Study Summary
This trial will test if a treatment called transcranial photobiomodulation can help reduce symptoms of autism in young children.
- Autism
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 0 Secondary · Reporting Duration: 8 weeks
Trial Safety
Trial Design
2 Treatment Groups
CognilumTM
1 of 2
Placebo condition
1 of 2
Experimental Treatment
Non-Treatment Group
30 Total Participants · 2 Treatment Groups
Primary Treatment: Cognilum TM: Light Treatment Condition · Has Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 2 - 6 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| New York | 50.0% |
| Pennsylvania | 33.3% |
| New Jersey | 16.7% |
How old are they?
| < 18 | 50.0% |
| 18 - 65 | 50.0% |
What site did they apply to?
| Dr. Steingold Psychology PC | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How many prior treatments have patients received?
| 0 | 100.0% |
How responsive is this trial?
Typically responds via
| Phone Call | 100.0% |
Most responsive sites:
- Dr. Steingold Psychology PC: < 24 hours
Average response time
- < 1 Day
- Leisman, Gerry, Calixto Machado, Yanin Machado, and Mauricio Chinchilla-Acosta. 2018. “Effects of Low-level Laser Therapy in Autism Spectrum Disorder”. Advances in Experimental Medicine and Biology. Springer International Publishing. doi:10.1007/5584_2018_234.
- Henderson, Theodore A., and Larry Morries. 2015. “Near-infrared Photonic Energy Penetration: Can Infrared Phototherapy Effectively Reach the Human Brain?”. Neuropsychiatric Disease and Treatment. Informa UK Limited. doi:10.2147/ndt.s78182.
- Khuman, Jugta, Jimmy Zhang, Juyeon Park, James D. Carroll, Chad Donahue, and Michael J. Whalen. 2012. “Low-level Laser Light Therapy Improves Cognitive Deficits and Inhibits Microglial Activation After Controlled Cortical Impact in Mice”. Journal of Neurotrauma. Mary Ann Liebert Inc. doi:10.1089/neu.2010.1745.
- Hamblin, Michael R.. 2016. “Shining Light on the Head: Photobiomodulation for Brain Disorders”. BBA Clinical. Elsevier BV. doi:10.1016/j.bbacli.2016.09.002.
- Bosl, William J., Helen Tager-Flusberg, and Charles A. Nelson. 2018. “EEG Analytics for Early Detection of Autism Spectrum Disorder: A Data-driven Approach”. Scientific Reports. Springer Science and Business Media LLC. doi:10.1038/s41598-018-24318-x.
- Weissman, Jacqueline R., Richard I. Kelley, Margaret L. Bauman, Bruce H. Cohen, Katherine F. Murray, Rebecca L. Mitchell, Rebecca L. Kern, and Marvin R. Natowicz. 2008. “Mitochondrial Disease in Autism Spectrum Disorder Patients: A Cohort Analysis”. Edited by Raphael Schiffmann. Plos ONE. Public Library of Science (PLoS). doi:10.1371/journal.pone.0003815.
- Hamblin MR. Shining light on the head: Photobiomodulation for brain disorders. BBA Clin. 2016 Oct 1;6:113-124. doi: 10.1016/j.bbacli.2016.09.002. eCollection 2016 Dec.
- Henderson TA, Morries LD. Near-infrared photonic energy penetration: can infrared phototherapy effectively reach the human brain? Neuropsychiatr Dis Treat. 2015 Aug 21;11:2191-208. doi: 10.2147/NDT.S78182. eCollection 2015.
- 2020. "Transcranial Photobiomodulation for Reducing Autism Symptoms in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04660552.
Frequently Asked Questions
Are participants younger than 45 years of age eligible for this research?
"As per the inclusion criteria for this medical study, only those between 2 and 6 years of age are eligible. The trial boasts 228 studies that involve children under 18-years-old and 42 research projects focusing on patients over 65." - Anonymous Online Contributor
What criteria must an individual fulfill to participate in this research project?
"This autism spectrum disorder study is seeking 30 participants aged between 2 and 6 years old." - Anonymous Online Contributor
What is the total population for this medical trial's enrollment?
"Affirmative. The clinicaltrial.gov website shows that this research study, which was initially announced on November 15th 2020, is still looking for applicants. A total of 30 people are needed across 2 different medical facilities." - Anonymous Online Contributor
Are new participants being accepted into the trial at this time?
"As per the information on clinicaltrials.gov, this medical experiment is actively seeking participants and has been open for application since November 15th 2020 with its most recent update following shortly after on December 7th of that same year." - Anonymous Online Contributor