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.