Trial Outcomes & Findings for Safety and Efficacy of tPBM for Epileptiform Activity in Autism (NCT NCT06352372)
NCT ID: NCT06352372
Last Updated: 2026-07-31
Results Overview
The CARS is a measure of autism severity completed by a clinician. Lower Score is Better. Scores range from 15 to 60.
COMPLETED
PHASE2
6 participants
Baseline, Week 5, Week 11 and Week 15 (One Month Follow-Up)
2026-07-31
Participant Flow
Participant milestones
| Measure |
Near Infra-red (NIR) Light - Transcranial Photobiomodulation (tPBM) - to the Brain of Autistic Child
This is a prospective, open level study examining the safety and effectiveness of treatment with individuals with active seizures and/or EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM).
noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM): The proposed intervention will be noninvasively delivered 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 expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.
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Overall Study
STARTED
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6
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Overall Study
COMPLETED
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6
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
it does not differ
Baseline characteristics by cohort
| Measure |
Near Infra-red (NIR) Light - Transcranial Photobiomodulation (tPBM) - to the Brain of Autistic Child
n=6 Participants
This is a prospective, open level study examining the safety and effectiveness of treatment with individuals with active seizures and/or EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM).
noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM): The proposed intervention will be noninvasively delivered 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 expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.
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Age, Continuous
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8.1 years
STANDARD_DEVIATION 4.0 • n=9 Participants
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Sex: Female, Male
Female
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1 Participants
n=9 Participants • it does not differ
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Sex: Female, Male
Male
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5 Participants
n=9 Participants • it does not differ
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=9 Participants • if does not differ
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Race (NIH/OMB)
Asian
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0 Participants
n=9 Participants • if does not differ
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=9 Participants • if does not differ
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Race (NIH/OMB)
Black or African American
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1 Participants
n=9 Participants • if does not differ
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Race (NIH/OMB)
White
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5 Participants
n=9 Participants • if does not differ
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Race (NIH/OMB)
More than one race
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0 Participants
n=9 Participants • if does not differ
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=9 Participants • if does not differ
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=9 Participants • It do not differ
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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6 Participants
n=9 Participants • It do not differ
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=9 Participants • It do not differ
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Region of Enrollment
United States
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6 Participants
n=9 Participants
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PRIMARY outcome
Timeframe: Baseline, Week 5, Week 11 and Week 15 (One Month Follow-Up)Population: One subject did not return for CARS assessment after simulation was complete (week 11) and two subjects did not return for one month follow-up.
The CARS is a measure of autism severity completed by a clinician. Lower Score is Better. Scores range from 15 to 60.
Outcome measures
| Measure |
Near Infra-red (NIR) Light - Transcranial Photobiomodulation (tPBM) - to the Brain of Autistic Child
n=6 Participants
This is a prospective, open level study examining the safety and effectiveness of treatment with individuals with active seizures and/or EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM).
noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM): The proposed intervention will be noninvasively delivered 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 expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.
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Childhood Autism Rating Scores (CARS)
Baseline
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37.7 units on the CARS scale
Standard Error 0.7
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Childhood Autism Rating Scores (CARS)
Midpoint at week 5
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36.7 units on the CARS scale
Standard Error 0.9
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Childhood Autism Rating Scores (CARS)
Final at week 11
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34.2 units on the CARS scale
Standard Error 1.1
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Childhood Autism Rating Scores (CARS)
Week 15 (One Month Follow-Up)
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37.4 units on the CARS scale
Standard Error 1.3
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SECONDARY outcome
Timeframe: Before Treatment and EEG following treatment (within 6 months)Delta power is a measures of the amount of brain activity in the delta frequency as measured by overnight EEG
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 11 and Week 15 (One Month Follow-Up)Population: Patients were followed clinically so return for visits was not necessary for seizure reporting.
Seizure log will record the seizure severity and frequency
Outcome measures
| Measure |
Near Infra-red (NIR) Light - Transcranial Photobiomodulation (tPBM) - to the Brain of Autistic Child
n=6 Participants
This is a prospective, open level study examining the safety and effectiveness of treatment with individuals with active seizures and/or EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM).
noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM): The proposed intervention will be noninvasively delivered 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 expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.
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Seizure Frequency
Baseline
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0.08 Seizures per Week
Standard Error 0.09
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Seizure Frequency
Week 11
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0.03 Seizures per Week
Standard Error 0.04
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Seizure Frequency
Week 15 (One Month Follow-Up)
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0 Seizures per Week
Standard Error 0
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 11 and Week 15 (One Month Follow-Up)The SRS is a caregiver report of autism symptoms Lower Score is Better, Scores range from 30 to 90 (T-scores)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 11Population: 5 of the 6 participants complied with clinician week 1 visit
The CGI measures the overall disease change. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.
Outcome measures
| Measure |
Near Infra-red (NIR) Light - Transcranial Photobiomodulation (tPBM) - to the Brain of Autistic Child
n=5 Participants
This is a prospective, open level study examining the safety and effectiveness of treatment with individuals with active seizures and/or EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM).
noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM): The proposed intervention will be noninvasively delivered 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 expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.
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Clinical Global Impression Scale (CGI) Improvement
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2.6 Units on a Scale
Standard Error 0.27
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 11 and Week 15 (One Month Follow-Up)The NIH ToolBox is a set of short assessments for neurodevelopmental assessments. Direction of score depends on individual subtest.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 11Population: 1 patient did not return for the week 11 clinician assessment.
CGI Improvement Type Scale Specific for Social Interactions: It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.
Outcome measures
| Measure |
Near Infra-red (NIR) Light - Transcranial Photobiomodulation (tPBM) - to the Brain of Autistic Child
n=5 Participants
This is a prospective, open level study examining the safety and effectiveness of treatment with individuals with active seizures and/or EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM).
noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM): The proposed intervention will be noninvasively delivered 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 expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.
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OACIS Social Interaction
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3.2 Units on a Scale
Standard Error 0.42
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OTHER_PRE_SPECIFIED outcome
Timeframe: Week 11Population: 1 participant did not return for the week 11 visit
CGI Improvement Type Scale Specifically for Aberrant Behaviors. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.
Outcome measures
| Measure |
Near Infra-red (NIR) Light - Transcranial Photobiomodulation (tPBM) - to the Brain of Autistic Child
n=5 Participants
This is a prospective, open level study examining the safety and effectiveness of treatment with individuals with active seizures and/or EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM).
noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM): The proposed intervention will be noninvasively delivered 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 expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.
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OACIS Aberrant Behaviors
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3.2 Units on a Scale
Standard Error 0.42
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OTHER_PRE_SPECIFIED outcome
Timeframe: Week 11 AssessmentCGI Improvement Type Scale Specifically for Repetitive Behaviors. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.
Outcome measures
| Measure |
Near Infra-red (NIR) Light - Transcranial Photobiomodulation (tPBM) - to the Brain of Autistic Child
n=5 Participants
This is a prospective, open level study examining the safety and effectiveness of treatment with individuals with active seizures and/or EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM).
noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM): The proposed intervention will be noninvasively delivered 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 expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.
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OACIS Repetitive Behaviors
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3.4 Units on a Scale
Standard Error 0.45
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OTHER_PRE_SPECIFIED outcome
Timeframe: Week 11Population: 1 participant did not return for week 11 visit
CGI Improvement Type Scale Specifically for Verbal communication. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.
Outcome measures
| Measure |
Near Infra-red (NIR) Light - Transcranial Photobiomodulation (tPBM) - to the Brain of Autistic Child
n=5 Participants
This is a prospective, open level study examining the safety and effectiveness of treatment with individuals with active seizures and/or EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM).
noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM): The proposed intervention will be noninvasively delivered 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 expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.
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OACIS Verbal Communication
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2.8 Units on a Scale
Standard Error 0.42
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OTHER_PRE_SPECIFIED outcome
Timeframe: Week 11CGI Improvement Type Scale Specifically for Nonverbal communication. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.
Outcome measures
| Measure |
Near Infra-red (NIR) Light - Transcranial Photobiomodulation (tPBM) - to the Brain of Autistic Child
n=5 Participants
This is a prospective, open level study examining the safety and effectiveness of treatment with individuals with active seizures and/or EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM).
noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM): The proposed intervention will be noninvasively delivered 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 expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.
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OACIS Nonverbal Communication
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3.4 Units on a Scale
Standard Error 0.45
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OTHER_PRE_SPECIFIED outcome
Timeframe: Week 11CGI Improvement Type Scale Specifically for Hyperactivity. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.
Outcome measures
| Measure |
Near Infra-red (NIR) Light - Transcranial Photobiomodulation (tPBM) - to the Brain of Autistic Child
n=5 Participants
This is a prospective, open level study examining the safety and effectiveness of treatment with individuals with active seizures and/or EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM).
noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM): The proposed intervention will be noninvasively delivered 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 expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.
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OACIS Hyperactivity
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3.2 Units on a Scale
Standard Error 0.42
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OTHER_PRE_SPECIFIED outcome
Timeframe: Week 11CGI Improvement Type Scale Specifically for Anxiety. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.
Outcome measures
| Measure |
Near Infra-red (NIR) Light - Transcranial Photobiomodulation (tPBM) - to the Brain of Autistic Child
n=5 Participants
This is a prospective, open level study examining the safety and effectiveness of treatment with individuals with active seizures and/or EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM).
noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM): The proposed intervention will be noninvasively delivered 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 expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.
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OACIS Anxiety
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3.6 Units on a Scale
Standard Error 0.57
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OTHER_PRE_SPECIFIED outcome
Timeframe: Week 11Population: one participant did not return for week 11 assessment visit
CGI Improvement Type Scale Specifically for Sensory Sensitivity. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.
Outcome measures
| Measure |
Near Infra-red (NIR) Light - Transcranial Photobiomodulation (tPBM) - to the Brain of Autistic Child
n=5 Participants
This is a prospective, open level study examining the safety and effectiveness of treatment with individuals with active seizures and/or EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM).
noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM): The proposed intervention will be noninvasively delivered 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 expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.
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OACIS Sensory Sensitivity
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3.6 Units on a Scale
Standard Error 0.45
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OTHER_PRE_SPECIFIED outcome
Timeframe: Week 11Population: one participant did not return for Week 11 clinical assessment.
CGI Improvement Type Scale. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.
Outcome measures
| Measure |
Near Infra-red (NIR) Light - Transcranial Photobiomodulation (tPBM) - to the Brain of Autistic Child
n=5 Participants
This is a prospective, open level study examining the safety and effectiveness of treatment with individuals with active seizures and/or EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM).
noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM): The proposed intervention will be noninvasively delivered 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 expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.
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OACIS Restricted Behavior
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3.6 Units on a Scale
Standard Error 0.45
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OTHER_PRE_SPECIFIED outcome
Timeframe: Week 11Population: One participant did not return for week 11 clinical assessment.
CGI Improvement Type Scale Specific for Autism symptoms. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.
Outcome measures
| Measure |
Near Infra-red (NIR) Light - Transcranial Photobiomodulation (tPBM) - to the Brain of Autistic Child
n=5 Participants
This is a prospective, open level study examining the safety and effectiveness of treatment with individuals with active seizures and/or EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM).
noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM): The proposed intervention will be noninvasively delivered 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 expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.
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|---|---|
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OACIS Autism Symptoms
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2.6 Units on a Scale
Standard Error 0.27
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Adverse Events
Near Infra-red (NIR) Light - Transcranial Photobiomodulation (tPBM) - to the Brain of Autistic Child
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Near Infra-red (NIR) Light - Transcranial Photobiomodulation (tPBM) - to the Brain of Autistic Child
n=6 participants at risk
This is a prospective, open level study examining the safety and effectiveness of treatment with individuals with active seizures and/or EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM).
noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM): The proposed intervention will be noninvasively delivered 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 expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.
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Psychiatric disorders
Hand Flapping
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16.7%
1/6 • From enrollment until end of follow-up
From enrollment until end of one month follow-up at 15 weeks
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Psychiatric disorders
Hyperactivity
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16.7%
1/6 • From enrollment until end of follow-up
From enrollment until end of one month follow-up at 15 weeks
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General disorders
Insomnia
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33.3%
2/6 • From enrollment until end of follow-up
From enrollment until end of one month follow-up at 15 weeks
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Respiratory, thoracic and mediastinal disorders
Nasal Congestion
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16.7%
1/6 • From enrollment until end of follow-up
From enrollment until end of one month follow-up at 15 weeks
|
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Psychiatric disorders
Restlessness
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33.3%
2/6 • From enrollment until end of follow-up
From enrollment until end of one month follow-up at 15 weeks
|
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Nervous system disorders
Seizure
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16.7%
1/6 • From enrollment until end of follow-up
From enrollment until end of one month follow-up at 15 weeks
|
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Psychiatric disorders
Self-Injurious Behavior
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16.7%
1/6 • From enrollment until end of follow-up
From enrollment until end of one month follow-up at 15 weeks
|
|
General disorders
Tantrums
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33.3%
2/6 • From enrollment until end of follow-up
From enrollment until end of one month follow-up at 15 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place