTSW Advanced Imaging Research Center (AIRC).
Participants will be desensitized to the sounds and tactile sensations of the fMRI environment while in a space similar to that of the scanner bore. Participants will practice remaining still within the mock MRI while viewing a movie, and biofeedback is used to train participants to keep their movement <1mm during practice periods of 10 minutes. Participants should be able to complete all of the screening in one visit. If participants cannot due to time constraints participants will be brought back in on a different day to complete the screening visit.
The next time participants return, participants will be hooked up to vitals and eye movement monitoring and will be placed in the fMRI machine so the "before" scanning can begin. After this "before" scan, tDCS electrodes will be applied and participants will again be placed in the fMRI machine for the "during" scan. As soon as scanning begins, tDCS (either sham or treatment of 1 mA for 20 minutes of anodal tDCS administration to the Right Crus I/II area of the cerebellum) will begin as well. During tDCS treatment caregivers will receive a safety questionnaire for them to assess any side effects occurring in their child. After this scan, the tDCS electrode will be removed, and a final "after" fMRI scan will take place. The safety questionnaire will be given after tDCS at the end of the visit and behavioral tests are complete.The time estimated for all of this is about 90-180 minutes.
The Safety Questionnaire will be assessed again with follow-up visits 1 week and 1 month afterwards using the same caregiver-completed scales.
- Conditions
- Autism Spectrum Disorder
- Being tested
- tDCS
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
A current of 1 mA will be administered for 20 minutes of with either anodal or cathodal tDCS administration to the right crus I/II area of the cerebellum.
| Study group | Role | What they receive |
|---|---|---|
| Full Administration of Transcranial Direct Current Stimulation | Experimental | Each subject will undergo psychosocial and behavioral assessments at a session prior to the administration of tDCS. The second session will include the tDCS Administration; a current of 1 mA will be administered over 20 minutes to the right crusI/II area of the cerebellum with a 15 second fade in period at the beginning and a 15 second fade out period at the end. During the tDCS administration, subjects will undergo functional MRI scanning. After the tDCS administration, subjects will repeat psychosocial and behavioral assessments. Receives: Device: tDCS |
| Sham Administration of Transcranial Direct Current Stimulation | Sham comparator | Each subject will undergo psychosocial and behavioral assessments at a session prior to the administration of tDCS. The second session will include the tDCS Administration; a current of 1mA increased over 15 seconds and immediately decreased over 15 seconds to provide sensation associated with tDCS. During the sham administration, subjects will undergo functional MRI scanning. After the tDCS administration, subjects will repeat psychosocial and behavioral assessments. Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of tDCS associated side effects assessed by tDCS Safety Assessment
Observe whether tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) is safe and easily tolerated using a tDCS Safety Assessment
Measured: Post-Intervention up to one month
Secondary outcomes (6)
Change in Autism Spectrum Disorder Symptoms assessed by NEPSY-2 Subtests
Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, related to social behavior and cognition. The NEPSY-2 subtests include: Memory for Faces, Theory of Mind, and Affect Recognition. The NEPSY-2 subtests are designed to assess abilities related to memory, learning, and social perception.
Measured: Pre-Intervention at 1 week and Post-Intervention at 1 hour
Change in Autism Spectrum Disorder Symptoms assessed by Reading the Mind in the Eyes
Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, related to social behavior and cognition. This will be assessed by Reading the Mind in the Eyes, a measure of complex mental state recognition.
Measured: Pre-Intervention at 1 week and Post-Intervention at 1 hour
Change in Autism Spectrum Disorder Symptoms assessed by Triangle Animations/Social Perception Task
Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, related to social behavior and cognition. The Triangle Animations/ Social Perception Task assesses Theory of Mind mental functions such as belief and intention.
Measured: Pre-Intervention at 1 week and Post-Intervention at 1 hour
Change in Autism Spectrum Disorder Symptoms assessed by Cyberball/Social Ball Throwing Task
Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, related to social behavior. The Cyberball/Social Ball Throwing Task assesses engagement in social interaction.
Measured: Pre-Intervention at 1 week and Post-Intervention at 1 hour
Change in Autism Spectrum Disorder Symptoms assessed by Dimensional Change Card Sort
Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, related to cognition. The Dimensional Change Card Sort is a measure of cognitive flexibility, also known as task switching or set shifting.
Measured: Pre-Intervention at 1 week and Post-Intervention at 1 hour
Change in Autism Spectrum Disorder Symptoms assessed by Autism Spectrum Rating Scale
Observe tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) and its effects on some of the symptoms of ASD, such as repetitive behaviors and hyperactivity. The Autism Spectrum Rating Scale (ASRS) is a nationally-standardized, norm-referenced checklist designed to identify symptoms, behaviors, and associated features of Autism Spectrum Disorders in children and adolescents. Using a five-point Likert rating scale (1- Never, 2- Rarely, 3- Occasionally, 4- Frequently, 5- Very Frequently), parents/caregivers are asked to evaluate how often they observed specific behaviors in the child or adolescent in areas such as socialization, communication, unusual behaviors, behavioral rigidity, sensory sensitivity, and self-regulation.
Measured: Pre-Intervention at 1 week and Post-Intervention at 1 week and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start4 Jun 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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 University of Texas Southwestern Medical CenterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Peter Tsai, University of Texas Southwestern Medical Center
- Investigators
- Peter Tsai, MD, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446442
- Sponsor's protocol ID
- UTSW 022017-071
- Other IDs
- W81XWH1910249
- Status last verified
- Jun 2026
- First submitted
- 12 Nov 2019
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologic Effects and Efficacy of Cerebellar tDCS in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04446442
- Acronym / sponsor ID
- UTSW 022017-071
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Jun 2020 (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.
The purpose of this research study is to investigate whether tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults with autism spectrum disorders (ASD) is safe and to examine its effects on some of the symptoms of ASD, such as repetitive behaviors and hyperactivity.
Detailed description
The study will be randomized, double-blind, and controlled. It will involve a group of 60 children with ASD (diagnosed with the Autism Diagnostic Observation Schedule (ADOS-2) by a research-reliable clinician) coming in for an orientation day, where participants will be acclimated to the testing environment, as well as undergo safety screening, and a mock MRI. The investigators will recruit from a sample of children diagnosed with ASD (The diagnosis must be made by experienced, research reliable clinicians using gold standard measures including the Autism Diagnostic Observation schedule Second Edition Study, or ADOS-2 and a diagnostic and developmental parent interview). The investigators will request this information from the institution where the diagnosis was given with parent/caregiver permission. Diagnostic information will be reviewed by the study neuropsychologist, and if additional testing is needed to update or confirm the diagnosis, the investigators will administer an ADOS-2 here at UTSW prior to other baseline measures. If diagnostic information from a previous CADD clinic visit or an outside institution by a research reliable clinician is current, the investigators will accept it.
Participants will complete in a variety of tasks during a pre-treatment visit. In addition, baseline behavioral measurements will be performed. These tests include an abbreviated measure of cognitive ability using the Stanford Binet-Fifth Edition, interpretation of facial expressions, memory for faces, reading the mind in the eyes, triangle animations, cyberball /social ball throwing, dimensional card change sort, and caregiver-completed behavioral scale including the Autsim Spectrum Rating Scale (ASRS). Participants will also be asked about their mood before, during, and after treatment. Participants will then be randomly assigned into either a sham treatment group or an active treatment group. The next time the participants come in, participants vitals will be monitored in addition to eye monitoring and will undergo either 1 mA for 20 minutes of anodal or cathodal tDCS administration to Right Crus I/II area of the cerebellum or sham treatment. Participants will undergo fMRI imaging prior, during, and after anodal or cathodal tDCS. After the scans, testing will be repeated and include interpretation of facial expression, memory for faces, reading the mind in the eyes, triangle animations, theory of mind, cyberball/social ball throwing, and dimensional card change sort. At the end of the visit parents/guardians/participants will receive a safety questionnaire asking about the presence and severity of the possible side effects. The participants will then follow up in 1 week with the safety questionnaire and at 1 month with the safety questionnaire and the Autism Spectrum Rating Scale.
Study Procedures:
Investigators, including those involved in questionnaire and behavioral scales administration and fMRI scanning/interpreting will be blinded to which treatment group participants are in. Staff members in charge of applying tDCS will be aware of what treatment group the participant is in but will not be involved in analysis of data to ensure blinding of results. As far as the tDCS procedure goes, the device consists of a programmable current source with a rechargeable battery with two wires connected to electrodes in fabric pads. The device cannot be plugged into an outlet while the electrodes are connected, ensuring safety. tDCS pads are moistened with 0.9% normal saline and placed on the participant's scalp using elastic bands. During stimulation, the electrodes will apply 1 mA of constant DC electrical current. Current will be increased over 10-60 seconds. The current will be applied for no more than 20 minutes, after which the current is decreased over 10-60 seconds. In sham tDCS, the current is increased and then immediately decreased to provide sensations associated with tDCS (mild tingling or itching, which blinds the participant).
Testing will take place before (on orientation day) and after tDCS. Baseline testing includes an ADOS-2 if deemed necessary, an abbreviated cognitive measure, interpretation of facial expressions, memory for faces, reading the mind in the eyes, triangle animations, cyberball /social ball throwing, dimensional card change sort, and caregiver-completed behavioral scale including the Autsim Spectrum Rating Scale.. Testing immediately after tDCS includes only the following: interpretation of facial expressions, memory for faces, reading the mind in the eyes, triangle animations, theory of mind, cyberball/social ball throwing, and dimensional card change sort.
Participants with ASD will come in on designated orientation days and be assigned an alphanumeric identifier to ensure confidentiality. An initial safety screening will be done to ensure no exclusion criteria are met. Participants will then be randomly split into either a sham group or a treatment group. Baseline testing will be completed. Participants will then be allowed to explore and become acclimated with study equipment, and a mock MRI will be done on the first visit at the UTSW Advanced Imaging Research Center (AIRC).
Participants will be desensitized to the sounds and tactile sensations of the fMRI environment while in a space similar to that of the scanner bore. Participants will practice remaining still within the mock MRI while viewing a movie, and biofeedback is used to train participants to keep their movement <1mm during practice periods of 10 minutes. Participants should be able to complete all of the screening in one visit. If participants cannot due to time constraints participants will be brought back in on a different day to complete the screening visit.
The next time participants return, participants will be hooked up to vitals and eye movement monitoring and will be placed in the fMRI machine so the "before" scanning can begin. After this "before" scan, tDCS electrodes will be applied and participants will again be placed in the fMRI machine for the "during" scan. As soon as scanning begins, tDCS (either sham or treatment of 1 mA for 20 minutes of anodal tDCS administration to the Right Crus I/II area of the cerebellum) will begin as well. During tDCS treatment caregivers will receive a safety questionnaire for them to assess any side effects occurring in their child. After this scan, the tDCS electrode will be removed, and a final "after" fMRI scan will take place. The safety questionnaire will be given after tDCS at the end of the visit and behavioral tests are complete.The time estimated for all of this is about 90-180 minutes.
The Safety Questionnaire will be assessed again with follow-up visits 1 week and 1 month afterwards using the same caregiver-completed scales.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full Administration of Transcranial Direct Current Stimulation | Experimental | Device: tDCSEach subject will undergo psychosocial and behavioral assessments at a session prior to the administration of tDCS. The second session will include the tDCS Administration; a current of 1 mA will be administered over 20 minutes to the right crusI/II area of the cerebellum with a 15 second fade in period at the beginning and a 15 second fade out period at the end. During the tDCS administration, subjects will undergo functional MRI scanning. After the tDCS administration, subjects will repeat psychosocial and behavioral assessments. |
| Sham Administration of Transcranial Direct Current Stimulation | Sham comparator | Device: tDCSEach subject will undergo psychosocial and behavioral assessments at a session prior to the administration of tDCS. The second session will include the tDCS Administration; a current of 1mA increased over 15 seconds and immediately decreased over 15 seconds to provide sensation associated with tDCS. During the sham administration, subjects will undergo functional MRI scanning. After the tDCS administration, subjects will repeat psychosocial and behavioral assessments. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 4-17 years old
- Diagnosed with ASD and ADOS-2
- IQ Score no less than 70 (1.5 Standard Deviations below the mean)
- Language Level (Speech consists of, at minimum, flexible, spontaneous, simple, sentences)
Key exclusion criteria (5 listed)
- Brain implants, metal implants, pacemakers, or biomedical devices
- Diagnosis of epilepsy
- Hearing or visual impairments
- History of brain injury
- Known brain abnormalities not associated with ASD
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 |
|---|---|---|
| tDCSA current of 1 mA will be administered for 20 minutes of with either anodal or cathodal tDCS administration to the right crus I/II area of the cerebellum. | Device | Full Administration of Transcranial Direct Current Stimulation, Sham Administration of Transcranial Direct Current Stimulation |
Primary outcome
Incidence of tDCS associated side effects assessed by tDCS Safety Assessment
Time frame: Post-Intervention up to one month
Observe whether tDCS to the cerebellum (specifically, the right crus I/II area of the cerebellum) of children and young adults diagnosed with autism spectrum disorders (ASD) is safe and easily tolerated using a tDCS Safety Assessment
6 secondary outcomes
Change in Autism Spectrum Disorder Symptoms assessed by NEPSY-2 Subtests
Time frame: Pre-Intervention at 1 week and Post-Intervention at 1 hour
Change in Autism Spectrum Disorder Symptoms assessed by Reading the Mind in the Eyes
Time frame: Pre-Intervention at 1 week and Post-Intervention at 1 hour
Change in Autism Spectrum Disorder Symptoms assessed by Triangle Animations/Social Perception Task
Time frame: Pre-Intervention at 1 week and Post-Intervention at 1 hour
Change in Autism Spectrum Disorder Symptoms assessed by Cyberball/Social Ball Throwing Task
Time frame: Pre-Intervention at 1 week and Post-Intervention at 1 hour
Change in Autism Spectrum Disorder Symptoms assessed by Dimensional Change Card Sort
Time frame: Pre-Intervention at 1 week and Post-Intervention at 1 hour
Change in Autism Spectrum Disorder Symptoms assessed by Autism Spectrum Rating Scale
Time frame: Pre-Intervention at 1 week and Post-Intervention at 1 week and 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Peter Tsai, MD, PhD principal investigator
University of Texas Southwestern Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Autism Spectrum Disorder, run by University of Texas Southwestern Medical Center at 2 sites 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 5 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: looking for participants now, as of the sponsor's last update on 4 Jun 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Tsai, MD, PhD (214-648-3577, peter.tsai@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of tDCS associated side effects assessed by tDCS Safety Assessment (time frame: Post-Intervention up to one month). 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 4 Jun 2026.