Cerebellar tDCS for Children with Autism Spectrum Disorder
This study, called the Raynor Cerebellum Project, is looking at how transcranial direct current stimulation (tDCS) might help children and young adults with Autism Spectrum Disorder (ASD). tDCS is a non-invasive brain stimulation technique. The study will compare three weeks of active tDCS stimulation to three weeks of sham stimulation (a very low level of stimulation that feels similar but has no effect). Researchers want to see if tDCS can improve social behavior, which will be measured using tasks like "Reading the Mind in the Eyes" and "Cyberball." You may be able to join if you are between 5 and 21 years old and have a diagnosed autism spectrum disorder. The study is currently recruiting up to 60 participants, but its overall status is unclear.
- Study design
- This is an interventional study with a randomized, double-blind, within-subject crossover design, planning to enroll up to 60 participants.
- What's involved
- You would have an initial screening, followed by two sessions separated by three months. Each session includes pre-testing, three weeks of daily 20-minute tDCS or sham stimulation, and post-testing.
- Compensation
- Not stated in the trial record.
- Follow-up
- Social behavior will be measured at baseline and again approximately three months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder: Raynor Cerebellum Project
At a glance
Conditions
NCT05691283
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
UT Southwestern Medical Center
Dalls, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Peter Tsai, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Social behavior as measured by Reading the Mind in the Eyes (RME) Child VersionBaseline
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 VersionPost 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 TaskBaseline
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 TaskPost 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 StrengthBaseline
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 StrengthPost 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 TaskBaseline
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 TaskPost 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-2Baseline
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-2Post 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)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)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)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)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.