Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Evaluation of Low Level Laser Light Therapy for Autistic Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03379662
Recruitment Status : Completed
First Posted : December 20, 2017
Results First Posted : May 27, 2021
Last Update Posted : May 27, 2021
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Autistic Disorder
Interventions Device: Erchonia HLS Laser
Device: Placebo Laser
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Erchonia HLS Laser Placebo Laser
Hide Arm/Group Description

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.

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.

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.

Placebo Laser: The Placebo Laser emit the same visible light output as the active HLS Laser but without therapeutic effect.

Period Title: Overall Study
Started 21 19
Completed 21 19
Not Completed 0 0
Arm/Group Title Erchonia HLS Laser Placebo Laser Total
Hide Arm/Group Description

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.

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.

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.

Placebo Laser: The Placebo Laser emit the same visible light output as the active HLS Laser but without therapeutic effect.

Total of all reporting groups
Overall Number of Baseline Participants 21 19 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 19 participants 40 participants
8.24  (3.02) 8.37  (3.15) 8.29  (3.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
Female
5
  23.8%
5
  26.3%
10
  25.0%
Male
16
  76.2%
14
  73.7%
30
  75.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
American Indian or Alaska Native
0
   0.0%
1
   5.3%
1
   2.5%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  38.1%
12
  63.2%
20
  50.0%
White
12
  57.1%
4
  21.1%
16
  40.0%
More than one race
1
   4.8%
2
  10.5%
3
   7.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Cuba Number Analyzed 21 participants 19 participants 40 participants
21 19 40
Baseline Aberrant Behavior Checklist (ABC) Irritability Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 21 participants 19 participants 40 participants
30.52  (15.71) 29.58  (28.89) 30.04  (22.65)
[1]
Measure Description: The ABC Irritability Subscale includes questions about aggression, self-injury, tantrums, agitation and unstable mood on a scale of 0 to 45, with higher scores indicating greater severity. Data from studies of developmentally disabled children indicated that a score of 18 is 1.3 to 1.5 SD above the population means, depending on the age and sex of the child.
1.Primary Outcome
Title Mean Change From Baseline to Study Endpoint in the Aberrant Behavior Checklist (ABC) Irritability & Agitation Subscale Score.
Hide Description 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.
Time Frame Baseline and 4 weeks (Study Endpoint)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia HLS Laser Placebo Laser
Hide Arm/Group Description:

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.

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.

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.

Placebo Laser: The Placebo Laser emit the same visible light output as the active HLS Laser but without therapeutic effect.

Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: score on a scale
-14.81  (6.40) 0.37  (1.38)
Time Frame 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erchonia HLS Laser Placebo Laser
Hide Arm/Group Description

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.

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.

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.

Placebo Laser: The Placebo Laser emit the same visible light output as the active HLS Laser but without therapeutic effect.

All-Cause Mortality
Erchonia HLS Laser Placebo Laser
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/19 (0.00%) 
Hide Serious Adverse Events
Erchonia HLS Laser Placebo Laser
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/19 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Erchonia HLS Laser Placebo Laser
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/19 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elvira Cawthon
Organization: Regulatory Insight, Inc.
Phone: 6154475150
EMail: elvira@reginsight.com
Layout table for additonal information
Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT03379662    
Other Study ID Numbers: EC_AUT_001
First Submitted: December 15, 2017
First Posted: December 20, 2017
Results First Submitted: January 26, 2020
Results First Posted: May 27, 2021
Last Update Posted: May 27, 2021