AutismNCT05396352
Cerebellum and Autism: Regional Specialization for Social and Executive Functions
A study testing Transcranial direct current stimulation in people with Autism and Autism Spectrum Disorder, run by American University at 1 site in United States.
Trial summary
The goal of this study is to determine the impact of neuromodulation to the cerebellum on social and executive functions in neurotypical young adults and young adults with autism. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 31 Dec 2025
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants
- Aged 18-35
- Able to provide written, informed consent
- NIH Toolbox age-adjusted Cognitive Function Composite standard score ≥ 85
- Native English speaker
- Right-handed
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- Not pregnant
- Able to attend all study sessions
- Pass safety screening for MRI and neuromodulation (e.g. no metal in body, implanted devices, history of seizure, claustrophobia)
- Additional INCLUSION criteria for adults with autism Either
- Prior research-reliable diagnosis of autism spectrum disorder (ASD) Or
- Meet DSM-5 criteria for ASD confirmed with ADOS-2 via research-reliable clinical assessment
Who cannot join
- Neurotypical adults
- Age <18 or >35
- NIH Toolbox age-adjusted Cognitive Function Composite standard score < 85
- Contraindications for MRI or neuromodulation with tDCS (e.g. metal in body, pacemaker or other implanted device, history of seizure, claustrophobia)
- Current or prior history of neurological or neurodevelopmental condition or brain injury
- Psychotropic medication
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- Pregnancy
- Adults with autism
- Age <18 or >35
- Participants with a legal authorized representative
- NIH Toolbox age-adjusted Cognitive Function Composite standard score < 85
- Contraindications for MRI or neuromodulation with tDCS (e.g. metal in body, pacemaker or other implanted device, history of seizure, claustrophobia)
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Joe Dust, M.Sc. contact
United States1 site, 1 recruiting
- Recruiting
American University
Washington D.C., District of Columbia, 20016
Catherine Stoodley, D.Phil., 202-885-1785, stoodley@american.edu
Catherine Stoodley
About this study
The goal of this study is to determine the impact of neuromodulation to the cerebellum on social and executive functions in neurotypical young adults and young adults with autism.
Read the detailed description
Autism spectrum disorder is a prevalent neurodevelopmental condition characterized by deficits in social communication and the presence of repetitive and inflexible behaviors. There are currently few biologically-targeted treatment options for autism, in part because the underlying neurobiology is not well understood. One region of the brain that is consistently implicated in autism is the cerebellum. Specifically, two cerebellar subregions show structural and functional differences in autism: right cerebellar lobule VII (RVII) and the posterior cerebellar vermis. Based on the different anatomical connectivity of these regions, the investigators hypothesize that RVII and the posterior vermis regulate different core deficits in autism. In this study, the investigators combine cerebellar neuromodulation with functional neuroimaging to test the hypothesis that neuromodulation targeting RVII will selectively alter social learning and neural networks supporting social behavior, while neuromodulation targeting the posterior vermis will impact cognitive flexibility and neural networks involved in the allocation of attention. Neurotypical adults and adults with autism will complete social and cognitive flexibility tasks after excitatory, inhibitory, or sham neuromodulation in a within-subjects design. Some participants will receive neuromodulation targeting RVII and others will receive neuromodulation targeting the posterior vermis. The investigators will acquire functional brain imaging data during and after cerebellar neuromodulation, which will allow the team to better understand the mechanisms by which non-invasive neuromodulation might impact behavior in clinical disorders.
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- Transcranial direct current stimulation
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Also called tDCS
TDCS involves applying small (1-2 mA) electric currents to the scalp in order to transiently modify local neuronal electrical potentials in the brain.
| Study group | Role | What they receive |
|---|---|---|
| Right cerebellum | Experimental | Participants (neurotypical, autistic) in this arm will receive tDCS targeting the right posterolateral cerebellum (lobule VII). All participants will receive anodal, cathodal and sham tDCS. Receives: Device: Transcranial direct current stimulation |
| Posterior vermis | Experimental | Participants (neurotypical, autistic) in this arm will receive tDCS targeting the posterior cerebellar vermis. All participants will receive anodal, cathodal and sham tDCS. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading the Mind in the Eyes Test Adult Version
Measured: Within 30min post-tDCS
Cyberball social ball-playing task
Measured: Within 30min post-tDCS
Flexible Item Selection Test
Measured: Within 30min post-tDCS
Functional MRI data
Functional MRI task data and resting state functional connectivity data
Measured: Within 45min post-tDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Within-subjects design (active, sham tDCS) with separate groups receiving tDCS targeting cerebellar right lobule VII and the posterior cerebellar vermis.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Catherine Stoodley, American University
- Investigators
- Kathleen Gunthert, Ph.D., Principal investigator, American University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396352
- Sponsor's protocol ID
- R15MH126404
- Other IDs
- R15MH126404
- Status last verified
- Sep 2025
- First submitted
- 25 May 2022
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data, including scores of behavioral tests and skull-stripped brain images, may be shared upon personal request after initial manuscripts based on this work have been published. Individuals wishing to use these data must agree not to attempt to identify participants or redistribute the data, to destroy the data after analyses are completed, and to acknowledge the data resource in any presentations or publications. For participants that consent to having their de-identified data shared with the National Database for Autism Research (NDAR), we will submit data to NDAR in accordance with the NIH guidelines (http://ndar.nih.gov/contribute.html).
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebellum and Autism: Regional Specialization for Social and Executive Functions
- ClinicalTrials.gov ID
- NCT05396352
- Acronym / sponsor ID
- R15MH126404
- Conditions
- Autism, Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- American UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine the impact of neuromodulation to the cerebellum on social and executive functions in neurotypical young adults and young adults with autism.
Detailed description
Autism spectrum disorder is a prevalent neurodevelopmental condition characterized by deficits in social communication and the presence of repetitive and inflexible behaviors. There are currently few biologically-targeted treatment options for autism, in part because the underlying neurobiology is not well understood. One region of the brain that is consistently implicated in autism is the cerebellum. Specifically, two cerebellar subregions show structural and functional differences in autism: right cerebellar lobule VII (RVII) and the posterior cerebellar vermis. Based on the different anatomical connectivity of these regions, the investigators hypothesize that RVII and the posterior vermis regulate different core deficits in autism. In this study, the investigators combine cerebellar neuromodulation with functional neuroimaging to test the hypothesis that neuromodulation targeting RVII will selectively alter social learning and neural networks supporting social behavior, while neuromodulation targeting the posterior vermis will impact cognitive flexibility and neural networks involved in the allocation of attention. Neurotypical adults and adults with autism will complete social and cognitive flexibility tasks after excitatory, inhibitory, or sham neuromodulation in a within-subjects design. Some participants will receive neuromodulation targeting RVII and others will receive neuromodulation targeting the posterior vermis. The investigators will acquire functional brain imaging data during and after cerebellar neuromodulation, which will allow the team to better understand the mechanisms by which non-invasive neuromodulation might impact behavior in clinical disorders.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Within-subjects design (active, sham tDCS) with separate groups receiving tDCS targeting cerebellar right lobule VII and the posterior cerebellar vermis.
| Arm | Type | Receives |
|---|---|---|
| Right cerebellum | Experimental | Device: Transcranial direct current stimulationParticipants (neurotypical, autistic) in this arm will receive tDCS targeting the right posterolateral cerebellum (lobule VII). All participants will receive anodal, cathodal and sham tDCS. |
| Posterior vermis | Experimental | Device: Transcranial direct current stimulationParticipants (neurotypical, autistic) in this arm will receive tDCS targeting the posterior cerebellar vermis. All participants will receive anodal, cathodal and sham tDCS. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- All participants
- Aged 18-35
- Able to provide written, informed consent
- NIH Toolbox age-adjusted Cognitive Function Composite standard score ≥ 85
- Native English speaker
Key exclusion criteria (13 listed)
- Neurotypical adults
- Age <18 or >35
- NIH Toolbox age-adjusted Cognitive Function Composite standard score < 85
- Contraindications for MRI or neuromodulation with tDCS (e.g. metal in body, pacemaker or other implanted device, history of seizure, claustrophobia)
- Current or prior history of neurological or neurodevelopmental condition or brain injury
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 stimulationAlso: tDCSTDCS involves applying small (1-2 mA) electric currents to the scalp in order to transiently modify local neuronal electrical potentials in the brain. | Device | Posterior vermis, Right cerebellum |
Primary outcome
Reading the Mind in the Eyes Test Adult Version
Time frame: Within 30min post-tDCS
Cyberball social ball-playing task
Time frame: Within 30min post-tDCS
Flexible Item Selection Test
Time frame: Within 30min post-tDCS
Functional MRI data
Time frame: Within 45min post-tDCS
Functional MRI task data and resting state functional connectivity data
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 2 Oct 2025.
- Individual participant dataSharing planned: Yes. De-identified data, including scores of behavioral tests and skull-stripped brain images, may be shared upon personal request after initial manuscripts based on this work have been published. Individuals wishing to use these data must agree not to attempt to identify participants or redistribute the data, to destroy the data after analyses are completed, and to acknowledge the data resource in any presentations or publications. For participants that consent to having their de-identified data shared with the National Database for Autism Research (NDAR), we will submit data to NDAR in accordance with the NIH guidelines (http://ndar.nih.gov/contribute.html).
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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.
Joe Dust, M.Sc. contact
Kathleen Gunthert, Ph.D. principal investigator
American University
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 in people with Autism and Autism Spectrum Disorder, run by American University 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 12 inclusion and 13 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 2 Oct 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. 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 Catherine Stoodley, D.Phil. (202-476-4799, stoodley@american.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading the Mind in the Eyes Test Adult Version (time frame: Within 30min post-tDCS). The study lists 4 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 2 Oct 2025.