Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03379662 |
| Other study ID # |
EC_AUT_001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2, 2017 |
| Est. completion date |
November 28, 2017 |
Study information
| Verified date |
May 2021 |
| Source |
Erchonia Corporation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
