Status:
COMPLETED
An Evaluation of Low Level Laser Light Therapy for Autistic Disorder
Lead Sponsor:
Erchonia Corporation
Conditions:
Autistic Disorder
Eligibility:
All Genders
5-17 years
Phase:
NA
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 se...
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, communi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03379662
Start Date
July 2 2017
End Date
November 28 2017
Last Update
May 27 2021
Active Locations (1)
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1
Institute for Brain and Rehabilitation Sciences
Nazareth, Israel, 16470