An Evaluation of Low Level Laser Light Therapy for Autistic Disorder 2

NCT04895605 | Completed Results

• 1 other identifier: EC_AUT_USA
• 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 twelve (12) years.

Conditions

Autistic Disorder

Keywords

Autism; Autistic 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 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.

  4 weeks

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

You may qualify if:

• Male or female child or adolescent aged 5 to 12 years
• Subject has met Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) 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)
• Subject demonstrates 'irritable' behaviors such as tantrums, aggression, self-injurious behavior, or a combination of such behaviors
• Subject's Aberrant Behavior Checklist (ABC) Irritability Subscale score is \>=18
• Subject's Clinical Global Impressions - Severity (CGI-S) scale score is \>=4 (4=moderately ill)
• Subject's current therapeutic/intervention plan for treating his or her autistic disorder (educational/behavioral or other therapy; medication use; dietary interventions) has been consistent/stable over at least the past 3 months and the subject's caregiver agrees, and it is possible for, the subject to maintain his or her current therapeutic/intervention plan throughout participation in the clinical study.
• Subject's caregiver agrees, and it is possible for, the subject to abstain from partaking in new treatments to treat the subject's autistic disorder symptoms during participation in the study. This includes educational/behavioral therapy, dietary interventions, medications such as FDA-approved Risperdal® and Abilify® and other medications often prescribed for the treatment of other autism-related symptoms, such as anxiety, depression, or obsessive-compulsive disorder, including antipsychotic medications used to treat severe behavioral problem, and medications used to treat people with attention deficit disorder

You may not qualify if:

• Subject has a primary or concurrent diagnosis of another disorder or other identifiable genetic condition associated with the autism spectrum scale or with mental retardation, including:
• 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
• 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 arrhythmia (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

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

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

elvira@reginsight.com

6154475150

Publication Agreements

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

Study Design

• Study Type: interventional
• 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: May 17, 2021
• First Posted: May 20, 2021
• Study Start: November 11, 2020
• Primary Completion: February 17, 2022
• Study Completion: March 17, 2022
• Last Updated: August 30, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-08

Locations

US (1)