Transcranial Photobiomodulation for Reducing Autism Symptoms in Children
Phase: NA
Conditions: Autism Spectrum Disorder
Sponsor: JelikaLite LLC

 
 
 
Transcranial Photobiomodulation for 
reducing autism symptoms in 
children. 
 
 
 
October 1, 2020 

 
Page 1 of 19 
 
PROTOCOL TITLE: 
 
Transcranial photobiomodulation for reducing autism symptoms in children.  
 
PRINCIPAL INVESTIGATOR: 
Name  
 
 
 Yuli Fradkin, MD 
Department 
 
 
N/A 
Phone Number 
 
 
CO-INVESTIGATORS: 
Name  
 
 
Eugenia Steingold, Ph.D 
Department 
 
 
N/A 
Phone Number 
 
347-779-2473 
 
 
Name  
 
Katya Sverdlov, CFA, Esq. 
Department 
 
 
N/A 
Phone Number 
 
917-671-0601 
 
 
1.0 
Purpose of the study: 
 
The purpose of this 8-week  open label feasibility study is to assess the tolerability, safety and efficacy 
of Transcranial LED Therapy for language learning and reducing symptoms of autism in children.   
 
The investigators propose to enroll up to 30 participants of both genders ages 24 months to 6 years who 
have been previously diagnosed with moderate to severe ASD by licensed professionals according to the 
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Autism 
Spectrum Disorder (ASD).  
 
The hypothesis to be tested is that exposure to photobiomodulation and speech parsing program will 
reduce children’s symptoms of autism, such as delays in language production and comprehension, 
anxiety, tantrums, limited eye-contact and improve responsiveness. 
 
 
2.0 
Background / Literature Review / Rationale for the study: 
 
2.1 Background Science of Photobiomodulation and Rationale:  
 
There are several studies that suggest that mitochondrial energy disturbance is an underlying 
mechanism of autism, for at least some of the children.  Specifically, Weisman, Kelley, Bauman, Cohen, 
Murray, Mitchell and Kern (2008) looked at the medical records of 25 children diagnosed with autism 
and found that “Levels of blood lactate, plasma alanine, and serum ALT and/or AST were increased at 
least once in 76%, 36%, and 52% of patients, respectively”. Furthermore, 2 out of those 25 people had 
rare mtDNA mutations. The authors concluded that at least for a subset of ASD children, mitochondrial 
disturbances in energy production could be the underlying mechanism.  Furthermore, Giulilvi, Zhang, 
Omanska-Klusek, Ross-Intra, Hertz-Picciotto, Tasson and Pessach (2010), looked at biochemical 
markers of ASD kids (2-5yo), and concluded that ASD children are more likely to have Mitochondria 
dysfunction, mtDNA replication and mtDNA deletion than neurotypical ones.   

 
Page 2 of 19 
 
In addition, Siddiqui, Elwell and Johnson (2016) conducted meta-analyses of the studies 
reporting decreased activity of mitochondrial electron transport chain (ETC) complexes and reduced 
gene expression of mitochondrial genes, in particular genes of respiratory chain complexes, in 
individuals with autism (not necessarily children). They concluded that current research supports the 
link between ASD and mitochondrial dysfunction. However, they also conceded that in many studies 
that they reviewed the sample size was small and argued for further research including near infrared 
spectroscopy to provide more precise information of Mitochondria dysfunction in ASD individuals. 
Based on these and other studies, it is reasonable to conclude that there is evidence linking ASD with 
mitochondria dysfunction (specifically difficulties with energy producing) in at least some ASD 
individuals.  
Transcranial photobiomodulation (tPBM) could be the solution to Mitochondrial Disturbances in 
ASD individuals (resulting in functional  brain connectivity):  Michael Hamblin (2016) argued that 
Transcranial Photobiomodulation (“tPBM") could be helpful in addressing various neurological 
disorders (including ASD) because Nitric Oxide could be dissociated by photons of light. When Nitric 
Oxide is dissociated, the mitochondrial membrane potential is increased, more oxygen is consumed, 
more glucose is metabolized and more Adenosine Triphosphate (ATP) is produced by the mitochondria. 
In another paper, Dr. Hamblin discusses research on the effect of light stimulation on mitochondria, 
specifically he discusses in vitro studies with isolated mitochondria (isolated rat livers), where increased 
ATP synthesis was detected. Furthermore, tPBM has been found to be effective in treating several 
neurological conditions and disorders, including Stroke (Naeser and Hamblin, 2011), Traumatic Brain 
Injury (Naeser and Hamblin, 2015; Naeser et al, 2016) and Alzheimer’s Disease (Johnston et al, 2015).   
 
There is preliminary data that transcranial photobiomodulation reduces symptoms of autism (e.g. 
improvement of speech, improvement of responsiveness, reduction of tantrums, and abberant behaviors, 
improvement of sleep, and improvement of eye contact), Leisman et al 2018.  Photobiomodulation has 
also been found to be effective for treatment of other neurological conditions without any side effects.  
Conditions include Alzheimer’s, depression, TBI and stroke, Cassano et al 2016, Hamblin 2016, Naeser 
et al 2011, Naeser 2010.  
Leisman et al (2018) administered tPBM to children (5-18 years old) diagnosed with autism and 
found significant reduction in symptoms (after only 2 months of applications, two sessions a week). 
Leisman et al stimulated brain’s temporal lobe (to reach Broca and Wernike areas) as well as occipital 
lobe. Leisman et al (2018) specifically argued that administration of tPBM increases brain connectivity. 
Leisman et al used ERCHONIA laser for their study (please see attached spreadsheet, comparing our 
device’s specifications to those of Erchnoia). Currently, there is a an ongoing clinical study at Mass 
General hospital (Tolga A Ceranoglu,PI;  NCT03724552) which tests tPBM on adult individuals with 
ASD (older than 18).  During personal communication with one of the experimenters (Dr. Paolo 
Cassano), it was revealed that they found statistically significant improvement in brain connectivity and 
reduction of symptoms. In addition, tPBM is currently being used in clinical studies for other 
neurological disorders such as Down syndrome and Sleep Bruxism.    
Overall, many researchers seem to agree that ASD could be a result of Mitochondrial 
disturbances, which leads to brain disconnectedness and tPBM could be beneficial for increasing ATP, 
promoting brain connectivity and reducing symptoms of ASD.  Overall, tPBM has been shown to 
increase blood flow to brain as well as increase its oxidative metabolism resulting in increased brain 
activation and decreased inflammation.  Dmochowky J & Dmoshowsky P (2018) demonstrated this 
process by applying tPBM to humans while simultaneously scanning brains with fMRI.   
In summary, the way photobiomodulation works is as follows: the mitochondria in brain cells 
absorbs the light and produces more ATP (energy molecules). Having more ATP enables the brain to 
have more energy, form new neural connections, and reduce inflammation.  In addition to ASD, tPBM is 
being used for various neurological and psychiatric conditions including dementia, depression, tbi and 
stroke (the same mechanism is beneficial for alleviating all those conditions).Therefore, children who 

 
Page 3 of 19 
 
will be exposed to the photobiomodulation treatment may experience reduction of autism symptoms, 
which will improve their lifelong outcomes. Previous studies of photobiomodulation (using either LED 
or lasers) have found no side effects.   
 
 
 
 
2.41Publications:  
 
Published research on the benefit of photobiomodulation in neurological conditions:  
• Cassano P., Petrie S.R., Hamblin M.R., Henderson T.A., Iosifescu D.V. Review of transcranial 
photobiomodulation for major depressive disorder: targeting brain metabolism, inflammation, 
oxidative stress, and neurogenesis. Neurophotonics. 2016;3:031404. 
• Hamblin, M. R. (2016). Shining Light on the Head. BBA Clinical, 6, 113-124 
• Leisman, Machado, Machado (2018) Effects of Low-Level Laser Therapy in Autism Spectrum 
Disorder. Clinical Medicine Research, 111-130. 
• Naeser M.A., Saltmarche A., Krengel M.H., Hamblin M.R., Knight J.A. Improved cognitive 
function after transcranial, light-emitting diode treatments in chronic, traumatic brain injury: two 
case reports. Photomed. Laser Surg. 2011;29:351–358. 
• Naeser M.A., Martin P.I., Lundgren K., Klein R., Kaplan J., Treglia E., Ho M., Nicholas M., 
Alonso M., Pascual-Leone A. Improved language in a chronic nonfluent aphasia patient after 
treatment with CPAP and TMS. Cogn. Behav. Neurol. 2010;23:29–38. 
• Saltmarche A.E., Naeser M.A., Ho K.F., Hamblin M.R., Lim L. Alzheimer's Association 
International Conference, Toronto, Canada. 2016. Significant Improvement in Cognition after 
Transcranial and Intranasal Photobiomodulation: A Controlled, Single-Blind Pilot Study in 
Participants with Dementia 
 
 
 
2.2 Background of the Physical Device:  
We are developing a safe and effective protocol for administering tPBM via a wearable device. 
This physical device is getting developed by JelikaLite LLC. The parameters are developed by Dr. 
Eugenia Steingold (the PI of this study), Dr. Michael Hamblin (leading photobiomodulation expert from 
Harvard Medical School and an advisor to JelikaLite), Dr. Margaret Naeser (leading neuroscientist who 
is studying photobiomodulation at Boston Medical University and an advisor to JelikaLite), and David 
Conroy (an industrial product designer with over 30 years of expertise in designing medical devices).  
The purpose of this feasibility study is to evaluate the safety and comfort of the product, as well as 
preliminary efficacy of the treatment effect. The device will stimulate Default Mode Network (to 
increase brain connectiveness) as well as Broca and Wernike areas (to facilitate speech comprehension 
and production) and Occipital lobe (as many ASD children rely on visual information for language 
learning). The device will be physically light, comfortable to wear for children and could eventually be 
used at home as frequently as necessary. 
The reason why the device may be helpful to children is because of the science of 
photobiomodulation. The device will have embedded LED lights in it, which will shine red light and 
near infra red lights. The children will wear the device for approximately 5-10 minutes, twice a week 
(closely replicating the protocol of Leisman et al as well as the clinical study at MGH). The light 
stimulates mitochondrial ATP production.  Only about 2% of the light penetrates the skull. However, 
because brain is the largest energy consuming organ of the body, even those 2% result in significant 

 
Page 4 of 19 
 
improvement of the symptoms (even small boost in ATP production results in significant improvement).  
Having more energy enables the brain cells to heal, grow and form new neural connections. Other 
benefits of tPBM is increased blood flow to the brain, which increase brain oxygen supply and reduce 
inflammation.  
There have been two clinical studies done already that show that photobiomodulation reduces 
symptoms of autism. The major difference between our device and those used before is that we will be 
using LED instead of lasers and we will specifically target Default Mode Network (DMN) and language 
areas.  Massachusetts General Hospital study (quoted above) targeted DMN.  Leisman et all targeted 
broca and wernike areas and occipital lobe. We will target both DMN (to increase connectivity) and 
Language areas (broca and wernike) to facilitate language learning.   
Previous studies (Naeser et al) found that targeting DMN reduces symptoms of Alzheimer, TBI 
and Stroke.  Dr. Naeser also shared with us her tPBM language production protocol, which she used 
with her Stroke patient who also suffered from Aphasia.  Therefore, there are preliminary findings 
suggesting that using our protocol will be beneficial for children with autism, because it is expected to 
improve their language abilities and reduce other symptoms. Because our device uses LED lights instead 
of laser, it is light, wearable, easy to use by young children. We are specifically using soft, soothing 
materials, which will be comfortable even for children with sensory-integration difficulties (exhibited by 
many children with ASD). 
 
 
 
3.0 
Safety of the Device 
 
We are asking the Board to make a non-significant risk determination.  
 
The device is not approved or marketed.  
 
The device does not pose a risk to participants under 21 CFR 812.3(m). 
 
This investigational device is not:  
• Intended as an implant and presents a potential for serious risk to the health, safety or welfare of 
a participant; 
• Purported or represented to be for use supporting or sustaining human life and presents a 
potential for serious risk to the health, safety or welfare of a participant 
• For a use of substantial importance in diagnosing, curing, mitigating or treating disease or 
otherwise preventing impairment of human health and presents a potential for serious risk to the 
health, safety or welfare of a participant or 
• Otherwise presents a potential for serious risk to the health, safety or welfare of a participant.  
 
Please see Response to January 15 New England IRB Letter, specifically Responses to Questions 5 and 
6, for a full explanation of the device safety and comparison to other predicate devices.  .  
 
4.0 
Inclusion and Exclusion Criteria: 
 
Inclusion Criteria:  
1. Male or female participants between 2 years and 6 years of age (inclusive), of all races.   
2. Previously diagnosed with moderate or severe ASD by a licensed professional. 

 
Page 5 of 19 
 
3. Participants may be receiving any behavioral intervention therapy (e.g., ABA, Floor Time) 
during the course of the treatment. The final statistical analysis will control for the participants 
receiving behavioral therapies in control and experimental conditions. We expect the majority of 
the participants in both control and experimental conditions to be receiving behavioral therapies. 
There is no known interactions or complications of tPBM with behavioral therapy.  
 
4. Parents of participants must understand the nature of the study.  
5. Parents of participants must sign an IRB- approved informed consent form before initiation of any 
study procedures. 
6. Parents of participants must have a level of understanding sufficient to communicate with the 
investigator and study coordinator, and to cooperate with all tests and examinations required by the 
protocol.  
7.  Participant child experiencing a major psychiatric disorder will be allowed to participate in the study 
provided they do not meet any exclusionary criteria.  
8. The participant child is willing to participate in this study.      
 
Exclusion Criteria:  
1. Participant child is experiencing severe self-injurious behavior or severe aggressive behavior to self or 
others (within past 7 days).  
2. Participant has been diagnosed with another psychiatric or neurological disorder (e.g. epilepsy) or 
have exhibited symptoms of major psychiatric disorders within the last 30 days.  
3. Participant has an unstable medical condition (that requires clinical attention).  
4. Participant has a significant skin condition at the procedure sites (i.e., hemangioma, scleroderma, 
psoriasis, rash, open wound or tattoo).  
5. Participant has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, 
implantable shunt - Hakim valve). 
6. Participant has receiving medication on a regular basis for Autism or any other medical 
condition. 
7. Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment (in 
US: Visudine (verteporfin) - for age related macular degeneration; Aminolevulinic Acid- for actinic 
keratoses; Photofrin (porfimer sodium) - for esophageal cancer, non-small cell lung cancer; Levulan 
Kerastick (aminolevulinic acid HCl) - for actinic keratosis; 5-aminolevulinic acid (ALA)- for non-
melanoma skin cancer).  
8. Current treatment with a psychotropic medication.  
9. Investigator and his/her immediate family, defined as the investigator's child or grandchild.  
 
 
5.0 
Sample Size: 
 
30 children will be included in the study. We need at least 15 participants in the control condition, and 
15 participants will receive a combined light and audio treatment therapy. These numbers will allow us 
to gain sufficient statistical power to detect small size systematic effect. We anticipate to screen about 
40 participants to recruit 30 participants for the study.  
 
 
We plan to screen more than 30 prospective children, because we expect some of them to be ineligible 
for the study, due to the above listed Exclusion Criteria. We plan to enroll 30 children, so that each 
group will have at least 15 participants. We do anticipate that some of the participants  will withdraw, 
for various reasons. participant We will continue screening until we have 30 enrolled participants.  
 

 
Page 6 of 19 
 
If a participant drops out of the Study we will attempt to replace that participant, using the same 
Eligibility Screening Criteria.  
 
 
 
 
6.0 
Research Locations: 
 
1720 East 14th Street, Brooklyn NY 11229 
This is a private professional office, with a waiting room and a receptionist. There are several private 
rooms within the office.  
The child will led to a private room, which will have toys and books inside it. The caregiver and one of 
the researchers will be present in the room at all times.  
 
 
315 West 57th Street, Suite 401, New York, NY 10006 
This is a private professional office, with a waiting room and a receptionist. There are several private 
rooms within the office.  
The child will led to a private room, which will have toys and books inside it. The caregiver and one of 
the researchers will be present in the room at all times.  
 
 
7.0 
Procedures Involved: 
7.1 Location: The study will use pre-test and post-test design. The entire study on the children will 
be done in the office. The weekly interview with the parent may be done either in office or by 
phone, as preferred by the parent.  
 
7.2 Conditions: There are two  conditions: placebo condition,  and combined light and audio therapy 
treatment condition. The placebo control condition will listen to nursery rhymes. The placebo control 
condition will wear the same device, however the lights are not going to be turned on. Otherwise, 
all experience for participants in control and experimental conditions will be identical.  
                                   
 
This study replicates and extends previous studies of photobiomodulation in children older than 5 years 
of age (Leisman et al, 2018).   
 
7.3 Participants: The participants will be matched on age, gender and number of hours of therapy they 
receive independent from the study.   The participants will be 24-71 month old children previously 
diagnosed with moderate or severe ASD. The experiment will use random assignment. We plan to use 
30 participants (15in each group).   We plan to screen about 40 participants (or fewer) to recruit the 
30 participants for this study.                                                                                
 

 
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7.4 Random Assignment: Random assignment will be achieved by using random number generator 
programs frequently used in research (such as random.org). Each participant is assigned a number. The 
list of 30 numbers is entered into the program, which creates a random sequence of  30 participants. 
Here is an example of the beginning of such list generated for 30 participants 
 
1 – 23 
2 – 25 
1 – 12 
2 – 15 
1 – 21 
2 – 5 
1 – 19  
2 - 9 
Once the program generates the random sequence of 30 participants (in the example above, the sequence 
goes 23, 25, 12, 15, etc), we will simply alternate the assignment to treatment and control conditions.  
For example, in the example above, participant number 23 is assigned to the treatment condition (1), and 
participant number 25 is assigned to the control condition (2).  Because the sequence of the participants 
is randomized, the assignment to conditions is random.  
 
 
7.5 Treatment: The treatment will take place twice a week for up to 30 minutes at a time.  
During the study, while participants will be wearing the photobiomodulation device, they will be 
listening to the audio program, and they may be playing with their parent or the experimenter, using the 
toys of their choice (out of the many available in the experimenter’s office). The caregivers will be 
present during the experiment at all times. When the child and the parent arrive, they will be welcomed 
to the office, and introduced to the toys.  
 
The child will be encouraged to play with toys and interact with the parent (or the experimenter). The 
children in the experimental condition will be asked to wear the device for no longer than 15 minutes. 
The children in the controlled condition will play for 30 minutes and wear the same device, without 
turning it on (the device won’t be turned on at that time). The total time in the office will be about 30 
minutes (including playing).  
 

 
Page 8 of 19 
 
If the child becomes uncomfortable, the parents will be able to leave the experiment without any 
punishment. No coercion or deception is involved in this study.   
 
7.6 Pre and Post-Testing: CARS2 will be used for pretest and post-test. Please see attached a sample 
CARS 2 test.  CARS 2 scores will be compared for analyses. In addition, EEG will be collected from 
the participants in both Control and Experimental conditions pre and post -treatment (before 
Starting treatment in session 1 and in the end of treatment of Session 8). Mobile FDA approved 
EEG device Brain Scientific will be used to collect children’s pre and post test EEG. There is no 
known danger of EEG collecting. In this study it will be using for measuring the efficacy 
treatment only. 
 
7.7 On-going Data Collection: Parents will be asked to keep a daily diary of the child’s behavior, 
specifically – words spoken, comprehension of instructions, eye contact, his sleep pattern, number of 
tantrums, anxiety, social interaction and eating.  Qualitative data will be collected through short weekly 
interviews with the parents. These interviews can take place either in Dr. Steingold’s office during the 
child’s treatment or by phone. During those weekly interviews, the parents will be asked questions about 
their children’s responsiveness to language, number of words they can produce, eye-contact, anxiety, 
frequency of tantrums, eating, and difficulties falling asleep and sleeping through the night. Please see 
attached proposed script for the weekly call.  The qualitative data will be used to further inform and 
supplement quantitative data (total CARS 2 scores).  
 
The study will collect qualitative and quantitative data.  The quantitative data will be the total CARS2 
scores of the participants of both Control and Treatment groups, obtained before and after the study is 
done. Mixed Design Analysis of Variance will be used to analyze quantitative data. In addition, we will 
collect Before and After Prefrontal cortex EEG from the control and experimental treatment 
groups to measure electrophysiological changes in Prefrontal cortex. after treatment. EEG data 
will be analyzed (using Time-Frequency analysis),  and after baseline normalization, the data will 
be used  in aggregate to compare conditions numerically. The between group comparison before 
the treatment will be conducted using between subject T-test for each brainwave . The between 
group comparison will be conducted after treatment for each brain wave using between subject t-
test.  In addition, for the treatment condition only Before and After comparison will be conducted, 
using within subject t-test.    In addition, we will obtain qualitative data from weekly parental 
interviews, during which we will ask participants’ parents about their children’s behavior (see attached 
protocol).  Qualitative data will be used for information purposes and will supplement quantitative data. 
 
7.8 Blinding of the Researcher: Dr. Steingold (the PI) will not be present in the room when the child is 
receiving the treatment. She will not be aware what group each particular participant has been placed in. 
Dr. Steingold will be conducting the pre and post-testing interviews, as well as the on-going weekly 
interviews with the parents.  
 

 
Page 9 of 19 
 
Ms. Sverdlov will be present in the room when the child receives the treatment. However, Ms. Sverdlov 
will not be doing the CARS testing, she will not be doing the weekly interviews, and she will not be 
doing the data analysis 
 
Another professional (an independent contractor) will be analyzing the collected data at the end of the 
study, however, the individuals conducting the analysis will not have access to the private identifiable 
information and will not be aware about the specific group in which the individual participants have 
been placed. 
 
Confidentiality: Participants’ confidentiality will be protected by assigning them Study ID.  The 
quantitative data will be analyzed and reported only as aggregate (averages and F scores).  The 
qualitative data will be studied only by the researchers and, if reported for illustrative purposes only, it 
will be attached to the Study ID (not the identifying information).  The participants will be asked for 
consent to report qualitative data with the Study ID.  
 
 
8.0 
Recruitment Methods: 
 
We will put a flyer in both of Dr. Steingold’s offices, informing patients of this potential study. We will 
also give this flyer to various therapists in Brooklyn and Manhattan who work with children on the 
autism spectrum (such as ABA therapists, speech therapists, etc.). We will also put up this flyer in 
centers and schools that provides ABA therapy and other therapy to children on the spectrum. (Please 
see attached proposed flyer). 
 
Once a prospective parent contacts they researchers, they will be screened for eligibility. They will be 
asked questions regarding the Inclusion and Exclusion criteria. If the child is determined eligible, we 
will schedule their first session, which will start with debriefing about the purposes of the study, benefits 
and risks. After debriefing, participants will sign the Informed Consent (if they are still willing to 
participate), and proceed to the study. (Please see attached script for eligibility screening and obtaining 
Informed Consent). 
 
Withdrawal from the Study 
Each participant (and their  parents) has a right to withdraw from the study at any time. If a participant 
decides to withdraw from all components of a research study, we will discontinue interacting or 
intervening with the participant in order to obtain data about his  or her participation in the study, we 
will not obtain additional identifiable private information about the participant for the research study 
from any source, and we will not obtain identifiable private information about the participant for the 
research study by observing or recording private behavior without interacting with the participant.  
 
When a participant will inform us that he / she decides to withdraw, we will ask the participant to clarify 
whether the participant wishes to withdraw from all components of the trial or only from the primary 
interventional component of the trial. If the participant wishes to withdraw only from the primary 
interventional component, we may ask for permission to contact the participant to collect follow-up data 
about the child’s behavior.  
 

 
Page 10 of 19 
 
 
 
9.0 
Recommendation for Only One Parent Consent 
 
Both this proposed study and the investigational device do not involve greater than minimal risk.  
 
Rationale for the device:  
Safety of Photobiomodulation:  Photobiomodulation has been extensively studied on humans for more 
than 30 years, including its use for neurological conditions. There are several photobiomodulation 
products (for neurological conditions) that are on currently on the market (using both LED and Lasers). 
The consumers report no side-effects.  
After more than three decades of research there are no known major side effects attached to 
photobiomodulation therapy. 
Rare Minor Side effects for first time users only include:  Tiredness (temporary) – probably due to the 
release of metabolites but the majority report a resurgence of energy.  Headaches (temporary) – from the 
reactivation of neural connections and increased microcirculation. 
Safety Issues of our product specifically: Our product emits non-laser based irradiation (incoherent light) 
with a low level energy intensity. Infrared emits non-laser based irradiation (incoherent light) with a low 
level energy intensity. We use 850 nm.  The participants  might perceive slight warm. No other 
perceptions will be produced by wearing the device. No feelings of discomfort are anticipated (the 
device is especially made for children, it’s very comfortable and soothing to wear). There are no known 
side-effects of photobiomodulation (with 30 years of research and studies, including research on 5 year 
old children diagnosed with ASD). 
 
Rationale for the study: 
The study activities include: 1) wearing the device and / or 2) Listening to the audio program which 
provides language acquisition input or 3) free play while listening to nursery rhymes. In addition, the 
parents will be interviewed about the child’s behavior on a weekly basis.  
None of these activities present greater than minimal risk to the health and well-being of the 
participants.  
 
 
10.0 Consent Process 
 
Parents of child participants will be debriefed about the purposes of the study. They will be explained 
risks and benefits.  The researcher will answer all their questions.  The participants   will review the 
Informed Consent form. Parents will be given an opportunity to ask questions about the consent. The 
parents will be explained that they do not have any obligation to participate in the study and their refusal 
to participate will not affect any current treatment or benefits that they or their child currently receives. 
This explanation will take place in person, in Dr. Steingold’s office, in a private room. 
 
During the conversation, we will ask questions to ensure that the parent understands that the 
participation is voluntary, that the child may be placed in the placebo group, the time commitment 
required, the possible risks of being in the study and possible benefits.  
 

 
Page 11 of 19 
 
Prior to enrolling a child in the study, we will collect the signed Informed Consent from the parents of 
every participant.  
 
We will not be obtaining consent from the child participants. The reason is as follows: children 
between the ages 2 to 6 years, especially those diagnosed with ASD, have limited mental capacity 
and cannot be reasonably consulted about the risks and benefits of the study. Children will be asked 
to wear a device on their head. Due to their limited level of comprehension and responsiveness, they 
may not be able to give an affirmative verbal assent.  
Nonetheless, if children demonstrate a visible discomfort, or verbally say that they do not want to 
wear the device, they will not be forced to do it. 
 
 
11.0 Financial Compensation: 
 
No financial compensation will be provided.  
Parents of participants will be responsible for the cost of transportation to the research facilities.  
This is minimal risk to the participants.  
 
 
12.0 Potential Benefits to Participants:  
 
 
The possible benefit for the participant child may be improvement of speech, improvement of 
responsiveness, reduction of tantrums, reduction of anxiety, improvement of sleep, and 
improvement of eye contact.   
 
13.0 Risks to Participants: 
 
Potential Risks 
Mitigating Factors 
Some questions may be very personal or upsetting to the parents 
• Parents may 
skip any 
questions 
that they do 
not want to 
answer. 
The child may feel uncomfortable wearing the headband and may want 
to take it off early 
• If the child 
wants to 
take off the 
headband, 
we will first 
encourage 
him to wear 
it, by 
attempting 
to divert his 
attention to 
other things, 

 
Page 12 of 19 
 
such as toys 
and music.  
• If, however, 
the child 
insists on 
taking off 
the 
headband, 
he / she will 
not be 
forced to 
wear it and 
he / she may 
be able to 
take it off 
before the 
conclusion 
of the 
session.  
Breach of confidentiality (child’s data being seen by someone who 
shouldn’t have access to it) 
• We’ll keep 
all children 
identifying 
information 
separate 
from the 
research 
data, but 
we’ll be 
able to link 
it by using a 
study ID. 
We will 
destroy this 
link after we 
finish 
collecting 
and 
analyzing 
the data. 
If child is in the group that receives placebo (no active treatment), the 
child’s symptoms or condition may not improve and the parent will be 
upset 
• We are 
conducting 
the study to 
see the 
effects of 
photobiomo
dulation on 
young 
children 
diagnosed 
with ASD. 

 
Page 13 of 19 
 
If the effect 
is 
beneficial, 
the device 
may be 
available for 
treatment in 
the future 
and the 
particular 
child and 
other 
children 
may benefit 
from the 
outcome.  
  
The child maybe receiving 
concomitant medical 
treatment              
 
 
 
         
• Even though there are 
the tPBM with any med
currently receiving an
regular basis, will be e
participating in this pi
be determined during 
 
 
•  
 
• Even 
though 
there are 
no 
interactio
n of the 
tPBM with 
any 
medicatio
ns, 
children 
currently 
receiving 
any 
medicatio
ns on a 
regular 
basis, will 
be 
excluded 
from 
participati
ng in this 
pilot-
study. This 
will be 
determine
d during 
initial 
screening. 
 
    
The child might be 
receiving behavioral 
• There are no known in
treatment with any be
 
• There are 
no known 

 
Page 14 of 19 
 
Intervention such as ABA 
simultaneously with 
participating in the study.    
treatment. Yuli Fradkin, MD and Eugenia 
Steingold Ph.D will monitor (based on 
parental interviews and diaries) each 
child’s progress and if there are any 
changes (as reported by the parents) in 
children’s ability or willingness to relate 
to ABA therapists or benefit from ABA 
therapy, the parents will be offered to 
withdraw form the study. We think that 
negative  likelihood of such an 
interaction is extremely unlikely.  The 
positive interaction (e.g., children 
becoming more responsive to ABA 
therapy) will also be monitored and 
recorded in parental diaries.  The 
children should be able to receive their 
regular behavioral therapies while being 
enrolled in this study.  
 
 
interactio
n of this 
treatment 
with any 
behavioral 
treatment. 
Yuli 
Fradkin, 
MD and 
Eugenia 
Steingold 
Ph.D will 
monitor 
(based on 
parental 
interviews 
and 
diaries) 
each 
child’s 
progress 
and if 
there are 
any 
changes 
(as 
reported 
by the 
parents) 
in 
children’s 
ability or 
willingnes
s to relate 
to ABA 
therapists 
or benefit 
from ABA 
therapy, 
the 
parents 
will be 
offered to 
withdraw 
form the 
study. We 
think that 
negative  
likelihood 
of such an 

 
Page 15 of 19 
 
interactio
n is 
extremely 
unlikely.  
The 
positive 
interactio
n (e.g., 
children 
becoming 
more 
responsive 
to ABA 
therapy) 
will also 
be 
monitored 
and 
recorded 
in 
parental 
diaries.  
The 
children 
should be 
able to 
receive 
their 
regular 
behavioral 
therapies 
while 
being 
enrolled in 
this study.  
There may be risks that we do not know about yet. Exposure to LED 
lights is not known to have any negative side effects. 
• When the 
child will 
wear the 
headband, 
the child 
will be 
exposed to 
LED lights. 
The lights 
will be both 
red and near 
infra red. 
The lights 
will range in 
frequency 

 
Page 16 of 19 
 
from 660 
MHz to 850 
MHz.  
• After years 
of study, 
there are no 
known 
negative 
side effects 
of 
photobiomo
dulation.  
• Throughout 
the study, 
we’ll tell 
parents if 
we learn 
anything 
that might 
affect their 
decision to 
let their 
child 
participate.  
 
Some participants may have to be withdrawn from the study 
• If the child 
is not able 
to attend all 
the required 
sessions and 
the 
caregiver is 
not able to 
reschedule a 
cancelled 
session 
within a 3 
day 
window, 
then the 
child will 
have to be 
withdrawn 
from the 
study.  
• If the child 
becomes 
aggressive 
or self-
injurious 

 
Page 17 of 19 
 
during the 
session, 
then the 
child will 
have to be 
withdrawn 
from the 
study. 
• In that 
event, only 
the data that 
has been 
collected up 
to the date 
of 
withdrawal 
will be kept.  
• All 
identifying 
information 
will not be 
shared and 
all reports 
will be 
aggregated. 
• We will ask 
the child’s 
parents for 
permission 
to contact 
them in the 
future with 
follow up 
questions 
regarding 
the child’s 
behavior.  
 
    Furthermore, the study will be under oversight of Yuli Fradkin, MD, who is a board-
certified pediatric psychiatrist with more than 10 years of experience working with 
children  with ASD 
 
14.0 Provisions to Protect the Privacy and Confidentiality of Participants and the 
Research Data: 
 
Participants will be only interacting with Dr. Steingold or Ms. Sverdlov, Esq.   Participants and their 
parents will be tested individually, in a quiet room, and their confidentiality will be protected, as they 
won’t be interacting with each other or with anybody else outside of the researchers.  
 

 
Page 18 of 19 
 
The participants will be explained that they can refuse to answer any question.  They can also refuse to 
participate in the study at any time. We do not anticipate uncomfortable questions, however, we will 
assure the participants that their level of comfort is of utmost importance, and we will explain to them 
that there is no penalty involved for their refusal to answer any specific question.   
 
Only Dr. Steingold and Ms. Sverdlov will be able to access individual information.  The participants 
will be immediately assigned Study ID number and only STUDY ID will be used for data analysis and 
reporting.  Only aggregated data will be used for further reporting to the scientific community or to the 
business community.  Individual data will be reported for illustrative purposes only with STUDY ID 
(not identifying personal information).   
 
The following information will be included as data: Signed consent form (immediately scanned and 
stored in a cloud).  Pre and Post-test Cars2 scores (with STUDY ID assigned).  Weekly interview data 
(with STUDY ID assigned).   
 
Identifying information will include Name and Age, Gender and number of therapy hours of the 
participant, Name and phone number of the parent. Children’s  age, gender and number of therapy hours 
will be used for matching purposes (for assigning to the control or treatment condition).  Neither names 
of the participants nor names and phone numbers of their parents will be used for data analysis or 
reporting. Their names and phone numbers will be stored separately, in encrypted (password protected) 
file, in a secure cloud.  Secure clouds as well as encryption and password protection will be used to 
protect identifying information.  
 
The raw research data will be stored for 6 years. The identifying parental information will be kept for a 
year, for potential follow up interviews.  The consent form will include their permission to keep 
identifying data for a year.   
Although we do not plan to re-contact the participants after the study is complete, a follow up interview 
in 6 months or a year could be useful to assess the sustainability of the benefits of photobiomodulation.  
In this case, we will be applying for a separate IRB (minimal risks) to conduct the follow up interview. 
Presently, we do not plan to do it (although we recognize that it could potentially be useful for research 
purposes).  
 
The data will be stored in encrypted, password protected files in a secure cloud.  
 
 
15.0 Data Monitoring Plan to Ensure the Safety of Participants: 
 
We will conduct weekly interviews with the parents, asking them questions about child’s behavior and 
functioning to collect both safety and efficacy data. The interviews will be conducted either by 
telephone or in person (per parental choice).   Please attached interview protocol. Dr Steingold, a 
licensed clinical psychologist will review the data. The detailed qualitative data will be collected. No 
statistical analysis is necessary.   
 
If a participant shows sudden developmental regress, we will recommend immediate neurological 
evaluation and his/her participation will be discontinued (unless this participant has been manifesting 
regress prior the start of the study). If two participants suddenly manifests signs of regress (not 
anticipated, not seen before in prior photobiomodulation studies), we will immediately discontinue the 
study.  
 

 
Page 19 of 19 
 
16.0 Data, and if applicable, Specimen Banking:  
 
The raw research data will be stored for 6 years. The identifying parental information will be kept for a 
year, for potential follow up interviews.  The consent form will include their permission to keep 
identifying data for a year.   
 
Although we do not plan to re-contact the participants after the study is complete, a follow up interview 
in 6 months or a year could be useful to assess the sustainability of the benefits of photobiomodulation.  
In this case, we will be applying for a separate IRB (minimal risks) to conduct the follow up interview. 
Presently, we do not plan to do it (although we recognize that it could potentially be useful for research 
purposes).  
 
The data will be stored in encrypted, password protected files in a secure cloud.  
 
 
17.0 Data Sharing:  
 
Only aggregated data will be shared with scientific community (via publications). Only aggregated data 
will be shared with potential investors.  If individual data (e.g., from an interview) is shared for 
illustrative purposes, identifying information will NOT be shared (STUDY ID will be assigned to each 
participant).