An Evaluation of Low Level Laser Light Therapy for Autistic Disorder
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|ClinicalTrials.gov Identifier: NCT03379662|
Recruitment Status : Completed
First Posted : December 20, 2017
Results First Posted : May 27, 2021
Last Update Posted : May 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Autistic Disorder||Device: Erchonia HLS Laser Device: Placebo Laser||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Placebo-controlled Randomized Evaluation of the Effect of the Erchonia® HLS Laser Device on Children and Adolescents With Autistic Disorder|
|Actual Study Start Date :||July 2, 2017|
|Actual Primary Completion Date :||October 28, 2017|
|Actual Study Completion Date :||November 28, 2017|
Experimental: Erchonia HLS Laser
The Erchonia HLS Laser is administered 8 times across 4 weeks for 5 minutes each time to the skull at the base of the brain and temporal areas.
Device: Erchonia HLS Laser
The Erchonia HLS Laser emits a 640 nm (nanometer) wavelength with a tolerance of ±10 nm from each of two 7.5 mw (milliwatt) laser diodes.
Placebo Comparator: Placebo Laser
The Placebo Laser is administered 8 times across 4 weeks for 5 minutes each time to the skull at the base of the brain and temporal areas.
Device: Placebo Laser
The Placebo Laser emit the same visible light output as the active HLS Laser but without therapeutic effect.
- Mean Change From Baseline to Study Endpoint in the Aberrant Behavior Checklist (ABC) Irritability & Agitation Subscale Score. [ Time Frame: Baseline and 4 weeks (Study Endpoint) ]Primary outcome measure in this study is defined as the mean change from baseline to 4 weeks of intervention (study endpoint), in the Aberrant Behavior Checklist (ABC) Irritability Subscale score. The ABC Irritability Subscale contains 15 items relating to aggression, self-injury, tantrums, agitation and unstable mood in individuals with developmental disorders. Each item is rated from 0 (not at all a problem) to 3 (the problem is severe in degree). The individual scores are summed for a total score from 0 to 45, with higher scores indicating greater severity. A negative (-) change indicates a decrease in symptom severity and is positive for improvement. A positive (+) change indicates an increase in symptom severity and is negative for improvement. Study success is established as the detection of a minimum mean difference of -8.5 points between test and placebo groups in the change in ABC Irritability Subscale score.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379662
|Institute for Brain and Rehabilitation Sciences|
|Nazareth, Israel, 16470|
|Principal Investigator:||Calixto Machado, MD|