Autism Spectrum DisorderIPMR ASDNCT06006637
Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder
A study testing Cognilum TM: Light Treatment Condition in people with Autism Spectrum Disorder, run by State University of New York - Upstate Medical University at 2 sites in United States.
Trial summary
This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical University and Mt. Sinai Medical Center with 80 autistic children evaluating the effects of transcranial photobiomodulation (tPBM) on multiple clinically validated scales. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Cognilum TM: Light Treatment Condition
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Oct 2023to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 2 - 8
- Autism spectrum disorder diagnosis
- CARS-2 score of 30 - 45
Who cannot join
- CARS scores less than 30 or over 45.
- Taking psychotropic medications.
- Having skin lesions on scalp
- Having history of seizures
- Having history of abnormal EEG
- Being a relative of the PI or a researcher
- Having implanted devices (including cochlear implants).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mt. Sinai Medical Center
New York, New York, 10029
Alexander Kolevzon, MD, 212-659-8752, alexander.kolevzon@mssm.edu
Catherine Sancimino, PhD, catherine.sancimino@mssm.edu
- Recruiting
Golisano Center for Special Needs
Syracuse, New York, 13210
Henry S Roane, PhD, 315-464-3555, roaneh@upstate.edu
About this study
This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical University and Mt. Sinai Medical Center with 80 autistic children evaluating the effects of transcranial photobiomodulation (tPBM) on multiple clinically validated scales.
Read the detailed description
The proposed intervention will noninvasively deliver near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The Cognilum system is a non-invasive headband medical device specifically designed to safely and comfortably deliver tPBM to autistic children. Cognilum has been designated as a non-significant risk breakthrough device by the Food and Drug Administration. This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical University and Mt. Sinai with 80 autistic children using Cognilium device and measuring the impact using multiple clinically validated scales.
Hypothesis 1: Significant reduction of average Childhood Autism Rating Scores (CARS; before and after treatment comparison) in the active group compared to sham-control group.
Hypothesis 2: Significant change in average scores (before and after treatment comparison) on the Social Responsiveness Scale (SRS), and Clinical Global Impression - Improvement (CGI-I) scale in the active group compared to sham control group.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Cognilum TM: Light Treatment Condition
- Keywords
- Transcranial photobiomodulation, Autism Spectrum Disorder
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognilum TM: Light Treatment ConditionDevice
The children will wear the CognilumTM device for approximately 10 minutes at a time, twice a week, for a period of 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CognilumTM | Experimental | During the study participants will be wear the transcranial photobiomodulation device Cognilum. The device will administer the stimulation of near infrared light (830nm) to specific areas of the child's brain. Receives: Device: Cognilum TM: Light Treatment Condition |
| Sham control | Sham comparator | During the study participants will wear the transcranial photobiomodulation device. The device will not be turned on and therefore no brain stimulation with near infrared light (830nm) will be provided. Receives: Device: Cognilum TM: Light Treatment Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childhood Autism Rating Scale, Second edition
Psychometrically sound measure for identifying children with autism and their symptom severity through quantifiable ratings based on direct observation. Raw scores may range from 15 to 60, which are then converted to T-scores. Higher scores indicate greater severity.
Measured: 10 weeks
Secondary outcomes (2)
Social Responsiveness Scale, Second Edition
Psychometrically sound measure for identifying the presence and severity of social impairment within the autism spectrum and differentiates it from that which occurs in other disorders. Raw scores may range from 65 to 260, which are then converted to T-scores. Higher scores indicate greater severity.
Measured: 10 weeks
Clinical Global Impressions Scale
A well-established, brief assessment of the clinician's view of the patient's global functioning prior to and after initiating intervention. Ratings range from 1 (Normal) to 7 (Among the most severe).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start17 Oct 2023
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Randomized, Sham-controlled, Double Blind, Mixed-Design study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- JelikaLite LLC, Mt. Sinai School of Medicine, New York, New York, MetroEHS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006637
- Sponsor's protocol ID
- 2041726
- Other IDs
- 111111
- Acronym
- IPMR ASD
- Status last verified
- Dec 2024
- First submitted
- 17 Aug 2023
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual participant data (IPD) will be available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06006637
- Acronym / sponsor ID
- IPMR ASD / 2041726
- Conditions
- Autism Spectrum Disorder
- Keywords
- Transcranial photobiomodulation, Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- JelikaLite LLC, Mt. Sinai School of Medicine, New York, New York, MetroEHS
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical University and Mt. Sinai Medical Center with 80 autistic children evaluating the effects of transcranial photobiomodulation (tPBM) on multiple clinically validated scales.
Detailed description
The proposed intervention will noninvasively deliver near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The Cognilum system is a non-invasive headband medical device specifically designed to safely and comfortably deliver tPBM to autistic children. Cognilum has been designated as a non-significant risk breakthrough device by the Food and Drug Administration. This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical University and Mt. Sinai with 80 autistic children using Cognilium device and measuring the impact using multiple clinically validated scales.
Hypothesis 1: Significant reduction of average Childhood Autism Rating Scores (CARS; before and after treatment comparison) in the active group compared to sham-control group.
Hypothesis 2: Significant change in average scores (before and after treatment comparison) on the Social Responsiveness Scale (SRS), and Clinical Global Impression - Improvement (CGI-I) scale in the active group compared to sham control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a Randomized, Sham-controlled, Double Blind, Mixed-Design study
| Arm | Type | Receives |
|---|---|---|
| CognilumTM | Experimental | Device: Cognilum TM: Light Treatment ConditionDuring the study participants will be wear the transcranial photobiomodulation device Cognilum. The device will administer the stimulation of near infrared light (830nm) to specific areas of the child's brain. |
| Sham control | Sham comparator | Device: Cognilum TM: Light Treatment ConditionDuring the study participants will wear the transcranial photobiomodulation device. The device will not be turned on and therefore no brain stimulation with near infrared light (830nm) will be provided. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ages 2 - 8
- Autism spectrum disorder diagnosis
- CARS-2 score of 30 - 45
Key exclusion criteria (7 listed)
- CARS scores less than 30 or over 45.
- Taking psychotropic medications.
- Having skin lesions on scalp
- Having history of seizures
- Having history of abnormal EEG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognilum TM: Light Treatment ConditionThe children will wear the CognilumTM device for approximately 10 minutes at a time, twice a week, for a period of 10 weeks. | Device | CognilumTM, Sham control |
Primary outcome
Childhood Autism Rating Scale, Second edition
Time frame: 10 weeks
Psychometrically sound measure for identifying children with autism and their symptom severity through quantifiable ratings based on direct observation. Raw scores may range from 15 to 60, which are then converted to T-scores. Higher scores indicate greater severity.
2 secondary outcomes
Social Responsiveness Scale, Second Edition
Time frame: 10 weeks
Clinical Global Impressions Scale
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognilum TM: Light Treatment Condition in people with Autism Spectrum Disorder, run by State University of New York - Upstate Medical University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William E Sullivan, PhD (315-464-3932, sullivaw@upstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childhood Autism Rating Scale, Second edition (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.