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. 
 
 
May 1, 2022 

 
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PROTOCOL TITLE: 
 
Transcranial photobiomodulation for reducing autism symptoms in children.  
 
PRINCIPAL INVESTIGATOR: 
Name  
 
 
Yuli Fradkin, MD 
Department 
 
 
N/A 
Phone Number 
 
201-731-6244 
 
RESEARCHERS: 
Name  
 
 
Eugenia Steingold, Ph.D 
Department 
 
 
N/A 
Phone Number 
 
347-779-2473 
 
 
Name  
 
 
Katya Sverdlov, CFA, Esq. 
Department 
 
 
N/A 
Phone Number 
 
917-566-8151 
 
Name  
 
 
Elizaveta Logounova 
Department 
 
 
N/A 
Phone Number 
 
347-866-2966 
 
 
1.0 
Purpose of the study: 
 
The purpose of this 10-week 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, 2-7 years old, all of whom have recently 
completed the IRB approved study by JelikaLIte. They all 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).  
 
This will be an one-arm, open label study. Participants who were in the placebo condition in the  
previous study, will receive the treatment. Participants who were in the active condition in the previous 
study will repeat the course of treatment after the intermission of 3-6 months (depending on when they 
completed the study). 
 
The hypothesis to be tested is that exposure to photobiomodulation will reduce children’s symptoms of 
autism, as measured by the reduction of the Mean Scores of the Childhood Autism Rating Scales, 
compared to the initial baseline.  
 
 
 

 
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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.   
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.  
Photobiomodulation has 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. 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.   
Photobiomodulation is a mechanism for general cell healing: Light photons penetrate tissue and 
act on the cytochrome c oxidase photoreceptor in the mitochondria of the cell. This is an enzyme that 
catalyzes the final step in ATP production. In a healthy cell, cytochrome c oxidase combines oxygen 
with NADH (a crucial coenzyme in the making of ATP) to make the hydrogen ions that drive ATP 
production. 
When cells are damaged due to illness, stress, injury or aging, the mitochondria start making 
Nitric Oxide. This competes with oxygen and binds with cytochrome c oxidase stopping the production 
of ATP. Damaged cells also produce oxidative stress which leads to inflammation and cell death.  
The light photons from PBM (photobiomodulation) devices break the bond between nitric oxide and 
cytochrome c oxidase, which results in the following: 
● Nitric oxide (NO) is released into the bloodstream which increases circulation 
● Oxygen is able to combine with NADH so that ATP can be produced 
● Oxidative stress (ROS build up) is displaced 

 
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● ATP is produced at optimal levels again 
● Cells can work to regenerate tissue, fight infection, or perform whatever function they are 
programmed to do. 
 
This is how PBM works to reduce inflammation and pain, increase circulation and restore normal 
cell function in general, and there are multiple FDA approved photobiomodulation devices for wound 
healing, pain and inflammation (e.g., from Erchonia).  Since this mechanism works for all types of cells 
(e.g, including glial cells and neurons), this technology could potentially treat many conditions, 
including neurological conditions via tPBM (transcranial photobiomodulation), such as Depression, 
Stroke, TBI, Dementia, and Autism.  
There are several clinical trials that are ongoing regarding the efficacy of tPBM in treating 
neurological submissions. Shiffer (2020) showed with 22 participants that tPBM could also be effective 
for treating opioid cravings (NSF SBIR funded research).  There are also several new ongoing clinical 
trials with larger number of participants: Dan Iosifescu started (partially funded by NIMH) research in 
NYU Langone and Mass General Hospitals investigating how tPBM affects depression (with 30 
participants, randomized, placebo-controlled study, https://clinicaltrials.gov/ct2/show/NCT04366258 ). 
In addition, Iosifesku, Cassano and Ozorio started a Phase II clinical trial (with 125 participants, 
partially funded by NIH), investigating the effect of tPBM on Dementia and Alzheimer Disorder. 
(https://clinicaltrials.gov/ct2/show/NCT04784416). Cerganoglu started investigating how tPBM affects 
depression in a randomized controlled placebo controlled trial with 60 participants 
(https://clinicaltrials.gov/ct2/show/NCT04569058).  Furthermore, Cassano is starting studies on 23 
individuals with Down Syndrome ( https://clinicaltrials.gov/ct2/show/NCT04668001) 
 and on 60 children with ADD and Autistic traits (https://clinicaltrials.gov/ct2/show/NCT04569058). 
 
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).   
Transcranial photobiomodulation is likely to be especially effective for ASD (autism spectrum 
disorder), as recent research has shown that ASD is associated with the inflammation of non-neuronal 
glial cells (astrocyte and oligodendrocyte). Furthermore, Nassir et al, 2021, identified multiple single-
cell clusters from three distinct developmental human brain regions (anterior cingulate cortex, middle 
temporal gyrus and primary visual cortex) with high concentration of inflamed glial cells. Cognilum 
stimulates targeted brain areas including those areas (e.g., occipital lobe and middle temporal gyrus) 
with high concentration of the inflamed glial cells. In addition, stimulating targeted brain areas 
simultaneously improves their functional brain connectivity (which is also crucial for ASD). Overall, 
many researchers seem to agree that ASD could be a result of Mitochondrial disturbances, which leads 

 
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to brain disconnectedness and tPBM could be beneficial for increasing ATP, promoting brain 
connectivity and reducing symptoms of ASD.   
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) 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).  
It should be noticed that even though the same technology (tPBM) is used for different condition, 
the devices are different (they irradiate different brain areas, the pulsing is different, the wavelength of 
the light and the power).  JelikaLite’s Cognilum device specifically irradiates brain areas affected by 
autism.Therefore, even though this technology is used for various conditions, our device is specifically 
designed to reduce symptoms of Autism. Please see section 2.4 below – for the description of the results 
of our recent IRB-approved study.  
Jelikalite recently completed a study with the same group of participants who are proposed to 
enroll in this follow-up study. There was a statistically  significant reduction in CARS scores in the 
Active Condition, but not in the Placebo Condition (Fradking et al, 2021).  
 
2.2   Publications:  
 
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 
● WE NEED TO INCLUDE FRADKIN (from Rucares). 
 
2.3 Background of the Cognilum Physical Device:  

 
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We are developing a safe and effective protocol for administering tPBM via a wearable device. 
This physical device is getting developed by JelikaLite Corp. The parameters are developed by Dr. 
Eugenia Steingold (the researcher 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 is 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 
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). 
This device received a Non-Significant Risk Designation from the FDA and it was used in 
the completed, IRB approved study by Jelikalite.  
 
2.4 Results of the Previous Pilot Study using the same device 

 
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Our recently concluded pilot study collaborates these predictions. We enrolled 30 participants who were 
2-6 year old (16 in active and 14 in sham-control condition). Participants in the active condition have 
improved significantly (as measured by Childhood Autism Rating Scale). Participants in the sham 
condition showed no such improvement (see Chart 1).  Furthermore, EEG data showed reduction of 
Delta waves over the course of the study for the participants of Active condition only (see Chart 2).  
Frolich et al (2021) reported that high amplitude Delta waves in the wakeful state are associated with 
neurological disorders and mitochondria disorders. Therefore, this reduction of Delta waves is a 
signature of the brain healing process (see attached presentation by Naviaux, 2021). Lastly, the change 
in Delta correlated significantly with the change in CARS showing that the kids whose CARS scores 
reduced (reflecting their reduction of symptoms) also experienced reduction in their Delta waves (see 
Chart 3).  Lastly, we also found an increase in Theta waves in the children, whose CARS score 
decreased (inverse correlation between intensity of Theta and CARS scores, see Chart 4). Recent 
research has shown that there is an insufficient intensity of Theta waves in the children diagnosed of 
ASD (e.g., Ortiz-Mantilla et al, 2019). This redistribution of brain waves from Delta to Theta in the 
active condition is signaling of the healing that’s happening as a result of treatment with tPBM.  
 
(See attached Charts 1-4 with exact statistics below). 
 
Chart 1: There was a significant reduction in CARS score in the Active Condition only (F=6.47 , 
p<.05). 
 
 
Chart 2: Delta Waves reduced in the Active Condition: Pearson’s R squared -.45,(p<.05, n=9) 
However, this correlation was not significant for the Placebo Condition, Pearson’s R squared is -.1, 
(p>.1, n=8). 
 

 
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Chart 3: The study revealed a statistically significant correlation between the change in CARSII scores 
and Change in Delta waves (n=15). Specifically, children (mostly in Active condition), who experienced 
reduction in CARSII also experienced reduction in Delta waves. 
 
 
 
Chart 4: Increase in Theta waves correlated with Decrease in CARSII.  
 

 
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3.0 
Safety of the Device 
 
The device has been designated as “Non-Significant Risk” by the FDA in November 2020.  
 
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.  
 
4.0 
Inclusion and Exclusion Criteria: 
 
Inclusion Criteria:  
1. Male or female participants between 2 years and 7 years of age (inclusive), of all races.   
2. Previously diagnosed with moderate or severe ASD by a licensed professional. 
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 

 
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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.      
9. Participant previously participated in the JelikaLite pivotal clinical trial that took place in 2021, either 
in the active or placebo conditions.  
 
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. 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).  
7. Current treatment with a psychotropic medication.  
8. Investigator and his/her immediate family, defined as the investigator's child or grandchild.  
 
 
5.0 
Sample Size: 
 
Up to 30 children will be included in the study. All the screening has been done already, as we anticipate 
bringing back the children who already participated in the previous study, described in 2.4 above.  
 
 
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.  

 
Page 10 of 18 
 
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 will be only one active condition.  
7.3 Participants: The participants will be 2 to 7 years old children previously diagnosed with moderate 
or severe ASD. Children of all genders and races will be included in this study.  
7.4 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 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).  
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.   
7.5  Pre and Post-Testing:  
The following measurements will be used for pretest and post-test.  
o Childhood Autism Rating Scale (CARS2)  
CARS 2 scores will be compared for analyses. 
In addition, EEG will be collected from the participants pre and post -treatment in each session. Mobile 
FDA cleared EEG device from Brain Scientific will be used to collect children’s pre and post test EEG.  

 
Page 11 of 18 
 
There is no known danger of EEG collecting. In this study it will be using for measuring the efficacy 
treatment only. 
7.6 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.  
The study will collect qualitative and quantitative data.  The quantitative data will be the total CARS2 
scores of the participants, obtained before and after the study is done. Repeated-measure t-tests 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.    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.  
 
The PI will analyze quantitative and qualitative data. An independent contractor (a neuroscientist) will 
be analyzing the collected EEG data at the end of the study, however, the individuals conducting the 
analysis will not have access to the private identifiable information. 
7.8  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 contact via phone call the parents of children who have participated in our previous study, 
approved by the WCG IRB under IRB Tracking ID  120200004.  
 
Once a prospective parent contacts the researchers, they will be re-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 

 
Page 12 of 18 
 
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.  
 
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. 
The device has been designated as “Non-Significant Risk” by the FDA.  
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). 

 
Page 13 of 18 
 
 
Rationale for the study: 
The study activities include: 1) wearing the device and / or r 2) free play. 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.  
 
 

 
Page 14 of 18 
 
 
 
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.  
 
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 7 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.   
 
 
 
 

 
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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, 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. 
The child maybe receiving concomitant medical 
treatment              
 
 
Even though there are no interaction of the tPBM with 
any medications, children currently receiving any 
psychotropic medications on a regular basis, will be 
excluded from participating in this pilot-study. This 
will be determined during initial screening. 
 
The child might be receiving behavioral Intervention 
such as ABA simultaneously with participating in the 
study.                       
There is no known negative interaction of this 
treatment with any behavioral treatment.  
The children should be able to receive their regular 
behavioral therapies while being enrolled in this 
study. 
Clinicians will monitor (based on parental and 
therapists’ interviews) each child’s progress. 
There may be risks that we do not know about yet. 
Exposure to LED lights is not known to have any 
negative side effects. 
After years of study, there are no known negative side 
effects of photobiomodulation.  
Throughout the study, we’ll tell parents if we learn 
anything that might affect their decision to let their 
child participate.  
Minor transient side effects may include headaches, 
agitation, and hyper-activity. These side effects are 
sometimes observed in the beginning of the treatment 
and usually resolve on their own.  Parents will be 
informed of these potential minor side-effects in the 
Consent form.  
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 7-day window, then the 
child may have to be withdrawn from the study.  

 
Page 16 of 18 
 
1. 
If the child has completed at least 8 weeks, we 
will ask them to do final assessments and this data 
will be included in the final analysis. 
2. 
If the child has completed less than 8 weeks 
and missed a week due to sickness, the family will be 
offered to restart the 12-week course.  
Regardless of the outcome, we will ask the child’s 
parents for permission to contact them in the future 
with follow up questions regarding the child’s 
behavior. 
 
 
14.0 Provisions to Protect the Privacy and Confidentiality of Participants and the Research Data: 
 
Participants will be only interacting with Dr. Steingold, Ms. Sverdlov, Esq, or Ms. Logounova 
(researcher).   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.  
 
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.   

 
Page 17 of 18 
 
 
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 manifest signs of regress (not 
anticipated, not seen before in prior photobiomodulation studies), we will immediately discontinue the 
study.  
 
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:  
 

 
Page 18 of 18 
 
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).