An Evaluation of Low Level Laser Light Therapy for Autistic Disorder 2
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional

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 twelve (12) years.
    

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.
    

Intervention name(s): Erchonia HLS Laser; Placebo Laser
Intervention type(s): Device; Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Autistic Disorder; Irritability; laser; light therapy