An Evaluation of Low Level Laser Light Therapy for Autistic Disorder

NCT03379662 | Completed Results FDA Device

• 1 other identifier: EC_AUT_001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Autistic Disorder

Keywords

Autism; Autistic Disorder; Autistic Spectrum Disorder; Irritability; laser; light therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 4 weeks (Study Endpoint)

Study Arms (2)

Erchonia HLS Laser

EXPERIMENTAL

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

Placebo Laser

PLACEBO COMPARATOR

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

Interventions

Erchonia HLS Laser DEVICE

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.

Erchonia HLS Laser

Placebo Laser DEVICE

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

Placebo Laser

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

Institute for Brain and Rehabilitation Sciences

Nazareth, 16470, Israel

Location

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Elvira Cawthon
• Organization: Regulatory Insight, Inc.

elvira@reginsight.com

6154475150

Study Officials

• Calixto Machado, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 20, 2017
• Study Start: July 2, 2017
• Primary Completion: October 28, 2017
• Study Completion: November 28, 2017
• Last Updated: May 27, 2021
• Results First Posted: May 27, 2021

Record last verified: 2021-05

Locations

IL (1)