Cerebellum and Autism: Regional Specialization for Social and Executive Functions
Primary Purpose
Autism, Autism Spectrum Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Autism
Eligibility Criteria
Inclusion Criteria:
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
- 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
Exclusion Criteria:
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
- 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
Sites / Locations
- American UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Right cerebellum
Posterior vermis
Arm Description
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.
Participants (neurotypical, autistic) in this arm will receive tDCS targeting the posterior cerebellar vermis. All participants will receive anodal, cathodal and sham tDCS.
Outcomes
Primary Outcome Measures
Reading the Mind in the Eyes Test Adult Version
Cyberball social ball-playing task
Flexible Item Selection Test
Functional MRI data
Functional MRI task data and resting state functional connectivity data
Secondary Outcome Measures
Full Information
NCT ID
NCT05396352
First Posted
May 25, 2022
Last Updated
July 18, 2023
Sponsor
American University
Collaborators
National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05396352
Brief Title
Cerebellum and Autism: Regional Specialization for Social and Executive Functions
Official Title
Cerebellum and Autism: Regional Specialization for Social and Executive Functions
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University
Collaborators
National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Autism Spectrum Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Within-subjects design (active, sham tDCS) with separate groups receiving tDCS targeting cerebellar right lobule VII and the posterior cerebellar vermis.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Right cerebellum
Arm Type
Experimental
Arm Description
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.
Arm Title
Posterior vermis
Arm Type
Experimental
Arm Description
Participants (neurotypical, autistic) in this arm will receive tDCS targeting the posterior cerebellar vermis. All participants will receive anodal, cathodal and sham tDCS.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Other Intervention Name(s)
tDCS
Intervention Description
TDCS involves applying small (1-2 mA) electric currents to the scalp in order to transiently modify local neuronal electrical potentials in the brain.
Primary Outcome Measure Information:
Title
Reading the Mind in the Eyes Test Adult Version
Time Frame
Within 30min post-tDCS
Title
Cyberball social ball-playing task
Time Frame
Within 30min post-tDCS
Title
Flexible Item Selection Test
Time Frame
Within 30min post-tDCS
Title
Functional MRI data
Description
Functional MRI task data and resting state functional connectivity data
Time Frame
Within 45min post-tDCS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Please note: This study takes place at American University and Georgetown University in Washington, DC. We do not have funds for travel and lodging available for this study, so participants should be local to the DC region.
Inclusion Criteria:
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
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Stoodley, D.Phil.
Phone
202-885-1785
Email
stoodley@american.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Stoodley, D.Phil.
Organizational Affiliation
American University
Official's Role
Principal Investigator
Facility Information:
Facility Name
American University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Stoodley, D.Phil.
Phone
202-885-1785
Email
stoodley@american.edu
First Name & Middle Initial & Last Name & Degree
Catherine Stoodley
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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).
IPD Sharing Time Frame
Data uploaded to NDAR will be released following study completion
IPD Sharing Access Criteria
Access to NDAR
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.
IPD Sharing URL
http://nda.nih.gov
Learn more about this trial
Cerebellum and Autism: Regional Specialization for Social and Executive Functions
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