Autism Spectrum DisorderNCT05691283
Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder: Raynor Cerebellum Project
A study testing trans cranial direct current stimulation (tDCS) in people with Autism Spectrum Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to investigate the effects of transcranial direct current stimulation (tDCS) on some of the challenges faced by children with Autism Spectrum Disorder (ASD). Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- trans cranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2023to 30 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 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 5 to 21, male and female, with known autism spectrum disorder as diagnosed by a clinician
Who cannot join
- Pregnancy
- Brain implants
- Pacemakers
- Any biomedical or metal implants in any part of body
- Hearing or visual impairment
- History of brain injury
- Known brain or skull abnormality other than those that may be associated with ASD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dalls, Texas, 75390-8568
Haley Walker, Haley.walker@utsouthwestern.edu
About this study
Official title: Right Lateralized Posterior Cerebellar tDCS in Children With Autism Spectrum Disorder
The purpose of this research study is to investigate the effects of transcranial direct current stimulation (tDCS) on some of the challenges faced by children with Autism Spectrum Disorder (ASD).
Read the detailed description
The study will be randomized, double-blind, within subject crossover design. It will involve a group of 30-40 children and young adults with Autism Spectrum Disorder (ASD). We may recruit up to 60 subjects. Diagnosis of ASD will be confirmed with the Autism Diagnostic Interview-Revised (ADI-R) or Autism Diagnostic Observation Schedule-2 (ADOS-2) by a research-reliable clinician. Each participant will undergo a sham condition and a transcranial direct current stimulation (tDCS) condition, the order of sham and tDCS conditions will be randomly assigned to each participant during baseline testing. Sham refers to participants only receiving 1 milliamp of tDCS stimulation for 1 minute, and tDCS stimulation refers to 20 minutes of tDCS stimulation. The study involves an initial screening visit followed by two sessions with three months between each session period. Each session includes the following: pre-testing and imaging, tDCS 3-week session, post-testing and imaging. Participants will complete an initial screening to confirm clinical diagnosis of ASD, determine baseline cognitive functioning, and complete a practice Magnetic Resonance Imaging (MRI) and Magnetoencephalography (MEG) session. At pre-testing, they will complete a psychometric battery, as well as undergo safety screening, and an MRI and/or MEG. Each 3-week tDCS sessions will be randomized, and each participant will undergo three weeks of sham stimulation and three weeks of 20-minute tDCS stimulation. Neither the researchers nor the participants will know which group they are assigned during each three-week session.
- Conditions
- Autism Spectrum Disorder
- Being tested
- trans cranial direct current stimulation (tDCS), Sham
- Keywords
- Children, Young adults, Autism Spectrum Disorder, Transcranial direct current stimulation, 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.
trans cranial direct current stimulation (tDCS)Device
Three weeks of 20-minute tDCS stimulation
ShamDevice
Three weeks of sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| transcranial direct current stimulation (tDCS), then sham stimulation | Experimental | Participants receives three weeks of 20-minute tDCS stimulation. After a washout period of 3 months, they then receive three weeks of sham stimulation Receives: Device: trans cranial direct current stimulation (tDCS); Device: Sham |
| Sham stimulation, then transcranial direct current stimulation (tDCS) | Experimental | Participants receives three weeks of sham stimulation. After a washout period of 3 months, they then receive three weeks of 20-minute tDCS stimulation Receives: Device: trans cranial direct current stimulation (tDCS); Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social behavior as measured by Reading the Mind in the Eyes (RME) Child Version
Reading the Mind in the Eyes (RME) Child Version will be used to measure complex mental state recognition. This test consists of 28 photographs of the eye region of the human face, each surrounded by four words. Participants pick the word that best describes what the person in the photo is thinking or feeling. Scores range from 0-28, higher score indicates very accurate at decoding a person's facial expressions around their eyes.
Measured: Baseline
Social behavior as measured by Reading the Mind in the Eyes (RME) Child Version
Reading the Mind in the Eyes (RME) Child Version will be used to measure complex mental state recognition. This test consists of 28 photographs of the eye region of the human face, each surrounded by four words. Participants pick the word that best describes what the person in the photo is thinking or feeling. Scores range from 0-28, higher score indicates very accurate at decoding a person's facial expressions around their eyes.
Measured: Post Treatment (approx at 3 month)
Social behavior as measured by Cyberball/Social Ball Throwing Task
Cyberball/Social Ball Throwing Task will be used to measure social interaction. In this task, the participant engaged in a virtual ball throwing game with two other players. There are three conditions the participants will be randomly assigned to. In two conditions participants are thrown the ball an equal number of times, in the other condition the participant is only thrown the ball a few times. After the participant completes the task, they are given a rating scale to rate how well they trust and prefer the other two players on a scale from 1-7 (totally mistrust to totally trust). The ratings indicated how well the subject was able to determine if they were left out of the group"
Measured: Baseline
Social behavior as measured by Cyberball/Social Ball Throwing Task
Cyberball/Social Ball Throwing Task will be used to measure social interaction. In this task, the participant engaged in a virtual ball throwing game with two other players. There are three conditions the participants will be randomly assigned to. In two conditions participants are thrown the ball an equal number of times, in the other condition the participant is only thrown the ball a few times. After the participant completes the task, they are given a rating scale to rate how well they trust and prefer the other two players on a scale from 1-7 (totally mistrust to totally trust). The ratings indicated how well the subject was able to determine if they were left out of the group"
Measured: Post Treatment (approx at 3 month)
Sensorimotor behavior as measured by Grip Strength
Participants grip a specially designed fiber optic device (Aither Engineering, Inc.). This device detects nanometer changes in grip force which are calibrated in Newtons. Participants are instructed to rest their arm in a relaxed position. Subjects use their thumb and index finger to press against grip device. Prior to testing, each subject will complete the maximum voluntary contraction for each hand during trials of 3 seconds each with 15 seconds in between each trial. The subject is then instructed to press as hard as they can when the screen says "go" using only the thumb and pointer finger.
Measured: Baseline
Sensorimotor behavior as measured by Grip Strength
Participants grip a specially designed fiber optic device (Aither Engineering, Inc.). This device detects nanometer changes in grip force which are calibrated in Newtons. Participants are instructed to rest their arm in a relaxed position. Subjects use their thumb and index finger to press against grip device. Prior to testing, each subject will complete the maximum voluntary contraction for each hand during trials of 3 seconds each with 15 seconds in between each trial. The subject is then instructed to press as hard as they can when the screen says "go" using only the thumb and pointer finger.
Measured: Post Treatment (approx at 3 month)
Sensorimotor behavior as measured by Reach Task
Participants will be positioned at a table with reaching arm resting on the table in a neutral position. The task includes picking up small objects placed on the table and placing the objects one by one into a target container in two trials: preferred and non-preferred hands. The task is rated on a 6-point rating scale, where 5 represents weakest performance, and 0 represents best performance. Each item is given a raw score and a standard score, which translate to a component score and percentile rank.
Measured: Baseline
Sensorimotor behavior as measured by Reach Task
Participants will be positioned at a table with reaching arm resting on the table in a neutral position. The task includes picking up small objects placed on the table and placing the objects one by one into a target container in two trials: preferred and non-preferred hands. The task is rated on a 6-point rating scale, where 5 represents weakest performance, and 0 represents best performance. Each item is given a raw score and a standard score, which translate to a component score and percentile rank.
Measured: Post Treatment (approx at 3 month)
Sensorimotor behavior as measured by Sensory Profile-2
A parent self-report form designed to assess sensory processing patterns in children and adolescents. The report includes three subscales: sensory system, behavior, and sensory pattern.Each item is scored on a Likert scale from 1 to 5 (1=Much Less Than Others, 2=Less Than Others, 3=Just Like the Majority of Others, 4=More Than Others, 5=Much More Than Others). Raw scores are totaled and converted to percentile ranks based on participant age.
Measured: Baseline
Sensorimotor behavior as measured by Sensory Profile-2
A parent self-report form designed to assess sensory processing patterns in children and adolescents. The report includes three subscales: sensory system, behavior, and sensory pattern.Each item is scored on a Likert scale from 1 to 5 (1=Much Less Than Others, 2=Less Than Others, 3=Just Like the Majority of Others, 4=More Than Others, 5=Much More Than Others). Raw scores are totaled and converted to percentile ranks based on participant age.
Measured: Post Treatment (approx at 3 month)
Neurophysiological impacts as measured by Magnetoencephalography (MEG)
MEG data will be processed using AFNI (https://afni.nimh.nih.gov/). Using all channels of the MEG data, strength and latency of responses are measured by transforming each subject's raw MEG activity into brain space. A spatial filter is applied which separates the source activity from different brain regions to observe overlap at the sensor level. This analysis will assess functional connectivity between the region of interest (ROI) voxel, the right Crus I of the cerebellum, compared to all other voxels in the brain. Seed-based voxel correlation analysis enables researchers to see the statistical correlation between the ROI activity and activity in other cortical areas. This correlation reveals patterns of connectivity between the ROI and other cortical regions. The second level analysis will utilize a one-way ANOVAs will compare baseline measures (Cyberball, Precision Grip) and demographics (e.g. age) within groups. The within subjects' effect of tDCS on task scores will be evaluated
Measured: Baseline
Neurophysiological impacts as measured by Magnetoencephalography (MEG)
MEG data will be processed using AFNI (https://afni.nimh.nih.gov/). Using all channels of the MEG data, strength and latency of responses are measured by transforming each subject's raw MEG activity into brain space. A spatial filter is applied which separates the source activity from different brain regions to observe overlap at the sensor level. This analysis will assess functional connectivity between the region of interest (ROI) voxel, the right Crus I of the cerebellum, compared to all other voxels in the brain. Seed-based voxel correlation analysis enables researchers to see the statistical correlation between the ROI activity and activity in other cortical areas. This correlation reveals patterns of connectivity between the ROI and other cortical regions. The second level analysis will utilize a one-way ANOVAs will compare baseline measures (Cyberball, Precision Grip) and demographics (e.g. age) within groups. The within subjects' effect of tDCS on task scores will be evaluated
Measured: Post Treatment (approx at 3 month)
Neurophysiological impacts as measured by functional magnetic resonance imaging (fMRI)
fMRI data will be processed using AFNI (https://afni.nimh.nih.gov/). A regression analyses is used (3dDeconvolve and 3dREML) for each subject. Data collected from MRI acquisition will be analyzed at two levels. The first level of analysis will use seed-based voxel correlational analysis, a statistical technique for observing differences in brain activity. This analysis will assess functional connectivity between the region of interest (ROI) voxel, the right Crus I of the cerebellum, compared to all other voxels in the brain. Seed-based voxel correlation analysis enables researchers to see the statistical correlation between the ROI activity and activity in other cortical areas. This correlation reveals patterns of connectivity between the ROI and other cortical regions. The second level analysis will utilize a one-way ANOVAs will compare baseline measures (Cyberball, Precision Grip) and demographics (e.g. age) within groups.
Measured: Baseline
Neurophysiological impacts as measured by functional magnetic resonance imaging (fMRI)
fMRI data will be processed using AFNI (https://afni.nimh.nih.gov/). A regression analyses is used (3dDeconvolve and 3dREML) for each subject. Data collected from MRI acquisition will be analyzed at two levels. The first level of analysis will use seed-based voxel correlational analysis, a statistical technique for observing differences in brain activity. This analysis will assess functional connectivity between the region of interest (ROI) voxel, the right Crus I of the cerebellum, compared to all other voxels in the brain. Seed-based voxel correlation analysis enables researchers to see the statistical correlation between the ROI activity and activity in other cortical areas. This correlation reveals patterns of connectivity between the ROI and other cortical regions. The second level analysis will utilize a one-way ANOVAs will compare baseline measures (Cyberball, Precision Grip) and demographics (e.g. age) within groups.
Measured: Post Treatment (approx at 3 month)
Secondary outcomes (6)
Executive functioning as measured by Flanker Inhibitory Control and Attention
The NIH Toolbox Flanker Inhibitory Control and Attention Test measures both a participant's attention and inhibitory control. Accuracy and reaction scores range in value between 0 and 5. If accuracy scores for the participant reach more than 80%, the reaction time score and accuracy score are combined. Combined scores range in value from 0-10. This score shows how accurate and how quickly the subject responded, the high the score the more accurate and quickly each subject responded.
Measured: Baseline
Executive functioning as measured by Flanker Inhibitory Control and Attention
The NIH Toolbox Flanker Inhibitory Control and Attention Test measures both a participant's attention and inhibitory control. Accuracy and reaction scores range in value between 0 and 5. If accuracy scores for the participant reach more than 80%, the reaction time score and accuracy score are combined. Combined scores range in value from 0-10. This score shows how accurate and how quickly the subject responded, the high the score the more accurate and quickly each subject responded.
Measured: Post Treatment (approx at 3 month)
Executive functioning as measured by Dimensional Card Change Sort
The Dimensional Change Card Sort (DCCS) is a measure of cognitive flexibility, also known as task switching or set shifting. Scoring is based on a combination of accuracy and reaction time. Accuracy and reaction scores range in value between 0 and 5. If accuracy scores for the participant reach more than 80%, the reaction time score and accuracy score are combined. Combined scores range in value from 0-10. This score shows how accurate and how quickly the subject responded, the high the score the more accurate and quickly each subject responded.
Measured: Baseline
Executive functioning as measured by Dimensional Card Change Sort
The Dimensional Change Card Sort (DCCS) is a measure of cognitive flexibility, also known as task switching or set shifting. Scoring is based on a combination of accuracy and reaction time. Accuracy and reaction scores range in value between 0 and 5. If accuracy scores for the participant reach more than 80%, the reaction time score and accuracy score are combined. Combined scores range in value from 0-10. This score shows how accurate and how quickly the subject responded, the high the score the more accurate and quickly each subject responded.
Measured: Post Treatment (approx at 3 month)
Working memory as measured by Stanford Binet-V Working Memory Subtest
Stanford Binet-V Working Memory Subtest assesses how well the subject recalls facts and objects. This area assesses how well the subject recalls facts and objects. At lower levels, the non-verbal test involves asking the subject to find an object hidden under a cup, or block tapping in which the subject must repeat a sequence of tapping on blocks initiated by the examiner. The verbal test requires the subject to recall the last words of several sentences in a series. Raw scores are the total number of items correct and are converted into standard scores (0-119) for each subtest based on participant age. Standard scores of 100-110 are considered average for the subjects age range
Measured: Baseline
Working memory as measured by Stanford Binet-V Working Memory Subtest
Stanford Binet-V Working Memory Subtest assesses how well the subject recalls facts and objects. This area assesses how well the subject recalls facts and objects. At lower levels, the non-verbal test involves asking the subject to find an object hidden under a cup, or block tapping in which the subject must repeat a sequence of tapping on blocks initiated by the examiner. The verbal test requires the subject to recall the last words of several sentences in a series. Raw scores are the total number of items correct and are converted into standard scores (0-119) for each subtest based on participant age. Standard scores of 100-110 are considered average for the subjects age range
Measured: Post Treatment (approx at 3 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start20 Jun 2023
- Primary completion30 Dec 2027 (estimated)
- Study completion30 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- 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
- NCT05691283
- Sponsor's protocol ID
- STU-2022-0689
- Status last verified
- Oct 2026
- First submitted
- 21 Dec 2022
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Lateralized Posterior Cerebellar tDCS in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05691283
- Acronym / sponsor ID
- STU-2022-0689
- Conditions
- Autism Spectrum Disorder
- Keywords
- Children, Young adults, Autism Spectrum Disorder, Transcranial direct current stimulation, tDCS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 20 Jan 2023 (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 the effects of transcranial direct current stimulation (tDCS) on some of the challenges faced by children with Autism Spectrum Disorder (ASD).
Detailed description
The study will be randomized, double-blind, within subject crossover design. It will involve a group of 30-40 children and young adults with Autism Spectrum Disorder (ASD). We may recruit up to 60 subjects. Diagnosis of ASD will be confirmed with the Autism Diagnostic Interview-Revised (ADI-R) or Autism Diagnostic Observation Schedule-2 (ADOS-2) by a research-reliable clinician. Each participant will undergo a sham condition and a transcranial direct current stimulation (tDCS) condition, the order of sham and tDCS conditions will be randomly assigned to each participant during baseline testing. Sham refers to participants only receiving 1 milliamp of tDCS stimulation for 1 minute, and tDCS stimulation refers to 20 minutes of tDCS stimulation. The study involves an initial screening visit followed by two sessions with three months between each session period. Each session includes the following: pre-testing and imaging, tDCS 3-week session, post-testing and imaging. Participants will complete an initial screening to confirm clinical diagnosis of ASD, determine baseline cognitive functioning, and complete a practice Magnetic Resonance Imaging (MRI) and Magnetoencephalography (MEG) session. At pre-testing, they will complete a psychometric battery, as well as undergo safety screening, and an MRI and/or MEG. Each 3-week tDCS sessions will be randomized, and each participant will undergo three weeks of sham stimulation and three weeks of 20-minute tDCS stimulation. Neither the researchers nor the participants will know which group they are assigned during each three-week session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcranial direct current stimulation (tDCS), then sham stimulation | Experimental | Device: trans cranial direct current stimulation (tDCS), Device: ShamParticipants receives three weeks of 20-minute tDCS stimulation. After a washout period of 3 months, they then receive three weeks of sham stimulation |
| Sham stimulation, then transcranial direct current stimulation (tDCS) | Experimental | Device: trans cranial direct current stimulation (tDCS), Device: ShamParticipants receives three weeks of sham stimulation. After a washout period of 3 months, they then receive three weeks of 20-minute tDCS stimulation |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Ages 5 to 21, male and female, with known autism spectrum disorder as diagnosed by a clinician
Key exclusion criteria (7 listed)
- Pregnancy
- Brain implants
- Pacemakers
- Any biomedical or metal implants in any part of body
- Hearing or visual impairment
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 |
|---|---|---|
| trans cranial direct current stimulation (tDCS)Three weeks of 20-minute tDCS stimulation | Device | Sham stimulation, then transcranial direct current stimulation (tDCS), transcranial direct current stimulation (tDCS), then sham stimulation |
| ShamThree weeks of sham stimulation | Device | Sham stimulation, then transcranial direct current stimulation (tDCS), transcranial direct current stimulation (tDCS), then sham stimulation |
Primary outcome
Social behavior as measured by Reading the Mind in the Eyes (RME) Child Version
Time frame: Baseline
Reading the Mind in the Eyes (RME) Child Version will be used to measure complex mental state recognition. This test consists of 28 photographs of the eye region of the human face, each surrounded by four words. Participants pick the word that best describes what the person in the photo is thinking or feeling. Scores range from 0-28, higher score indicates very accurate at decoding a person's facial expressions around their eyes.
Social behavior as measured by Reading the Mind in the Eyes (RME) Child Version
Time frame: Post Treatment (approx at 3 month)
Reading the Mind in the Eyes (RME) Child Version will be used to measure complex mental state recognition. This test consists of 28 photographs of the eye region of the human face, each surrounded by four words. Participants pick the word that best describes what the person in the photo is thinking or feeling. Scores range from 0-28, higher score indicates very accurate at decoding a person's facial expressions around their eyes.
Social behavior as measured by Cyberball/Social Ball Throwing Task
Time frame: Baseline
Cyberball/Social Ball Throwing Task will be used to measure social interaction. In this task, the participant engaged in a virtual ball throwing game with two other players. There are three conditions the participants will be randomly assigned to. In two conditions participants are thrown the ball an equal number of times, in the other condition the participant is only thrown the ball a few times. After the participant completes the task, they are given a rating scale to rate how well they trust and prefer the other two players on a scale from 1-7 (totally mistrust to totally trust). The ratings indicated how well the subject was able to determine if they were left out of the group"
Social behavior as measured by Cyberball/Social Ball Throwing Task
Time frame: Post Treatment (approx at 3 month)
Cyberball/Social Ball Throwing Task will be used to measure social interaction. In this task, the participant engaged in a virtual ball throwing game with two other players. There are three conditions the participants will be randomly assigned to. In two conditions participants are thrown the ball an equal number of times, in the other condition the participant is only thrown the ball a few times. After the participant completes the task, they are given a rating scale to rate how well they trust and prefer the other two players on a scale from 1-7 (totally mistrust to totally trust). The ratings indicated how well the subject was able to determine if they were left out of the group"
Sensorimotor behavior as measured by Grip Strength
Time frame: Baseline
Participants grip a specially designed fiber optic device (Aither Engineering, Inc.). This device detects nanometer changes in grip force which are calibrated in Newtons. Participants are instructed to rest their arm in a relaxed position. Subjects use their thumb and index finger to press against grip device. Prior to testing, each subject will complete the maximum voluntary contraction for each hand during trials of 3 seconds each with 15 seconds in between each trial. The subject is then instructed to press as hard as they can when the screen says "go" using only the thumb and pointer finger.
Sensorimotor behavior as measured by Grip Strength
Time frame: Post Treatment (approx at 3 month)
Participants grip a specially designed fiber optic device (Aither Engineering, Inc.). This device detects nanometer changes in grip force which are calibrated in Newtons. Participants are instructed to rest their arm in a relaxed position. Subjects use their thumb and index finger to press against grip device. Prior to testing, each subject will complete the maximum voluntary contraction for each hand during trials of 3 seconds each with 15 seconds in between each trial. The subject is then instructed to press as hard as they can when the screen says "go" using only the thumb and pointer finger.
Sensorimotor behavior as measured by Reach Task
Time frame: Baseline
Participants will be positioned at a table with reaching arm resting on the table in a neutral position. The task includes picking up small objects placed on the table and placing the objects one by one into a target container in two trials: preferred and non-preferred hands. The task is rated on a 6-point rating scale, where 5 represents weakest performance, and 0 represents best performance. Each item is given a raw score and a standard score, which translate to a component score and percentile rank.
Sensorimotor behavior as measured by Reach Task
Time frame: Post Treatment (approx at 3 month)
Participants will be positioned at a table with reaching arm resting on the table in a neutral position. The task includes picking up small objects placed on the table and placing the objects one by one into a target container in two trials: preferred and non-preferred hands. The task is rated on a 6-point rating scale, where 5 represents weakest performance, and 0 represents best performance. Each item is given a raw score and a standard score, which translate to a component score and percentile rank.
Sensorimotor behavior as measured by Sensory Profile-2
Time frame: Baseline
A parent self-report form designed to assess sensory processing patterns in children and adolescents. The report includes three subscales: sensory system, behavior, and sensory pattern.Each item is scored on a Likert scale from 1 to 5 (1=Much Less Than Others, 2=Less Than Others, 3=Just Like the Majority of Others, 4=More Than Others, 5=Much More Than Others). Raw scores are totaled and converted to percentile ranks based on participant age.
Sensorimotor behavior as measured by Sensory Profile-2
Time frame: Post Treatment (approx at 3 month)
A parent self-report form designed to assess sensory processing patterns in children and adolescents. The report includes three subscales: sensory system, behavior, and sensory pattern.Each item is scored on a Likert scale from 1 to 5 (1=Much Less Than Others, 2=Less Than Others, 3=Just Like the Majority of Others, 4=More Than Others, 5=Much More Than Others). Raw scores are totaled and converted to percentile ranks based on participant age.
Neurophysiological impacts as measured by Magnetoencephalography (MEG)
Time frame: Baseline
MEG data will be processed using AFNI (https://afni.nimh.nih.gov/). Using all channels of the MEG data, strength and latency of responses are measured by transforming each subject's raw MEG activity into brain space. A spatial filter is applied which separates the source activity from different brain regions to observe overlap at the sensor level. This analysis will assess functional connectivity between the region of interest (ROI) voxel, the right Crus I of the cerebellum, compared to all other voxels in the brain. Seed-based voxel correlation analysis enables researchers to see the statistical correlation between the ROI activity and activity in other cortical areas. This correlation reveals patterns of connectivity between the ROI and other cortical regions. The second level analysis will utilize a one-way ANOVAs will compare baseline measures (Cyberball, Precision Grip) and demographics (e.g. age) within groups. The within subjects' effect of tDCS on task scores will be evaluated
Neurophysiological impacts as measured by Magnetoencephalography (MEG)
Time frame: Post Treatment (approx at 3 month)
MEG data will be processed using AFNI (https://afni.nimh.nih.gov/). Using all channels of the MEG data, strength and latency of responses are measured by transforming each subject's raw MEG activity into brain space. A spatial filter is applied which separates the source activity from different brain regions to observe overlap at the sensor level. This analysis will assess functional connectivity between the region of interest (ROI) voxel, the right Crus I of the cerebellum, compared to all other voxels in the brain. Seed-based voxel correlation analysis enables researchers to see the statistical correlation between the ROI activity and activity in other cortical areas. This correlation reveals patterns of connectivity between the ROI and other cortical regions. The second level analysis will utilize a one-way ANOVAs will compare baseline measures (Cyberball, Precision Grip) and demographics (e.g. age) within groups. The within subjects' effect of tDCS on task scores will be evaluated
Neurophysiological impacts as measured by functional magnetic resonance imaging (fMRI)
Time frame: Baseline
fMRI data will be processed using AFNI (https://afni.nimh.nih.gov/). A regression analyses is used (3dDeconvolve and 3dREML) for each subject. Data collected from MRI acquisition will be analyzed at two levels. The first level of analysis will use seed-based voxel correlational analysis, a statistical technique for observing differences in brain activity. This analysis will assess functional connectivity between the region of interest (ROI) voxel, the right Crus I of the cerebellum, compared to all other voxels in the brain. Seed-based voxel correlation analysis enables researchers to see the statistical correlation between the ROI activity and activity in other cortical areas. This correlation reveals patterns of connectivity between the ROI and other cortical regions. The second level analysis will utilize a one-way ANOVAs will compare baseline measures (Cyberball, Precision Grip) and demographics (e.g. age) within groups.
Neurophysiological impacts as measured by functional magnetic resonance imaging (fMRI)
Time frame: Post Treatment (approx at 3 month)
fMRI data will be processed using AFNI (https://afni.nimh.nih.gov/). A regression analyses is used (3dDeconvolve and 3dREML) for each subject. Data collected from MRI acquisition will be analyzed at two levels. The first level of analysis will use seed-based voxel correlational analysis, a statistical technique for observing differences in brain activity. This analysis will assess functional connectivity between the region of interest (ROI) voxel, the right Crus I of the cerebellum, compared to all other voxels in the brain. Seed-based voxel correlation analysis enables researchers to see the statistical correlation between the ROI activity and activity in other cortical areas. This correlation reveals patterns of connectivity between the ROI and other cortical regions. The second level analysis will utilize a one-way ANOVAs will compare baseline measures (Cyberball, Precision Grip) and demographics (e.g. age) within groups.
6 secondary outcomes
Executive functioning as measured by Flanker Inhibitory Control and Attention
Time frame: Baseline
Executive functioning as measured by Flanker Inhibitory Control and Attention
Time frame: Post Treatment (approx at 3 month)
Executive functioning as measured by Dimensional Card Change Sort
Time frame: Baseline
Executive functioning as measured by Dimensional Card Change Sort
Time frame: Post Treatment (approx at 3 month)
Working memory as measured by Stanford Binet-V Working Memory Subtest
Time frame: Baseline
Working memory as measured by Stanford Binet-V Working Memory Subtest
Time frame: Post Treatment (approx at 3 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 30 Oct 2026.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trans cranial direct current stimulation (tDCS) in people with Autism Spectrum Disorder, run by University of Texas Southwestern Medical Center 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 1 inclusion and 7 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 30 Oct 2026. 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. 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 Haley Walker (214-797-6454, Autism@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social behavior as measured by Reading the Mind in the Eyes (RME) Child Version (time frame: Baseline). The study lists 14 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 30 Oct 2026.