The Effects of ProFoveate on Reducing Self-Stimulating Behaviors in Children Diagnosed With Autism Spectrum Disorders
Phase: NA
Conditions: Autism Spectrum Disorders, Normal Hearing, Normal Intelligence, Exhibit Self- Stimulating or Ritualistic Behaviors
Sponsor: University of Arkansas

TITLE:  The Effects of ProFoveate TM on Reducing Self- Stimulating Behaviors In Children Diagnosed With Autism Spectrum Disorders. 
PI: Atcherson, S. 
Co-I: Gentry, B. 
Version 4, 9.8.14 
 
 
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RESEARCH PROTOCOL 
 
TITLE:  The Effects of ProFoveate TM on Reducing Self- Stimulating Behaviors In Children Diagnosed With    
             Autism Spectrum Disorders 
 
PRINCIPAL INVESTIGATOR:  Samuel Atcherson, Ph.D. 
 
 
 
      Associate Professor, UALR/UAMS 
 
 
 
      Department of Audiology and Speech Pathology/CHP 
     
 
      Email:  sratcherson@ualr.edu  
      Office Phone: 683-7178 
 
 
 
      FAX:  501-569-3157 
 
Co-INVESTIGATOR: 
      Betholyn Gentry, Ph.D. 
 
 
 
      Professor, UAMS/UALR 
 
 
 
      Department of Audiology and Speech Pathology/CHP  
 
 
 
      Email:  gentrybetholynf@uams.edu 
                                                 Office Phone:  569-8913 
 
 
 
 
      FAX:  501-569-3157 
 
Study Physician:                    Eldon Schulz, M.D.     
                                                 Professor, Department of Pediatrics/ COM 
                                                 Telephone:  364-1836  
                                                 schulzeldon@uams.edu 
 
 
 
Medical Monitor:  
     Tom Wells, M.D., M.B.A. 
 
 
     
     Professor, Department of Pediatrics/ COM 
     Telephone:  603-1638 
     E-mail:  wellsthomasg@uams.edu 
 
 
 
 
LOCATION: 
 
     University of Arkansas at Little Rock Speech and Hearing Clinic 
 
 
 
 
 
 
 
 
 
 
 

TITLE:  The Effects of ProFoveate TM on Reducing Self- Stimulating Behaviors In Children Diagnosed With Autism Spectrum Disorders. 
PI: Atcherson, S. 
Co-I: Gentry, B. 
Version 4, 9.8.14 
 
 
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RESEARCH PLAN 
 
Background and Significance/Rationale 
Autism Spectrum Disorder (ASD) is a developmental neurological disorder that impairs basic behaviors 
such as communication and social interactions and often manifests itself in restricted or repetitive 
behaviors (American Psychiatric Association, 2000). The word “spectrum” accurately defines this 
disorder as it can range from severe impairment to mild dysfunction.  In recent years, the number of 
children diagnosed with Autism Spectrum Disorder has increased, with the latest prevalence figures 
estimating an average of 1 in 50 children (Centers for Disease Control and Prevention [CDC], 2013). ASD 
is characterized by impairment in communication skills, social interaction, and behavior.  As the overall 
prevalence has continued to rise, so has the demand for innovative intervention (Fombonne, 2005; 
Newschaffer, Falb, & Gurney, 2005; Rice, 2009; Wing & Potter, 2002; Smith, Press, Koenig, and 
Kinnealey, 2005; Sutherland & Crewther, 2010).   
 
Among the many challenges for individuals with ASD is the tendency to engage in self-stimulating, or 
stereotypic behaviors.  Often these behaviors can pose deterrents to social interaction with typical 
peers, especially for high functioning (HF) individuals with ASD.  For the purpose of this study individuals 
with high functioning ASD have average to above average intelligence.  Self-stimulating behaviors can 
serve as coping mechanisms for the individual with ASD and may pose a life long struggle. These 
behaviors can be a major concern to parents, peers, and professionals working with this population of 
individuals.  Researchers have examined self-stimulating behaviors for several years.  Harris & Wolchik 
(1979) identified several self-stimulating behaviors in children with autism which included behaviors like 
hand flapping, twisting ear, finger manipulations, and repetitive rubbing of hands and face.  Turner 
(1999) divided these self-stimulating into lower level behaviors that are characterized by repetition of 
movement, and more complex and high-level behaviors that are characterized by object attachment and 
insistence on sameness.  Later, Kennedy, Meyer, Knowles, & Shukla (2000) reported that in some 
individuals these behaviors are associated with environmental stimulation, and in other individuals 
these behaviors are associated with negative reinforcement and the absence of environmental 
stimulation.  Militerni, et al, (2002) found that the majority of the children with ASD exhibited more than 
one repetitive behavior.   Therefore, management of self-stimulating behaviors can impact the quality of 
life for individuals with ASD.   Several techniques have been tried to eliminate self-stimulating behaviors 
in individuals with autism with varying degrees of success: time out, overcorrection, differential 
reinforcement of other behaviors (Harris & Wolchik, 1979); behavior modification (Matson & Lovullo, 
2010); exercise (Watters & Watters, 1990; Rosenthal-Malek & Mitchell, 1997); and weighted vest 
(Fertel-Daly, Bedell & Hinojosa 2001).  More recently, Smith, Press, Koenig, and Kinnealey (2005) found 
that repetitive behaviors were reduced after Sensory Integration therapy.  We are interested in applying 
a new intervention procedure called ProFoveate™. 
 
ProFoveate™ intervention for nystagmus is a management approach comprised, in part, of non-
magnetic, 1.2 mm steel spheres (see below) placed strategically about the face and ears and a set of 
exercises designed to support improved vision for patients with nystagmus.  The developers have shown 
in a provisional patent that the strategic placement of the press pellets or patches containing one or 
more pellets, which may be affixed to the skin of the patient, can greatly enhance the visual acuity of 
the wearer with nystagmus.  Studies have shown that children with ASD and children with nystagmus 
share a resistance to post-rotary nystagmus (Happe & Frith, 1996; Nelson, Nitzberg & Hallander, 1980; 
Ornitz, Brown, Mason & Putman, 1974). Responses to vestibular stimulation such as that provided by 
rotary testing of the individual can provide an assessment of brain stem function.  Ornitz, Atwell, Kaplan 
& Westlake, 1985) found that children with autism had significantly longer time constants during the 

TITLE:  The Effects of ProFoveate TM on Reducing Self- Stimulating Behaviors In Children Diagnosed With Autism Spectrum Disorders. 
PI: Atcherson, S. 
Co-I: Gentry, B. 
Version 4, 9.8.14 
 
 
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primary nystagmus response and significantly fewer beats during the secondary response than normal 
children when stimulated with constant angular acceleration in complete darkness.  The greater length 
of time shows the resistance to nystagmus in this group.  It is believed that enhanced stimulation of the 
Occiput point, which is best accessed behind the ear, could reduce self-stimulating behaviors in  children 
with autism and increase a sense of calm more conducive to learning and social interaction.  Roussi, et. 
al., (2011) demonstrated the importance of electrophysiological measures in making a diagnosis in 
patients with congenital nystagmus. Congenital nystagmus is an ocular oscillation that usually appears in 
early infancy. It is most often, but not always, seen in association with visuosensory abnormalities 
(Gelbart & Hoyt, 1998).  ProFoveate™ has provided the visual acuity often sought through surgery in 
patients diagnosed with congenital nystagmus. The potential use of this product in patients with autism 
has not been explored to date. There is some evidence in the literature to suggest that vestibular 
stimulation may have an impact on behavior and neural activity in children with ASD (Grandin, 1996; 
Ornitz et.al., 1985; Ornitz, Guthrie & Farley, 1977; Ornitz, Brown, Mason & Putnam, 1974; Miller, 
Reisman, McIntosh, & Simon, 2001; Ray, King & Grandin, 1988).  However, this study represents a 
unique application of the ProFoveate™ pellets and has the potential to help individuals with ASD 
manage self-stimulating behaviors like hand flapping, eye blinking, rocking, staring, etc., which can be 
deterrents to social interaction.   
 
Individuals diagnosed with Autism spectrum disorders (ASD) often show patterns of restrictive and 
repetitive behaviors, reflecting a difficulty to inhibit excess sensory information in the brain. This 
information suggests sensory gating may be affecting some of the visible symptoms of ASD (Perry, 
Minassian, Lopex, & Lincoln (2007).  Sensory gating describes neurological processes of filtering out 
redundant or unnecessary stimuli in the brain from all possible environmental stimuli, and prevents an 
overload of irrelevant information in the higher cortical centers of the brain. Current research on this 
topic is limited.  An established method of evaluating brain activity is the use of event-related potentials 
(ERPs). ERPs are positive and negative voltage fluctuations (or components) in ongoing 
electroencephalograms (EEG) that are time-locked to the onset of a sensory, motor, or cognitive 
event.   ERPs reflect brain activity that is specifically related to some stimulus or other event. ERPs are 
voltage fluctuations that are associated in time with some physical or mental occurrence. These 
potentials can be recorded from the human scalp and extracted from the ongoing 
electroencephalogram (EEG) by means of filtering and signal averaging (Picton et al., 2000).  The results 
of EEG can be useful in documenting any changes in neural activity following the ProFoveate™ 
intervention. 
 
Protocol Summary 
 
Specific Aims/Objectives 
The purpose of this study is to document the effects of ProFoveate™ intervention on the occurrence of 
self-stimulating behaviors and social skills in children diagnosed with high functioning autism spectrum 
disorders (HFASD).  This study can potentially help researchers understand how to help reduce socially 
distracting self-stimulating behaviors in this group. There may even be evidence that changes in 
behavior may be reflected in changes in the brain. 
 
The specific aim of this study is to: 
1. Examine and describe the impact of the ProFoveate™ intervention on parents’ perceptions of 
self-stimulating behaviors and social interaction skills in their children diagnosed with HFASD 
and document any changes in brain activity. 
 

TITLE:  The Effects of ProFoveate TM on Reducing Self- Stimulating Behaviors In Children Diagnosed With Autism Spectrum Disorders. 
PI: Atcherson, S. 
Co-I: Gentry, B. 
Version 4, 9.8.14 
 
 
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Specific Research questions are: 
1. Are there differences between the HFASD experimental and HFASD control group in the 
occurrence of self-stimulating behaviors as reported by caregivers, following ProFoveate™ 
intervention? 
2. Are there differences between the HFASD experimental and HFASD control group in social 
interaction skills as reported by caregivers, following ProFoveate™ intervention? 
3. Are there electrophysiological changes in the brains of individuals with HFASD in the control 
group compared to HFASD individuals in the experimental group, as measured by EEGs 
following ProFoveate™ intervention? 
 
The long term goal of this line of research is to determine if the supposition that the ProFoveate™ 
intervention is beneficial to children with HFASD is substantiated by evidence from parent report of 
changes in self-stimulating behaviors and social interaction skills as well as by measures of change in 
neural activity in the experimental group.  The first step in this process is to conduct a pilot study.  
Depending on the findings of this pilot study, future studies may be conducted with modifications to the 
procedures and more participants. 
 
Test Article 
 
Investigational Device 
ProFoveate™ intervention for nystagmus is a management approach comprised of non-magnetic, 1.2 
mm spheres that can be made from either stainless steel, gold or silver plated stainless steel or titanium, 
placed strategically about the face and ears and a set of exercises designed to support improved vision 
for patients with nystagmus.  The spheres chosen for this study will be five pellet patches.  We decided 
to use five pellet patches to ensure proper placement on the occiput with our target minor population.  
These multi pellet patches are 0.5” x 0.5” adhesive plasters that contain latex.  Each patch features a 
geometrically spaced cluster of five 1.2 mm silver plated pellets.   They are available from Lhasa OMS at 
http://www.lhasaoms.com/ and come in packet of 50 pellets.  We will give each participant one packet 
of 50 five pellet patches which will be enough for the study time frame.  Any unused pellets will be 
returned.  Individual patches (with adhesive tape) are removed from the backing as needed according to 
the prescribed treatment regimen. (See Figure 1) 
 
 
Figure 1: ProFoveate Five Pellet Patches http://www.lhasaoms.com/  
 
Within this study, HFASD participants assigned to the experimental group will wear the silver plated 
stainless steel ProFoveate™ pellets strategically placed on their ears and held in place by the adhesive 
tape continuously for four weeks.  
 
Study Treatment Instructions 
Parents of children assigned to the experimental group will be given instructions on how to use the 
ProFoveate™ pellets. The follow instructions will be included on a brochure (See supporting materials) 
and given to parents of children in the experimental group during visit 2:  

TITLE:  The Effects of ProFoveate TM on Reducing Self- Stimulating Behaviors In Children Diagnosed With Autism Spectrum Disorders. 
PI: Atcherson, S. 
Co-I: Gentry, B. 
Version 4, 9.8.14 
 
 
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1) The ProFoveate™ pellets are to be placed on the occiput of the right ear as indicated in the 
picture below.  
2) Generally, the ProFoveate™ pellets should be changed every 2 to 3 days or when they fall 
off. 
3) Before applying, the skin should be thoroughly cleaned with alcohol and the tape applied 
with a good seal.  
4)  Check regularly to ensure that the pellets are in place.   
5) Write down the date on the Patient Diary Sheet each time the pellets are checked.   
6) You will be supplied with a packet of 50 pellets to use as needed during the 28 days of 
ProFoveate™ intervention.  All unused pellet are t to be returned during the last visit. 
 
Parents and children will be shown exactly where to place the pellets on the ear.  Specifically, the 
Occiput point will be identified for each participant.  In traditional Chinese medicine, the Occiput point 
on the ear may be used to influence brain and spinal cord function.  Note in particular the proximity of 
the vestibular nerve (yellow) to the skin anterior to the ear canal and medial to the pinna on the ear in 
Figure 2 below.  The Occiput point we want to use is behind the ear and lateral to a projection of the 
vestibular nerve (Figure 3). 
 
 
 
Figure 2.  http://images.emedicinehealth.com/images/eMedicineHealth/illustrations/ear_cutaway.jpg 
 
 
Figure 3:  Occiput point on ear. 
Study Treatment Compliance 
Parents will be provided with a Patient Diary Sheet (see supporting documents) and will be instructed to 
perform and document daily checks for placement of the pellets. 
 

TITLE:  The Effects of ProFoveate TM on Reducing Self- Stimulating Behaviors In Children Diagnosed With Autism Spectrum Disorders. 
PI: Atcherson, S. 
Co-I: Gentry, B. 
Version 4, 9.8.14 
 
 
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Device Dispensing and Disposition  
Parents of each participant in the experimental group will be given a one month supply of silver plated 
stainless steel pellets (50 pellets) following group assignment at the initial study visit.  Used pellets 
(those removed each time the pellets are changed) will be discarded.  Unused pellets will be returned at 
the final study visit. 
 
Study Design and Procedures 
 
Schedule of Time and Events 
 
 
Visit 1  
 
Visit 2 
Study Intervention  
(or no-treatment control) Period 
Visit 3 
 
Visit 4 
Study Procedures 
Day 1 
Day 2 
Days 2-29 
Day 30-34 
Day 30-34 
Informed Consent 
x 
 
 
 
 
Hearing Screening 
x 
 
 
 
 
TONI-4 
x 
 
 
 
 
Randomization 
x 
 
 
 
 
SSIS – Student Form 
x 
 
 
x 
 
TOPL-2 
x 
 
 
x 
 
Parent Questionnaire 
x 
 
 
x 
 
SSIS – Parent Form 
x 
 
 
x 
 
Video Taping 
x 
 
 
x 
 
EEG  
 
x 
 
 
x 
Dispense Test Articlea 
 
x 
 
 
 
Log in returned Test 
Articlea 
 
 
 
 
x 
Study Treatmenta 
 
x 
x 
 
 
Treatment Compliancea 
 
x 
x 
 
 
Adverse Event Review 
 
x 
 
 
x 
EEG = electroencephalography; TONI-4 = Test of Nonverbal Intelligence 4; SSIS = Social Skills Improvement System; 
TOPL-2 = Test of Pragmatic Language -2 
a Only for those subjects assigned to the experimental group 
 
This is a pilot study aimed at examining the effects of ProFoveate™ intervention on reducing some of the 
hallmark characteristics of HFASD.  Specifically, we are interested in documenting any changes in self-
stimulating behaviors or social skills and neural activity as reported by parents and EEGs.  A two group 
control group design will be utilized where both the experimental group and control group of individuals 
with HFASD will receive assessments of self- stimulating behaviors, social skills and neural activity at 
baseline. The experimental group will receive the ProFoveate™ intervention followed by reassessment 
of both the experimental and control groups at the end of the study.  The target participants are 30 
children diagnosed with HFASD between the ages of 10 and 17 years and their parents.  This older age 
group was chosen because the participants must able to apply and monitor the ProFoveate™ pellets.  
Participants will be recruited by sending out flyers (See Flyer attachment) to autism support groups and 
to previous clients of a social skills program at the UALR Speech and Hearing Clinic. Participants who are 
interested in participating will make an appointment.  At that time the consent form will be reviewed 
and any questions will be answered by the principal investigator.  Participants will be given as much time 
as needed to review the consent/assent forms (See consent and assent form attachments).  Those who 
provide consent/assent and have a documented diagnosis of ASD (autism, Asperger’s syndrome, or PDD-
NOS) will be assessed.  Participants will come to the UALR Speech and Hearing Clinic for four visits.  Visit 

TITLE:  The Effects of ProFoveate TM on Reducing Self- Stimulating Behaviors In Children Diagnosed With Autism Spectrum Disorders. 
PI: Atcherson, S. 
Co-I: Gentry, B. 
Version 4, 9.8.14 
 
 
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1 will involve the initial assessments and visit 2 will involve the initial EEG.  Visit 3 will involve final 
assessments and visit Child participants will be assessed using the following measures: 1) hearing 
screening at 25 decibels for the frequencies 1000, 2000 and 4000 hertz; 2) Test of Nonverbal Intelligence 
3 (TONI-3; Brown, Sherbenou & Johnsen, 2009; 3) Social Skills Improvement System SSIS - Student form 
(Gresham & Elliot, 2008); and 4)  Test of Pragmatic Language -2 (TOPL-2; Phelps-Terasaki & Phelps-
Gunn, 2007; See Supporting Materials).  All assessment procedures with each child in Visits 1 and 3 will 
be video recorded and analyzed using the observation of self-stimulating behaviors checklist (See 
Supporting Materials). Additionally, parent participants included in the study will assess their children 
using a standardize measure: 1) the Social Skills Improvement System SSIS - Parent form (Gresham & 
Elliot, 2008) and a non-standardized measure: 2) the Questionnaire for Parents of Children with Autism 
Spectrum Disorders (Gentry, 2013) (developed by the researcher to identify self-stimulating behaviors); 
to assess their children's social skills (See Supporting Materials). Both assessments will be administered 
at the beginning and end of the study.  These assessments are expected to last 2 hours. The twenty-five 
self-stimulating behaviors identified as a concern for this study include: hand flapping, pulling or twisting 
ear, scratching, masturbating, shuffling or tapping feet, chewing clothes, picking or rubbing  clothes, 
sucking finger, playing with hair, vocal noises, mouthing, self-injurious behaviors, head banging , 
rhythmic rocking, twirling objects, tongue rolling and clicking, teeth clicking,  head shaking, knocking 
knees together, gazing at a particular object, repetitive rubbing of mouth and face, finger manipulations, 
locking hands behind head, grimacing , and tensing whole body and shaking.  
 
All qualifying child participants will participate in the PI’s Auditory Electrophysiology and (Re)Habilitation 
Lab located in the UAMS/UALR Department of Audiology and Speech Pathology and is associated with 
the UALR Speech and Hearing Clinic.  Event-related potential (ERP) measures on a multichannel 
Neuroscan evoked potential system (Compumedics UCA, Charlotte, NC) will be taken twice, at the 
beginning and at the end of the study.  ERPs are positive and negative voltage fluctuations (or 
components) that are time-locked to the onset of a sensory, motor, or cognitive event. ERPs are non-
invasive and can be recorded from the human scalp using surface electrodes and extracted 
mathematically from the ongoing electroencephalogram (EEG) by means of filtering and signal averaging 
(Picton et al., 2000). ERPs have been used recently to study various phenomena in normal and 
disordered subject groups with encouraging results (Abel,  Wang, & Dell'Osso, 2008; Andersson, Barder, 
Hellvin, Løvdahl, & Malt, 2008; Balaz, Rektor, & Pulkrabek, 2008; Dichter, van der Stelt, Boch, & Belger, 
2006; Paul et al., 2005; Roth, 2000; Sachs et al., 2004; Sumich et al., 2008). In the proposed study, we 
will elicit the P300 ERP using a visual Stroop task (e.g., Rosenfield & Skogsberg, 2006) and an auditory 
oddball task (e.g., Edelson et al., 1999). After slight cleaning with alchohol pad and EEG skin prep cream, 
participants will have 8 electrolyte paste-filled electrodes (silver-silver chloride) placed on their head 
and secured with medical tape: 3 on the scalp as non-inverting (Fz, Cz, and Pz), 1 on each mastoid and 
linked as inverting input (M1 and M2), 1 on the forehead as ground (Fpz), and 1 above and below each 
eye as for ocular artifact rejection purposes (EOG). Electrode impedances will be checked to ensure they 
are 4 kohms or less. ERPs will be bandpass filtered 0.1 to 30 Hz (12 dB/oct) and sampled 200 times per 
second.   Individual visual ERP measures will be obtained while the participant is engaged in the Stroop 
task (e.g., presentation of color words with a congruent [standard presented 80% of the time] or 
incongruent [target presented 20% of the time] color). Word stimuli (red, blue, green) will be presented 
via computer monitor screen and at the rate of 1.1/s (stimulus duration: 200 ms).  Individual auditory 
ERP measures will be obtained while the participant is engaged in an auditory oddball task using 1000 Hz 
(standard stimuli presented 80% of the time [400 stimuli]) and 2000 Hz (target stimuli presented 20% of 
the time [100 stimuli]) short duration tonebursts. Tonebursts with 40 ms durations (10 ms rise/fall 
times) will be presented binaurally through earphones at 70 dB peak SPL at the rate of 1.1/s. For both 
visual and auditory ERPs (specifically the P300 response), participants will be engaged in a button-

TITLE:  The Effects of ProFoveate TM on Reducing Self- Stimulating Behaviors In Children Diagnosed With Autism Spectrum Disorders. 
PI: Atcherson, S. 
Co-I: Gentry, B. 
Version 4, 9.8.14 
 
 
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pressing task that provides the accuracy of their responses and reaction time. Following EEG recordings, 
ERP analysis time windows will be set post hoc permitting a -100 ms pre-stimulus baseline and a post-
stimulus time that extends well beyond the P300 latency (e.g., epoch of -100 to 700 ms). EEGs will 
undergo ocular artifact rejection and be baseline corrected prior to production of an average to all 
target stimuli. P300 amplitude and latency measures will also be taken. These procedures are expected 
to last no more than one to one and a half hours in a single session or a split session depending on the 
needs of the participant. During the administration of ERP procedure, the PI will not be aware if the 
child participant undergoing the procedure is in the control group or experimental group. This approach 
will support internal validity and minimize the potential for investigator bias.  Sample waveforms 
showing several ERP components, including P300 are presented in Figures 4. 
 
Figure 4 
 
Figure 4: http://en.wikipedia.org/wiki/file:ComponentsofERP.svg 
 
 
Following initial assessment, child participants will be randomly assigned to either the control group (15 
participants) or the experimental group (15 participants).  Participants in the experimental group will be 
required to wear the ProFoveate™ metal pellets held in place by small adhesive bandages strategically 
placed on their ears during days 2-29.  Participants in the experimental will be told to return for the final 
assessment on days 30-34 following cessation of treatment.  Participants in the control group will 
receive no study intervention. Participants in the control group will be told to return for final assessment 
on days 30-34 following initial assessment.  
 
The null hypothesis predicts that there will be no significant change in parent perceptions of self-
stimulating behaviors or social skills following the ProFoveate™ intervention. The alternative hypothesis 
predicts that the ProFoveate™ intervention will have a significant effect on parent perceptions of self-
stimulating behaviors and social skills behaviors. Regarding the electrophysiological measure (ERP) of 
change in neural activation, the null hypothesis states that following ProFoveate™ intervention, there 
will be no measurable change in ERP measures during an accepted cognitive task.  The alternative 
hypothesis states that there will be a measurable difference in neural activation as demonstrated by 
changes in P50 and P300 peak and latency measures in the ASD group receiving ProFoveate™ 
intervention.  
 
Inclusion/Exclusion Criteria 

TITLE:  The Effects of ProFoveate TM on Reducing Self- Stimulating Behaviors In Children Diagnosed With Autism Spectrum Disorders. 
PI: Atcherson, S. 
Co-I: Gentry, B. 
Version 4, 9.8.14 
 
 
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A total of 30 parents and their children with ASD between the ages of 10-17 years will be recruited for 
this study.  Participants who return consent and assent forms, must meet the following criteria to be 
included in the study: 
 
Inclusion Criteria   
 Have a documented diagnosis of high functioning autism spectrum disorders (autism, Asperger’s 
syndrome, or PDD-NOS) as reported by specialists who use the established criteria (American 
Psychiatric Association,2000)  
 Pass a hearing screening at 25 decibels for the frequencies 1000, 2000 and 4000 hertz 
 Score 85 or above on the Test of Nonverbal Intelligence- 4 (TONI-4; Brown, Sherbenou & 
Johnsen, 2009) 
 Exhibit noticeable self- stimulating or ritualistic behaviors (i.e., scratching, hand flapping, eye 
blinks, etc.) and/or visual characteristics of ASD (sensitivity to light, visual fixations, poor eye 
contact, etc.) as reported by parents and/or observed on videos taken during assessment. 
 
Exclusion Criteria 
 Known history of latex allergy 
 Score 84 or below on the Test of Nonverbal Intelligence- 4 (TONI-4; Brown, Sherbenou & 
Johnsen, 2009) 
 Fail the hearing screening 
 
Ethical Considerations 
The following disclosure statement will be included on consent forms: “Dr. Betholyn Gentry is entitled to 
royalties derived from the sale of ProFoveate™ products related to this research study.  This research 
study could affect this financial interest.  This means that the amount of royalties could increase or 
decrease based on the results of this study.   The terms of this arrangement have been reviewed and 
approved by the UAMS Conflict of Interest Committee in accordance with UAMS Conflict of Interest 
Policies. The researchers will abide by the management plan outlined by the Conflict of Interest 
Committee (see attached management plan).” 
 
This study will be conducted in accordance with all applicable government regulations and University of 
Arkansas for Medical Sciences research policies and procedures.  This protocol and any amendments will 
be submitted and approved by the UAMS Institutional Review Board (IRB). 
 
The formal written consent/assent of each parent/child dyad will be obtained before any study 
procedure is performed.  Parent and child participants will be provided a consent or assent form 
describing this study and providing sufficient information in language suitable for participants to make 
an informed decision about their participation in this study.  The person obtaining consent/assent will 
thoroughly explain each element of the document and outline the risks and benefits, alternate 
treatment(s), and requirements of the study.  The consent/assent process will take place in a quiet and 
private room, and participants may take as much time as needed to make a decision about their 
participation.  Privacy will be maintained and questions regarding participation will be answered.  No 
coercion or undue influence will be used in the consent/assent process.  The consent form must be 
signed by the parent participant and the individual obtaining the consent.  The assent form must be 
signed by the child participant.  A copy of the signed consent and assent forms will be given to the 
parent participant, and the informed consent/assent process will be documented in each subject’s 
research record (See Informed Consent Process Note). 
 

TITLE:  The Effects of ProFoveate TM on Reducing Self- Stimulating Behaviors In Children Diagnosed With Autism Spectrum Disorders. 
PI: Atcherson, S. 
Co-I: Gentry, B. 
Version 4, 9.8.14 
 
 
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Risks and Benefits 
 
Risks Associated with ProFoveateTM 
Risks include the fact that the adhesives used to hold on the pellets contain trace amounts of latex.  If 
the pellet causes the development of an abrasion, the skin should be allowed to rest 24 hours after 
which the pellet should be positioned at alternate positions such as shen men or point zero or P6 WRIST 
position. If the pellets are ingested, drink plenty of fluids and the pellets will be expelled from the body 
naturally. 
 
Risks Associated with ERP Recordings 
Risks associated with ERP recordings are minimal and pose no greater risk to individuals than would 
occur in daily life. All electronic instrumentation is appropriately grounded, all auditory stimuli are 
calibrated to safe auditory presentation levels, and all metal surface electrodes are cold sterilized. In the 
PI’s clinical experience, only 1 patient in the 6 years the lab has been in existence experienced a small 
rash related to a reaction from the medical grade tape we use to secure the electrodes to the face. No 
other adverse reactions have been reported to any other products we use to prepare the skin surface 
for the electrodes, and the securing of electrodes to the head. Having to wear electrodes with wires 
hanging off the head may be disconcerting to some, but we have never experienced early termination of 
an ERP test because of electrode-related discomfort. Finally, having to sit and actively attend to the 
visual or auditory stimuli may be uncomfortable to some, but we have never experienced early 
termination of an ERP test because of discomfort related to our standard procedures. 
 
Other Study Risks 
It is possible that a breach of subjects’ confidential information could occur.  Measures will be 
implemented to minimize this risk as described in the Data Handling and Recordkeeping section below. 
 
Potential Benefits 
The potential benefits to science and humanity that may result from this study include the possibility of 
finding a treatment procedure for reducing self-stimulating behaviors in children with ASD.  This study 
will provide information to researchers and professionals working with children diagnosed with high 
functioning autism to help them manage self-stimulating behaviors in this population. 
 
Safety Assessments 
Eliciting and Reporting Adverse Events:  Subjects will be assessed for the occurrence of adverse events at 
each study visit.  All adverse events occurring during the course of the study will be recorded on the 
Adverse Event Case Report Form and reported in accordance with the applicable regulations. 
 
Identification of Adverse Events:  An adverse event is defined as any new medical problem, or 
exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or 
not it is considered device-related by the investigator. 
Relationship of Adverse Events to the investigational Device:  The study physician will assess the 
relationship of the adverse event to the investigational device.  The relationship will be assessed using 
the following categories: 
 
Definitely Related: A direct cause and effect relationship between the investigational device and 
the adverse event exists.  
 
Possibly Related: A direct cause and effect relationship between the investigational device and 
the adverse event has not been clearly demonstrated, but is likely or very likely.  

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PI: Atcherson, S. 
Co-I: Gentry, B. 
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 
Unlikely Related: A direct cause and effect relationship between the investigational device and 
the adverse event is improbable, but not impossible.  
 
Unrelated: The adverse event is definitely not associated with the investigational device. 
 
Serious Adverse Events:  Each adverse event will be assessed for its seriousness using the criteria 
outlined below.  The term serious adverse event is not synonymous with a “severe” adverse event, 
which may be used to describe the intensity of an event experience by the subject.  An adverse event 
will be classified as serious if it meets any of the following criteria: 
 
Results in, or contributes to, a death; 
 
Life-threatening (i.e., the subject was, in the opinion of the investigator, at risk of death at the 
time of the event, but it does not include an event that, had it occurred in a more severe form, 
might have caused death); 
 
Results in permanent disability or incapacity (i.e., permanent impairment of a body function or 
permanent damage to a body structure); 
 
Requires in-patient hospitalization or prolongs hospitalization; 
 
Necessitates medical or surgical intervention to preclude a permanent disability or incapacity; 
 
Results in a congenital anomaly or birth defect. 
Non-serious adverse events are all events that do not meet the criteria for a “serious” adverse event. 
 
Severity:  Each adverse event will be assessed for its severity, or the intensity of an event experienced by 
the subject using the following: 
 
Mild:  Discomfort noticed, but no disruption to daily activity. 
 
Moderate:  Discomfort sufficient to reduce or affect normal daily activity. 
 
Severe:  Inability to work or perform normal daily activity. 
 
Deaths:  The investigator will notify the Sponsor as soon as possible, preferably within 24 hours but in no 
event later than 48 hours, of learning of a subject’s death, regardless of whether the death is related or 
unrelated to the investigational drug.  The investigator will attempt to determine, as conclusively as 
possible, whether the death is related to the device.  The cause of death and the investigator’s 
discussion regarding whether or not the death was device-related will be described in a written report. 
 
Pre-existing Conditions:  Pre-existing conditions will not be reported as an adverse event unless there 
has been a substantial increase in the severity or frequency of the problem which has not been 
attributed to natural history. 
 
Unanticipated Adverse Device Effects:  An unanticipated adverse device effect is defined as any serious 
adverse effect on health or safety, or any life-threatening problem, or death caused by, or associated 
with, a device; if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan, or application (including supplementary application), or 
any other unanticipated serious problem associated with a device that relates to the rights, safety, or 
welfare of subjects. 
 
If an unanticipated adverse effect occurs, the investigator will promptly notify the sponsor of such an 
event within 24 hours of first learning of the event.  The investigator will notify the IRB of such an event 
as soon as possible, but no later than ten (10) working days after first learning of the event. 
 
Statistical Plan 

TITLE:  The Effects of ProFoveate TM on Reducing Self- Stimulating Behaviors In Children Diagnosed With Autism Spectrum Disorders. 
PI: Atcherson, S. 
Co-I: Gentry, B. 
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To determine significance in the occurrence of self-stimulating behaviors or social skills following 
ProFoveate™ intervention nonparametric statistics will be run on questionnaire and test data obtained 
from the experimental and control groups.  Test data will consist of pre and post treatment standard 
scores obtained from the test manuals and questionnaire data will consist of pre and post treatment 
summative Likert scores reported by parents.  In order to gather ERP data, use of the STIM2 software, 
SCAN EEG analysis software and associated hardware/peripheral devices (located in the Auditory 
Electrophysiological (Re)Habilitation Lab of the PI) for data gathering and analysis of the P300 ERP will 
be utilized  for each participant.   There are two independent variables: control group and experimental 
group. There are seven dependent variables: SSIS parent scores, SSIS student scores, TOPL-2 scores, 
blinded P50 measures, blinded P300 measures, Parent Questionnaire scores and blinded video ratings of 
self-stimulating behaviors (see supporting materials). Interjudge reliability for video ratings will be 
established by having two observers review 25% (8) of the video recordings, document the occurrence 
of self-stimulating behaviors and calculating the percent agreement. These scores will be triangulated to 
compensate for the fact that the parent ratings are not blinded.  The data will be analyzed using a 2 
(group) x 3 (standardized scores) x 1 (Physiological measure) x 2 (observational measures) repeated 
measures multivariate analysis of variance (See Figure 5).    
 
Data Handling and Recordkeeping 
All questionnaires and test forms will be maintained by the principal investigator in a locked file 
accessible only to the staff of the research study for three years. Both assessment sessions with students 
will be video recorded for later analysis of observable self- stimulating behaviors.  Only the co-
investigator and Citi-certified graduate students will view the videotapes.  The videotapes and 
assessment protocols will be maintained in a locked file in the co-investigator's lab for three years and 
then destroyed. 
 
Confidentiality 
No participants will be identified in any reports except by a study identification number.  Participants 
will be assigned a number (1 - 15) and a group (control or experimental) randomly. All computerized 
files will be stored on password protected computers. No computerized data files will include names, 
addresses or phone numbers.  No identifying information will be used in the study or future 
publications.   
 
Study Registration and Publication 
This study will be registered on the ClinicalTrials.gov website as required by law. The results of this study 
will be written as a manuscript and submitted for publication. The results will also be presented in 
abstract form at a state or regional or national speech language pathology conference by the PI and/or 
the Co-investigator. 
 
References 
Abel, L.A. , Wang, Z.I. & Dell'Osso, L.F. (2008). Wavelet analysis in infantile nystagmus syndrome:  
Limitations and abilities.  Investigative Ophthalmology & Visual Science, 49(8), 3413-3424. 
 
American Psychiatric Association. (2000). Diagnostic and Statistical Manual of Mental Disorders (4th ed. 
revised). Washington, DC. 
 
Andersson, S., Barder, H., Hellvin, T., Løvdahl, H., & Malt, U. (2008). Neuropsychological and 
electrophysiological indices of neurocognitive dysfunction in bipolar II disorder. Bipolar Disorders, 10(8), 
888-899. 

TITLE:  The Effects of ProFoveate TM on Reducing Self- Stimulating Behaviors In Children Diagnosed With Autism Spectrum Disorders. 
PI: Atcherson, S. 
Co-I: Gentry, B. 
Version 4, 9.8.14 
 
 
13 
 
 
Balaz, M., Rektor, I., & Pulkrabek, J. (2008). Participation of the subthalamic nucleus in executive 
functions: An intracerebral recording study. Movement Disorders, 23(4), 553-557. 
Boyd, B.A., Baranek, G.T., Sideris, J., Poe, M.D., Watson, L.R., Patten, E., & Miller, H. (2010). Sensory 
features and repetitive behaviors in children with autism and developmental delays. Autism Research, 
3(2), 78-87. DOI: 10.1002/aur.124 
Brown, L., Sherbenou, R.J., & Johnsen, S.K. (2010). Test of Nonverbal Intelligence- 4 (TONI-4). PRO-ED, 
Austin, TX. 
 
Centers for Disease Control and Prevention (2013). Prevalence of autism spectrum disorders. 
Surveillance Summaries, MMWR, 58(No. SS-10). Retrieved from http://www.cdc.gov 
 
Constantino, J. N., Davis, S. A., Todd, R. D., Schindler,M. K., Gross, M. M., Brophy, S. L., et al. (2003). 
Validation of a brief quantitative measure of autistic traits: Comparison of the Social Responsiveness 
Scale with the Autism Diagnostic Interview—Revised. Journal of Autism and Developmental Disorders, 
33, 427–433. 
 
Dichter, G., Felder, J., & Bodfish, J. (2009). Autism is characterized by dorsal anterior cingulate 
hyperactivation during social target detection. Social Cognitive and Affective Neuroscience, 4(3), 215-
226. 
 
Dichter, G., van der Stelt, O., Boch, J., & Belger, A. (2006). Relations among intelligence, executive 
function, and P300 event related potentials in schizophrenia. Journal of Nervous and Mental Disease, 
194(3), 179-187. 
 
Dymond, Gilson & Myran (2007).  Services for children with autism spectrum disorders.  Journal of 
Disability Policy Studies, 18(3),  133-147. 
 
Edelson, S.M., Arin, D., Bauman, M., Lukas, S.E., Rudy, J.H., Sholar, M., &  Rimland, B. (1999). Auditory 
integration training: a double-blind study of behavioral and electrophysiological effects in people with 
autism. Focus on Autism and Other Developmental Disabilities, 14, 73-81. 
 
Epp, K. M. (2008). Outcome-based evaluation of a social skills program using art therapy and group 
therapy for children on the Autism Spectrum. Children &Schools, 30, 27-36.   
 
Feinberg, E., & Beyer, J. (1998). Creating public policy in a climate of clinical indeterminancy: Lovaas as 
the case example du jour.  Infants and Young Children, 10(3), 54–66. 
 
Feinberg, E., & Vacca, J. (2000). The drama and trauma of creating policies on autism: Critical issues to 
consider in the new millennium. Focus on Autism and Other Developmental Disabilities, 15, 130–137. 
 
Fong, L.,Wilgosh, L., & Sobsey,D. (1993).The experience of parenting an adolescent with autism. 
International Journal of Disability, 40, 105–113. 

TITLE:  The Effects of ProFoveate TM on Reducing Self- Stimulating Behaviors In Children Diagnosed With Autism Spectrum Disorders. 
PI: Atcherson, S. 
Co-I: Gentry, B. 
Version 4, 9.8.14 
 
 
14 
 
Fertel-Daly, D., Bedell, G. & Hinojosa, J. (2001). Effects of a weighted vest on attention to task and self-
stimulatory behaviors in preschoolers with pervasive developmental disorders. American Journal of 
Occupational Therapy, 55(6), 629-640.  DOI: 10.5014/ajot.55.6.629 
Fombonne, E. (2005). The changing epidemiology of autism. The Journal of Applied Research in 
Intellectual Disabilities, 18, 281-294. 
 
Gelbart,  S.S. & Hoyt, C.S. (1988).  Congenital nystagmus: a clinical perspective in infancy. Graefe's 
Archive for Clinical and Experimental Ophthalmology, 226, 178–80. 
 
Gentry, B.F. (2012).  Questionnaire for Parents of Children with Autism Spectrum Disorders. 
 
Glascoe, F. P. (1997). Parents’ concerns about children’s development: prescreening technique or 
screening test?  Pediatrics, 99, 522-528. 
 
Glascoe, F. P., Altemeier, W. A., & MacLean, W. E. (1989). The importance of parents’ concerns about 
their  child’s development. American Journal of Diseases of Children, 143, 955-958. 
 
Glascoe, F. P., & Dworkin, P. H. (1995).  The role of parents in the detection of developmental and 
behavioral problems.  Pediatrics, 95, 829-836. 
 
Glascoe, F. P., MacLean, W. E., & Stone, W. L. (1991). The importance of parents’ concerns about their 
child’s  behavior.  Clinical Pediatrics, 30, 8-11. 
 
Grandin, T. (1996).  Brief Report:  Response to National Institute of Heaqlth Report.  Journal of Autism 
and Developmental Disorders, 26, 185-187. 
Gresham, F. M., & Elliot, S. N. (2008). Social Skills Improvement System (SSIS). Pearson: Minneapolis, NN. 
 Harris ,L.S. & Wolchik. S.A. (1979).  Suppression of self-stimulating: three alternative strategies.  Journal 
of Applied Behavior Analysis. 12, 185-198. 
 
Happe, F. & Frith, U. (1996). Invited Review: The neuropsychology of autism. Brain, 119, 1377-1400. 
 
Jongen, E., & Jonkman, L. (2011). Effects of concurrent working memory load on distractor and conflict 
processing in a name‐face Stroop task. Psychophysiology, 48(1), 31-43. 
 
Kennedy, C.H., Meyer, K.A., Knowles, T., Smita, S. (2000). Analyzing the multiple functions of 
stereotypical behavior for students with autism: Implications for assessment and treatment. Journal of 
Applied Behavior Analysis, 33, 559-571. 
 
Kim, M., Kim, J., & Kwon, J. (2001). Frontal P300 decrement and executive dysfunction in adolescents 
with conduct problems. Child Psychiatry and Human Development, 32(2), 93-106. 
 
Knott, V., Millar, A., Dulude, L., Bradford, L., Alwahhabi, F., Lau, T., Shea, C., et al. (2004). Event-related 
potentials in young and elderly adults during a visual spatial working memory task. Clinical EEG And 
Neuroscience: Official Journal Of The EEG And Clinical Neuroscience Society (ENCS), 35(4), 185-192. 
 

TITLE:  The Effects of ProFoveate TM on Reducing Self- Stimulating Behaviors In Children Diagnosed With Autism Spectrum Disorders. 
PI: Atcherson, S. 
Co-I: Gentry, B. 
Version 4, 9.8.14 
 
 
15 
 
Kohler, F.W. (1999). Examining the services received by young children with autism and their families: A 
survey of parent responses. Focus on Autismand Other Developmental Disabilities, 14, 150–158. 
 
Laugeson, E. A., Frankel, F., Mogil, C., & Dillon, A. R. (2009). Parent-assisted social skills training to 
improve friendships in teens with Autism Spectrum Disorders.  Journal of Autism and Developmental 
Disorders, 39, 596–606. 
 
Liber, D. B., Frea, W. D., & Symon, J. B. G. (2008). Using time-delay to improve social play skills with 
peers for children with autism. Journal of Developmental & Physical Disabilities, 38, 312–323. 
 
Little, L. (2003). Maternal perceptions of the importance of needs and resources for children with 
Asperger syndrome and nonverbal learning disorders.  Focus on Autism and Other Developmental 
Disabilities, 18, 257-266. 
 
Macintosh, K. & Dissanayake, C. (2006).  Social skills and problem behaviours in school aged children 
with high-functioning autism and Asperger’s Disorder. Journal of Autism and Developmental Disorders, 
37, 1065–1076. 
 
Matson, J.L., Dempsey, T., Fodstand, J.C. (2009) Stereotypies and repetitive/Restrictive behaviors in 
children with autism and Pervasive Developmental  Disorder. Developmental Neurorehabilitation, 122- 
27. 
 
Matson, J.L., LoVullo, S. (2010). Automatic prompting and positive attention to reduce tongue protrusion 
and head tilting by two adults with severe to profound intellectual disabilities.  Behavior Modification, 
34, 299-309.  
 
Maekawa, T., Tobimatsu, S., Inada, N., Oribe, N., Onitsuka, T., Kanba, S., & Kamio, Y. (2011). Top-down 
and bottom-up visual information processing of non-social stimuli in high-functioning autism spectrum 
disorder. Research in Autism Spectrum Disorders, 5(1), 201-209. 
Militerni, R., Bravaccio, C., Falco, C., Fico, C., & Palermo, M.T. (2002).  Repetitive behaviors in autistic 
disorder.  European Child and Adolescent Psychiatry, 11(5), 210-218. 
Miller, L.J., Reisman, J., McIntosh, D.N., & Simon, J. (2001). The ecological model of sensory modulation: 
Performance of children with Fragile X Syndrome, Autism, ADHD and SMD.  In S. Roley, R. Schaaf, & E. 
Blanche (Eds.) Sensory integration and developmental disabilities.  San Antonio, TX: Therapy Skill 
Builders 
 
Murray, D. S., Ruble, L. A., Willis, H., & Molloy, C. A. (2009). Parent and teacher report of social skills in 
children With Autism Spectrum Disorders. Language, Speech, and Hearing Services in Schools, 40, 109–
115. 
 
Nelson D, Nitzberg, L. & Hallander, T. (1980).  Visually monitored postrotary nystagmus in seven autistic 
children.   The American Journal of Occupational Therapy, 34(6), 382-386. 
 
Newschaffer, C., Falb, M., & Gurney, J. (2005). National autism prevalence trends from United States 
special education data. Pediatrics, 115, 277-282. 
 

TITLE:  The Effects of ProFoveate TM on Reducing Self- Stimulating Behaviors In Children Diagnosed With Autism Spectrum Disorders. 
PI: Atcherson, S. 
Co-I: Gentry, B. 
Version 4, 9.8.14 
 
 
16 
 
Norusis, M. (2008).  SPSS 16.0 Guide to Data Analysis (2nd Edition).  Prentice Hall Press, Upper Saddle 
River, NJ. 
 
Ornitz, E.M., Atwell, C.W., Kaplan, A.R., & Westlake, J.R. (1985). Brain-stem dysfunction in autism; 
results of vestibular stimulation.  Archives of General Psychiatry, 31, 369–375. 
 
Ornitz, E.M., Guthrie, P., & Farley, A.H. (1977). The early development of autistic children.  Journal of 
Autism and Childhood Schizophrenia, 7, 207–229. 
 
Ornitz, E.M., Brown, M.B., Mason, A., & Putnam, N.H. (1974).  Effect of visual input on vestibular 
nystagmus in autistic children. Archives of General Psychiatry, 31, 369–375. 
 
Paul, R., Richard, C., Lawrence, J., Goldberg, E., Williams, L., Cooper, N., Cohen, R., et al. (2005). Age-
dependent change in executive function and gamma 40 hz phase synchrony. Journal of Integrative 
Neuroscience, 4(1), 63-76. doi:Article 
 
Perry, W., Minassian, A., Lopex, B., Lincoln, A. (2007). Sensorimotor Gating Deficits in Adults with 
Autism. Society of Biological Psychiatry, 61: 482-496. 
 
Phelps-Terasaki, D. & Phelps-Gunn,T. (2007). Test of Pragmatic Language – 2. Western Psychological 
Services: Torrence, CA. 
 
Picton, T., Bentin, S., Berg, P., Donchin, E., Hillyard, A., Johnson, R., Miller, G., et al. (2000).  Guidelines 
for using human event-related potentials to study cognition:  Recording standards and publication 
criteria. Psychophysiology, 37, 127-152. 
 
Prout, T. (2005). Auditory and visual P300 event related potentials: Latency differences and modality 
dependence. Dissertation, The University of Memphis. 
 
Ray, T.C., King, L.J., & Grandin, T. (1988).  The effectiveness of self initiated vestibular stimulation in 
producing speech sounds in an autistic child.  Journal of Occupational Therapy Research, 8, 186-190 
Rice, C. (2009).  Prevalence of Autism Spectrum Disorders ---Autism and Developmental Disabilities 
Monitoring Network, United States, 2006. Surveillance Summaries, 58, 1-20. 
 
Rosenfield, J.P. & Skogsberg, K.R. (2006). P300-based Stroop study with low probability and targey 
Stroop oddballs: the evidence still favors the response selection hypothesis. International Journal of 
Psychophysiology, 60, 240-250. 
 
Rosental-Malek, A. & Mitchell, S. (1997). Brief Report: The effects of exercise on the self-stimulatory 
behaviors and positive responding of adolescents with autism. Journal of Autism and Developmental 
Disorders, 27 (2), 193-202. 
 
Roth, R. (2000). Executive functions in obsessive-compulsive disorder: A neuropsychological and event-
related 
potential 
investigation. 
ProQuest 
Information 
& 
Learning, 
US. 
Retrieved 
from 
http://libproxy.uams.edu/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=psyh&AN=
2000-95018-216&site=ehost-live&scope=site 
 

TITLE:  The Effects of ProFoveate TM on Reducing Self- Stimulating Behaviors In Children Diagnosed With Autism Spectrum Disorders. 
PI: Atcherson, S. 
Co-I: Gentry, B. 
Version 4, 9.8.14 
 
 
17 
 
Roussi, M., Dalens, H., Marcellier, J.J. & Bacin, F. (2011). Congenital nystagmus and negative 
electroretinography. Clincial Ophthalmology, 5, 429-34. 
 
Sachs, G., Anderer, P., Margreiter, N., Semlitsch, H., Saletu, B., & Katschnig, H. (2004). P300 event-
related potentials and cognitive function in social phobia. Psychiatry Research, 131(3), 249-261. 
 
Smith, Press, Koenig, and Kinnealey (2005). The effects of sensory integration on self-stimulation and 
self-injurious behaviors.  The American Journal of Occupational Therapy, 459, 18-425. 
 
Spann, S. J., Kohler, F.W., & Soenksen, D. (2003). Examining parents’ involvement in and perceptions of 
special education services: An interview with families in a parent support group. Focus on Autism and 
Other Developmental Disabilities, 18, 228–237. 
 
Sperry, L. A.,Whaley, K. T., Shaw, E., & Brame, K. (1999). Services for young children with autism 
spectrum disorder:Voices of parents and providers.  Infants and Young Children, 11(4), 17–33. 
 
Starr, E. M., Foy, J. B., & Cramer, K. M. (2001). Parental perceptions of the education of children with 
Pervasive Developmental Disorders. Education and Training in Mental Retardation and Developmental 
Disabilities, 36, 55-68. 
 
Sumich, A., Kumari, V., Dodd, P., Ettinger, U., Hughes, C., Zachariah, E., & Sharma, T. (2008). N100 and 
P300 amplitude to Go and No-Go variants of the auditory oddball in siblings discordant for 
schizophrenia. Schizophrenia Research, 98(1-3), 265-277. 
 
Sutherland, A. & Crewther, D.P. (2010). Magnecellular visual evoked potential delay with high autism 
spectrum quotient yields a neural mechanism for altered perception.  Brian, 133, 2089-2097.  
 
Tse, J., Strulovitch, J., Tagalakis, V., Meng, L., &  Fombonne, E. (2007). Social skills training for 
adolescents with Asperger Syndrome and high-functioning Autism. Journal of Autism and Developmental 
Disorders, 37, 1960–1968.  
Turner, M. (2003).  Annotation:  Repetitive behaviour in autism: A review of psychological research. 
Journal of Child Psychology and Psychiatry, 40(6), 839-849. DOI: 10.1111/1469-7610.00502 
Watters, R.G. & Watters, W.E. (1980).  Decreasing self-stimulatory behavior with physical exercise in a 
group of autistic boys. Journal of Autism and Developmental Disorders, 10 (4), 379-387. 
Whitaker, P. (2002). Supporting families of preschool children with autism: What parents want and what 
helps. Autism, 6, 411–426. 
Wing, L., & Potter, D. (2002). The epidemiology of autistic spectrum disorders: is the prevalence rising?  
Mental Retardation and Developmental Disabilities Research Reviews, 8, 151-161.