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
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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.
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.
1,033 studies on the registry are indexed under Autistic Disorder; 269 are open to participants now.
Browse Autistic Disorder studies →4 of the 22 studies in Autistic Disorder with a site in Israel are open now. Recruiting first, the newest first:
Prof. Adi Aran · Sites in Israel
Ages 3–6
Bazelet Nehushtan LtD. · Sites in Israel
Ages 4–13
Meir Medical Center · Sites in Israel
Ages 30–80 · Healthy volunteers
Benjamin Gesundheit · Sites in Israel
Ages 10 mo–19 yrs · Healthy volunteers
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 →
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.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 7 · Phase 3 1 · Phase 4 1
First in 2007; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 40 is below the median of 49 across 813 interventional studies indexed under Autistic Disorder.
Median enrollment 50 across the 14 interventional studies, 350 across the 8 observational. Of the 9 that completed or were terminated, 1 (11%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 22 have an industry lead sponsor. The 10 most frequent:
Erchonia Corporation is the lead sponsor of 48 studies on the registry; 2 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.
Erchonia Corporation has 2 studies filed under Autistic Disorder — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 22 studies in Autistic Disorder with a site in Israel, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
Exclusion Criteria:
Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS); Asperger's Disorder; Rett's Disorder; Fragile-X Syndrome; Childhood Disintegrative Disorder; Down Syndrome
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.
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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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 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.
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)
| Milestone | Erchonia HLS Laser | Placebo Laser |
|---|---|---|
| Started | 21 | 19 |
| Completed | 21 | 19 |
| Not completed | 0 | 0 |
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.
| score on a scale | Erchonia HLS Laser | Placebo Laser |
|---|---|---|
| Mean Change From Baseline to Study Endpoint in the Aberrant Behavior Checklist (ABC) Irritability & Agitation Subscale Score. | -14.81 ± 6.40 | 0.37 ± 1.38 |
Collected over 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Erchonia HLS Laser | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Placebo Laser | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Continuous(years) | Erchonia HLS Laser | Placebo Laser | Total |
|---|---|---|---|
| Mean | 8.24 ± 3.02 | 8.37 ± 3.15 | 8.29 ± 3.07 |
| Sex: Female, Male(Participants) | Erchonia HLS Laser | Placebo Laser | Total |
|---|---|---|---|
| Female | 5 | 5 | 10 |
| Male | 16 | 14 | 30 |
| Race (NIH/OMB)(Participants) | Erchonia HLS Laser | Placebo Laser | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 12 | 20 |
| White | 12 | 4 | 16 |
| More than one race | 1 | 2 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Erchonia HLS Laser | Placebo Laser | Total |
|---|---|---|---|
| Cuba | 21 | 19 | 40 |
| Baseline Aberrant Behavior Checklist (ABC) Irritability Score(score on a scale) | Erchonia HLS Laser | Placebo Laser | Total |
|---|---|---|---|
| Mean | 30.52 ± 15.71 | 29.58 ± 28.89 | 30.04 ± 22.65 |
PDFs hosted by the registry, ClinicalTrials.gov.
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.
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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