An Evaluation of Low Level Laser Light Therapy for Autistic Disorder

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