ClinicalTrials.gg
CompletedNCT03379662Updated May 27, 2021Results posted

An Evaluation of Low Level Laser Light Therapy for Autistic Disorder

An interventional study of Erchonia HLS Laser and Placebo Laser in Autistic Disorder, sponsored by Erchonia Corporation. Completed at 1 site in Israel. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-05-27.

Sponsored by Erchonia Corporation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jul 2017, registered Dec 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
5 Years to 17 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 22 studies in Autistic Disorder with a site in Israel — 4 open to participants now, 4 under way, none of them phase 3. Autistic Disorder · Israel.

Enrollment
10th of 14
40 · median 50
Started
2017
with 1 other
No phase
5 of 22
1 open now
Registered
15th of 22
by date
Lead sponsor
1 of 22
Erchonia Corporation

Among the 22 studies in Autistic Disorder with a site in Israel, this one is the 10th largest by enrollment of the 14 interventional ones that give a count, is one of 2 that started in 2017, is one of 5 with no phase, and was the 15th registered.

Autistic Disorder

1,033 studies on the registry are indexed under Autistic Disorder; 269 are open to participants now.

Browse Autistic Disorder studies →

Open to participants now

4 of the 22 studies in Autistic Disorder with a site in Israel are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Israel have not opened yet or have stopped. Only those recruiting at a site in Israel →

Who these studies take

Of the 183 Autistic Disorder studies recruiting now, 33 (18%) set no upper age limit and 143 (78%) stop at 75 or younger; 148 take children under 18; 56 take healthy volunteers.

This study: 5 Years to 17 Years · all sexes · no healthy volunteers.

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02

Study summary

The purpose of this study is to determine whether the Erchonia HLS Laser is effective in the treatment of irritability associated with autistic disorder in children and adolescents aged five (5) to seventeen (17) years.

Read the detailed description

Autism spectrum disorder (ASD) is a range of complex neurodevelopment disorders characterized by behavioral, developmental, cognitive and psychological deficits that include social impairment, communication and language difficulties, hyperactivity, irritability, obsessive interests and restricted, and repetitive behaviors. Autistic disorder, sometimes called autism or classical ASD, is the most severe form of ASD. ASD occurs in all ethnic and socioeconomic groups and affects every age group, with symptoms appearing before age 3. The Centers for Disease Control (CDC) estimates that 1 out of 88 children age 8 will have an ASD, with males four times more likely to have an ASD than females.

There is no cure for ASD and no single best treatment for all individuals with autistic disorder. The majority of diagnosed cases of autism are idiopathic with an enigmatic pathogenesis, and as a result, therapeutic approaches have focused on mitigating specific symptoms rather than treating disease etiologies. The current standard treatment approach is a team approach to customize an individual highly structured, specialized program or treatment plan including medications, therapies and behavioral interventions targeted toward improving the individual's specific symptoms.

The cause of ASD is not clearly understood, but it is believed that both genetics and environment likely play a role. Magnetic resonance imaging (MRI) studies have demonstrated increased brain volume and head circumference during early developmental childhood, suggesting that autistic brains experience a period a rapid overgrowth which hampers further development during later developmental stages. Morphological aberrations have been observed in the hippocampus, anterior cingulate cortex, prefrontal cortex, amygdala, and cerebellum. Another consistent observation has also been the reduction in cerebellar vermis volume, which helps to explain specific behavioral patterns in children.

Molecular analysis of postmortem brain tissue has revealed reduced Purkinje cell numbers, which helps to explain aberrant locomotive activity and level presser function. Another finding has been impaired neuronal connectivity within the cerebellum, amygdala, anterior cingulate cortex, and dorsolateral prefrontal cortex. As a consequence, synapse structure and function has demonstrated impairment in postmortem evaluations. Dendritic spines of glutamatergic neurons in autistic patients have shown morphological alterations and suppressed density, which, in turn, results in diminished synaptic transmissions. Nascent spines have been reported in frontal, temporal, and parietal cortices of autistic patients, and have a negative correlation with cognitive abilities in autism. Other neurological aberrations include signaling through metabotropic glutamate receptor (mGluR) and ƴ-aminobutyric acid (GABA)ergic system.

The elusive pathophysiology of autism provides a marked challenge for health care providers. One promising technology is low-level laser therapy (LLLT). LLLT uses photonic energy to modulate the behavior and function of cells by stimulating molecular entities capable of absorbing discrete wavelengths. or instance, cytochrome c oxidase (CCO), a terminal enzyme of the respiratory change, contains a tetrapyrrole prosthetic group that has been shown to absorb 635nm. Photon-induced activation of CCO increases cell bioenergetics, which, in turn, activates intra-cellular secondary signaling cascades that in turn affect growth factor synthesis, cell proliferation, cytokine production, and expression of specific transcription factors. Studies have reported increased adenosine triphosphate (ATP) synthesis along with activation of the intracellular redox state following the production of reactive oxygen species (ROS). As an essential bio-catalyst, ATP lowers the activation for pivotal biochemical reactions within cells. Concerning neurons, laser irradiation has been shown to promote the recovery of injured peripheral nerves and the spinal cord. Moreover, studies have revealed that excitable cells like neurons can be directly stimulated by light, enhancing the action potential of the cell increasing the release of neurotransmitters such as glutamate and acetylcholine.

Clinical outcomes with LLLT trials include nerve regeneration, increased neurotransmitter release, growth factor synthesis, and neovascularization to name a few. It follows that positioning of the laser along impaired regions of an autistic brain could elicit a positive therapeutic outcome in a safe and non-invasive manner.

03

Conditions studied

  • Autistic Disorder

Keywords

  • Autism
  • Autistic Disorder
  • Autistic Spectrum Disorder
  • Irritability
  • laser
  • light therapy
04

Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female child or adolescent aged 5 to 17 years
  • Meets , 4th Edition, Text Revision criteria (DSM-IV-TR) for autistic disorder within the past 2 years, as diagnosed by a trained, qualified medical professional such as a pediatric neurologist, child psychiatrist or developmental pediatrician
  • Diagnosis is confirmed by Autism Diagnostic Interview (ADI-R)
  • Demonstrates 'irritable' behaviors such as tantrums, aggression, self-injurious behavior, or a combination of such behaviors
  • Aberrant Behavior Checklist (ABC) Irritability Subscale score is >=18
  • Clinical Global Impressions - Severity (CGI-S) scale score is >=4 (moderately ill)
  • Current therapeutic/intervention plan for treating autistic disorder has been consistent/ stable over at least the past 3 months
  • Caregiver agrees, and it is possible for, the subject to abstain from partaking in new treatments to treat autistic disorder symptoms during the course of study participation
  • Female subjects of child-bearing age are willing and able to use acceptable means of throughout study participation.

Exclusion criteria

Exclusion Criteria:

  • Primary or concurrent diagnosis of another disorder or other identifiable genetic condition associated with the autism spectrum scale or with mental retardation, including:

Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS); Asperger's Disorder; Rett's Disorder; Fragile-X Syndrome; Childhood Disintegrative Disorder; Down Syndrome

  • Seizure disorders (active), cerebrovascular disease or brain trauma as etiology of autistic behavior
  • Current diagnosis of, and treatment for, bipolar disorder, psychosis, schizophrenia, or major depression
  • Current use of a psychotropic drug deemed effective for the treatment of aggression, tantrums or self-injurious behavior
  • Known neurological disease, such as encephalitis
  • Significant sensory or motor impairment such as cerebral palsy
  • Diagnosis of epilepsy that is currently treated with anti-convulsant medication
  • Previous significant head trauma
  • Hearing loss requiring use of assistive devices such as hearing aids or cochlear implant
  • Significant visual impairment that cannot be adequately corrected with lenses
  • Documented mental age younger than 18 months
  • and other disorders
  • Active cancer or treatment for cancer within last 6 months
  • Unstable cardiac disease, such as a recent cardiac arrhythmias (including atrial fibrillation, ventricular fibrillation and irregular atrial-ventricular conduction time), or recent congestive heart failure, or recent myocardial infarction
  • Previous surgical interventions to the head/neck area
  • Sensitivity to, or for, light therapy
  • Subject is presently pregnant or breast feeding
  • Participation in a research study within the past 30 days
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceErchonia 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.

  • DevicePlacebo Laser

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

06

What researchers measure

Primary outcomes

  1. Mean Change From Baseline to Study Endpoint in the Aberrant Behavior Checklist (ABC) Irritability & Agitation Subscale Score.

    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)

07

Results

Posted May 27, 2021

Participant flow

Participant flow — Overall Study
MilestoneErchonia HLS LaserPlacebo Laser
Started2119
Completed2119
Not completed00

Outcome measures

PrimaryMean Change From Baseline to Study Endpoint in the Aberrant Behavior Checklist (ABC) Irritability & Agitation Subscale Score.

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)
Reported as:
Mean · score on a scale
Mean Change From Baseline to Study Endpoint in the Aberrant Behavior Checklist (ABC) Irritability & Agitation Subscale Score.
score on a scaleErchonia HLS LaserPlacebo Laser
Mean Change From Baseline to Study Endpoint in the Aberrant Behavior Checklist (ABC) Irritability & Agitation Subscale Score.-14.81 ± 6.400.37 ± 1.38

Adverse events

Collected over 4 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Erchonia HLS Laser0/21 (0%)0/21 (0%)0/21 (0%)
Placebo Laser0/19 (0%)0/19 (0%)0/19 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Erchonia HLS LaserPlacebo LaserTotal
Mean8.24 ± 3.028.37 ± 3.158.29 ± 3.07
Sex: Female, Male
Sex: Female, Male(Participants)Erchonia HLS LaserPlacebo LaserTotal
Female5510
Male161430
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Erchonia HLS LaserPlacebo LaserTotal
American Indian or Alaska Native011
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American81220
White12416
More than one race123
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Erchonia HLS LaserPlacebo LaserTotal
Cuba211940
Baseline Aberrant Behavior Checklist (ABC) Irritability Score
Baseline Aberrant Behavior Checklist (ABC) Irritability Score(score on a scale)Erchonia HLS LaserPlacebo LaserTotal
Mean30.52 ± 15.7129.58 ± 28.8930.04 ± 22.65
08

Study locations

1 site
  • Institute for Brain and Rehabilitation Sciences
    Nazareth, 16470, Israel
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2017 to primary completion in Oct 2017, 3 months.

Results were first posted in May 2021, 3 years 6 months after primary completion.

Of 367 interventional studies with no phase under Autistic Disorder, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 15, 2017
First posted
Dec 20, 2017
StartActual
Jul 2, 2017
Primary completionActual
Oct 28, 2017
CompletionActual
Nov 28, 2017
Results first posted
May 27, 2021
Last update
May 27, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03379662
Responsible party
Sponsor
First posted
Dec 20, 2017
Start date
Jul 2, 2017
Primary completion
Oct 28, 2017
Completion
Nov 28, 2017
Results posted
May 27, 2021
Last update
May 27, 2021

Study contacts

Calixto Machado, MD
principal investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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