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An Evaluation of Low Level Laser Light Therapy for Autistic Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03379662
Recruitment Status : Completed
First Posted : December 20, 2017
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation

Tracking Information
First Submitted Date  ICMJE December 15, 2017
First Posted Date  ICMJE December 20, 2017
Last Update Posted Date August 14, 2018
Actual Study Start Date  ICMJE July 2, 2017
Actual Primary Completion Date October 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2017)
Mean change from baseline to study endpoint in the Aberrant Behavior Checklist (ABC) Irritability & Agitation Subscale score. [ Time Frame: 4 weeks ]
Primary outcome measure in this study is defined as the mean change from baseline to study endpoint in the Aberrant Behavior Checklist (ABC) Irritability Subscale score. Study success will be established through the detection of a minimum mean difference of -8.5 points between test and placebo groups in the change in ABC Irritability Subscale score. The ABC is a 58-item symptom checklist for assessing and classifying problem behaviors of irritability and agitation; lethargy and social withdrawal, stereotypic behavior, hyperactivity and noncompliance; and inappropriate speech in children, adolescents and adults with developmental disorders. The higher the score, the worse the behavior.
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2017)
The primary efficacy outcome measure in this study is defined as the mean change from baseline to study endpoint in the Aberrant Behavior Checklist (ABC) Irritability & Agitation Subscale score. [ Time Frame: 4 weeks ]
Primary outcome measure in this study is defined as the mean change from baseline to study endpoint in the Aberrant Behavior Checklist (ABC) Irritability Subscale score. Study success will be established through the detection of a minimum mean difference of -8.5 points between test and placebo groups in the change in ABC Irritability Subscale score. The ABC is a 58-item symptom checklist for assessing and classifying problem behaviors of irritability and agitation; lethargy and social withdrawal, stereotypic behavior, hyperactivity and noncompliance; and inappropriate speech in children, adolescents and adults with developmental disorders. The higher the score, the worse the behavior.
Change History Complete list of historical versions of study NCT03379662 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Evaluation of Low Level Laser Light Therapy for Autistic Disorder
Official Title  ICMJE A Double-blind, Placebo-controlled Randomized Evaluation of the Effect of the Erchonia® HLS Laser Device on Children and Adolescents With Autistic Disorder
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autistic Disorder
Intervention  ICMJE
  • Device: 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.
  • Device: Placebo Laser
    The Placebo Laser emit the same visible light output as the active HLS Laser but without therapeutic effect.
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Device: Placebo Laser
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2017)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 28, 2017
Actual Primary Completion Date October 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female child or adolescent aged 5 to 17 years
  • Meets Diagnostic and Statistical Manual of Mental Disorders, 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 contraception throughout study participation.

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
  • HIV and other autoimmune 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 contraindication for, light therapy
  • Subject is presently pregnant or breast feeding
  • Participation in a research study within the past 30 days
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03379662
Other Study ID Numbers  ICMJE EC_AUT_001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erchonia Corporation
Study Sponsor  ICMJE Erchonia Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Calixto Machado, MD
PRS Account Erchonia Corporation
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP