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Trial Outcomes & Findings for An Evaluation of Low Level Laser Light Therapy for Autistic Disorder (NCT NCT03379662)

NCT ID: NCT03379662

Last Updated: 2021-05-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Baseline and 4 weeks (Study Endpoint)

Results posted on

2021-05-27

Participant Flow

Participant milestones

Participant milestones
Measure
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. 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 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. Placebo Laser: The Placebo Laser emit the same visible light output as the active HLS Laser but without therapeutic effect.
Overall Study
STARTED
21
19
Overall Study
COMPLETED
21
19
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Evaluation of Low Level Laser Light Therapy for Autistic Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Erchonia HLS Laser
n=21 Participants
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.
Placebo Laser
n=19 Participants
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
n=40 Participants
Total of all reporting groups
Age, Continuous
8.24 years
STANDARD_DEVIATION 3.02 • n=93 Participants
8.37 years
STANDARD_DEVIATION 3.15 • n=4 Participants
8.29 years
STANDARD_DEVIATION 3.07 • n=27 Participants
Sex: Female, Male
Female
5 Participants
n=93 Participants
5 Participants
n=4 Participants
10 Participants
n=27 Participants
Sex: Female, Male
Male
16 Participants
n=93 Participants
14 Participants
n=4 Participants
30 Participants
n=27 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
1 Participants
n=4 Participants
1 Participants
n=27 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Black or African American
8 Participants
n=93 Participants
12 Participants
n=4 Participants
20 Participants
n=27 Participants
Race (NIH/OMB)
White
12 Participants
n=93 Participants
4 Participants
n=4 Participants
16 Participants
n=27 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=93 Participants
2 Participants
n=4 Participants
3 Participants
n=27 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Region of Enrollment
Cuba
21 participants
n=93 Participants
19 participants
n=4 Participants
40 participants
n=27 Participants
Baseline Aberrant Behavior Checklist (ABC) Irritability Score
30.52 score on a scale
STANDARD_DEVIATION 15.71 • n=93 Participants
29.58 score on a scale
STANDARD_DEVIATION 28.89 • n=4 Participants
30.04 score on a scale
STANDARD_DEVIATION 22.65 • n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Erchonia HLS Laser
n=21 Participants
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.
Placebo Laser
n=19 Participants
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.
Mean Change From Baseline to Study Endpoint in the Aberrant Behavior Checklist (ABC) Irritability & Agitation Subscale Score.
-14.81 score on a scale
Standard Deviation 6.40
0.37 score on a scale
Standard Deviation 1.38

Adverse Events

Erchonia HLS Laser

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo Laser

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elvira Cawthon

Regulatory Insight, Inc.

Phone: 6154475150

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place