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. 2024 Apr 26:15:1221193.
doi: 10.3389/fneur.2024.1221193. eCollection 2024.

Transcranial photobiomodulation in children aged 2-6 years: a randomized sham-controlled clinical trial assessing safety, efficacy, and impact on autism spectrum disorder symptoms and brain electrophysiology

Yuliy Fradkin  1 , Luis De Taboada  2 , Margaret Naeser  3 , Anita Saltmarche  4 , William Snyder  5 , Eugenia Steingold  2
Affiliations

Transcranial photobiomodulation in children aged 2-6 years: a randomized sham-controlled clinical trial assessing safety, efficacy, and impact on autism spectrum disorder symptoms and brain electrophysiology

Yuliy Fradkin et al. Front Neurol. .

Abstract

Background: Small pilot studies have suggested that transcranial photobiomodulation (tPBM) could help reduce symptoms of neurological conditions, such as depression, traumatic brain injury, and autism spectrum disorder (ASD).

Objective: To examine the impact of tPBM on the symptoms of ASD in children aged two to six years.

Method: We conducted a randomized, sham-controlled clinical trial involving thirty children aged two to six years with a prior diagnosis of ASD. We delivered pulses of near-infrared light (40 Hz, 850 nm) noninvasively to selected brain areas twice a week for eight weeks, using an investigational medical device designed for this purpose (Cognilum™, JelikaLite Corp., New York, United States). We used the Childhood Autism Rating Scale (CARS, 2nd Edition) to assess and compare the ASD symptoms of participants before and after the treatment course. We collected electroencephalogram (EEG) data during each session from those participants who tolerated wearing the EEG cap.

Results: The difference in the change in CARS scores between the two groups was 7.23 (95% CI 2.357 to 12.107, p = 0.011). Seventeen of the thirty participants completed at least two EEGs and time-dependent trends were detected. In addition, an interaction between Active versus Sham and Scaled Time was observed in delta power (Coefficient = 7.521, 95% CI -0.517 to 15.559, p = 0.07) and theta power (Coefficient = -8.287, 95% CI -17.199 to 0.626, p = 0.07), indicating a potential trend towards a greater reduction in delta power and an increase in theta power over time with treatment in the Active group, compared to the Sham group. Furthermore, there was a significant difference in the condition (Treatment vs. Sham) in the power of theta waves (net_theta) (Coefficient = 9.547, 95% CI 0.027 to 19.067, p = 0.049). No moderate or severe side effects or adverse effects were reported or observed during the trial.

Conclusion: These results indicate that tPBM may be a safe and effective treatment for ASD and should be studied in more depth in larger studies.Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT04660552, identifier NCT04660552.

Keywords: ASD; EEG; PBM; autism; delta waves; pediatric neurology; tPBM.

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Conflict of interest statement

The authors declare that this study received funding from JelikaLite. The funder had the following involvement in the study: study design, data collection and analysis, decision to publish, and preparation of the manuscript. ES is a co-founder of JelikaLite and she holds equity in the company. LT is an employee and he holds equity in JelikaLite. WS is an employee of Vyir Technology.

Figures

Figure 1
Figure 1
Image of the Cognilum device providing tPBM treatment.
Figure 2
Figure 2
Flow diagram representing the screening and enrollment of the participants as well as the number of participants whose data was analyzed.
Figure 3
Figure 3
(A) Change of Delta for active condition over scaled time. Each dot represents each individual observation. The line is the regression line. X axis: scaled time. Y axis: power of delta. (B) Change of Delta for sham condition over scaled time. Each dot represents each individual observation. The line is the regression line. X axis: scaled time. Y axis: power of delta.
Figure 4
Figure 4
(A) Change of Theta for active condition over scaled time. Each dot represents each individual observation. The line is the regression line. X axis: scaled time. Y axis: power of Theta. (B) Change of Theta for sham condition over scaled time. Each dot represents each individual observation. The line is the regression line. X axis: scaled time. Y axis: power of Theta.
Figure 5
Figure 5
(A) Change of EEG Delta vs. Change in CARS. Each dot represents each individual observation. The line is the regression line. X axis: correlation of EEG Delta with time. Y axis: change in CARS. (B) Change of EEG Theta vs. Change in CARS. Each dot represents each individual observation. The line is the regression line. X axis: correlation of EEG Theta with time. Y axis: change in CARS. (C) Delta vs. Theta. X axis: correlation of delta with time. Each dot represents each individual observation. The line is the regression line. Y axis: correlation of theta with time.
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Associated data

Grants and funding

This work was supported by the Jelikalite Corp.