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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

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.

Condition or disease Intervention/treatment Phase
Autistic Disorder Device: Erchonia HLS Laser Device: Placebo Laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Randomized Evaluation of the Effect of the Erchonia® HLS Laser Device on Children and Adolescents With Autistic Disorder
Actual Study Start Date : July 2, 2017
Actual Primary Completion Date : October 28, 2017
Actual Study Completion Date : November 28, 2017

Arm Intervention/treatment
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
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.

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




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379662


Locations
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Israel
Institute for Brain and Rehabilitation Sciences
Nazareth, Israel, 16470
Sponsors and Collaborators
Erchonia Corporation
Investigators
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Principal Investigator: Calixto Machado, MD

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Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT03379662    
Other Study ID Numbers: EC_AUT_001
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

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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
Keywords provided by Erchonia Corporation:
Autism
Autistic Disorder
Autistic Spectrum Disorder
Irritability
laser
light therapy
Additional relevant MeSH terms:
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Disease
Autistic Disorder
Pathologic Processes
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders