The Effects of Photobiomodulation in children with autism: a randomized controlled clinical trial

INTERVENTION: The controlled and randomized clinical trial will include 160 children aged 3 to 12 years, with Autism Spectrum Disorder of different levels of severity who participate in the Program for Comprehensive Care for Children and Adolescents (PICA). Participants will be allocated by block randomization, into two groups: control group (CG) with a group of 32 children who will maintain the treatments they already undergo at PICA, and experimental group (GE) with 128 children who will receive treatment with Photobiomodulation (FBM) in addition to the treatments they already carry out. Children randomized to the EG will receive treatment with FBM, through the application of LASER AND LED, with technique and protocol as described below: A) Blood FBM Application (ILIB): The objective of this application is to promote vascular improvement, immunological and systemic anti‐inflammatory. The Red Laser, 660nm, 100 mW, will be used, applied punctually to the wrist region, over the pulsation of the radial artery. The irradiation time will be 15 min (in children up to 30 kg) or depending on their weight (time=weight/2). There will be 10 consecutive daily sessions, carried out by the mother/caregiver with the child sleeping. B) Transcranial FBM application will consist of protocols 1, 2, 3 and 4, the first 3 of which involve the application of FBM in 6 cortical regions: right and left prefrontal cortex, right and left temporal region, occipital region and parietal region. And 4 using a head‐worn device, a helmet, with simultaneous irradiation in different parts of the head. T1 Protocol. Red LED (650nm) and infrared (940nm) CW (continuous emission), with 6 red LEDs and 4 Infrared LEDs, 60 seconds each application, total power of 1W, with an area of 24cm2 of the applicator, 60 Joules per regi CONDITION: Autistic disorder PRIMARY OUTCOME: Global Functioning Assessment Scale. This scale will be used to verify the improvement in the level of severity of Autistic Aspect Disorder symptoms presented by the subjects of this research, in the version translated and validated into Brazilian Portuguese. The scale assesses behavior in 14 domains commonly affected in Autistic Aspect Disorder and has another category of “general impressions”. These 15 items include: personal relationships, imitation, emotional response, body use, use of objects, response to change, visual response, auditory response, response and use of taste, smell and touch, fear or nervousness, verbal communication, non‐ verbal, level of activity, level and consistency of intellectual response, and general impressions. The scores for each domain range from 1 (within normal limits) to 4 (severe autistic symptoms). The score varies from 15 to 60 and the cut‐off point for Autistic Aspect Disorder is 30, being applied before the beginning and two more times throughout the treatment. INCLUSION CRITERIA: Children aged between 3 and 12 years; both sexes; diagnosed with Autistic Spectrum Disorder, regardless of the degree of severity, gender, race, ethnicity or type of treatment they are undergoing SECONDARY OUTCOME: A Functional Communication Profile scale will be applied – Checklist, which is a list of communicative functions performed by children. Applied in the form of an interview, it indicates which of the 20 functions identified in the Functional Communication Profile the child uses, from the evaluator's point of view, taking into account the occurrence and the communicative means used. being applied before the beginning and for 2 more times throughout the treatment. A puncture will be made to remove a drop of blood and immediate analysis in dark field microscopy with the collection of images referring to the behavior of erythrocytes and other blood components for later evaluation. The evaluations will be made before the beginning of the treatment and for another 4 times, once during the treatment, another at the end of the Photobiomodulation cycle and two more after 3 and 6 months of the end of the treatment. Parents will be asked to collect a sample of the child's stool and send it for microbiological analysis before the start, after the application of the blood Photobiomodulation and after the application of the Transcranial + abdominal FBM for parasitological analysis. The Autism Treatment Evaluation Checklist scale will be applied, which was specifically designed to measure changes in the severity of Autism spectrum disorder, making it useful for monitoring behaviors over time, as well as tracking the effectiveness of a treatment. The Autism Treatment Evaluation Checklist is composed of four subscales: (1) Speech / Language / Communication, (2) Sociability, (3) Sensory / Cognitive Sensitivity, and (4) Health / Physicality / Behavior. Subscales provide researchers with information about specific areas of behavior that may change over time. Higher scores indicate more problems in each domain. The total score can vary from 0 to 179. It will be performed before the intervention, soon after, three and si Xmonths after the end of the treatment. The Questionnaire to assess the quality of life of caregivers of children and adolescents with Autism spectrum disorder and Sociodemographic Profile will be applied, containing ten sociodemographic questions followed by 28 questions about quality of life. This questionnaire was developed and validated for the Brazilian population and uses a five‐point Likert scale, with a total of 28 questions about the quality of life of caregivers of children and adolescents with Autism spectrum disorder. being applied before the beginning and for 2 more times throughout the treatment.