Photobiomodulation on Core Symptoms of Autism

Efficacy of Photobiomodulation on Core Symptoms of Autism

This study aims to evaluate the effectiveness of photobiomodulation therapy on core symptoms in children with autism spectrum disorder. Participants will receive designed physical therapy, occupational therapy and speech program in addition to Photobiomodulation over a defined period. Out comes will be assessed using standardized clinical scales to determine improvements in social interactions, communication and behavior.

Study Overview

• Status: Not yet recruiting
• Conditions: Autism
• Intervention / Treatment: Device: Photobiomodulation

Detailed Description

Autism spectrum disorder (ASD) is a complex neurodevelopmental condition typically characterized by social and communicative problems as well as repetitive patterns of behaviour. Photobiomodulation is non-invasive exposure of light, typically within the red to near-infrared spectrum, to elicit physiological effects across several tissue systems. This study is designed as a randomized controlled trial to assess the effect of Photobiomodulation on core symptoms of autism spectrum disorder. Participants will be recruited from outpatient clinic of faculty of physical therapy at Cairo University. The intervention protocol includes that the child is in supine lying position with eyes covered with sheet. Each participant started with a 2 min treatment. Participants who tolerated the treatment well received incrementally larger doses (2 min) in each of 5 subsequent sessions, for a maximum dose of 12 min. Two groups of children each received a random assignment. after being selected from outpatient clinic of faculty of physical therapy. Both groups (A and B) participated in physical treatment for three months; group A had designed physical therapy, occupational therapy and speech program, whereas group B had the same designed physical therapy, occupational therapy and speech program in addition to Photobiomodulation.

Ethical considerations:

This study has been reviewed and approved by Institutional Review Board / Ethics Committee via the Faculty of Physical Therapy Research Ethics Officer. Written informed consent will be obtained from all participants before enrollment.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aya Salah Rostom, Lecturer; Phone Number: +201065461772; Email: aya.rostom@the.suezuni.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Children with autism spectrum disorders (ASD).
2. Their age ranged from 2 to 6 years

Exclusion Criteria:

1. Children having epileptogenic seizures.
2. Mentally retarded children.
3. Children with genetic syndromes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Experimental: Photobiomodulation Group	Device: Photobiomodulation; non-invasive exposure of light, typically within the red to near-infrared (~λ = 600-1300 nm) spectrum, to elicit physiological effects across several tissue systems. The application will be transcranial with distance of 50 cm above the head. The child is in supine lying position with eyes covered with sheet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in core symptoms of autism	Assessment of changes in core autism symptoms using the Childhood Autism Rating Scale.The scale ranges from 15 to 60 , with higher scores indicating more severe autism symptoms (worse out come).	Baseline and after 3 months of intervention
Improvement in sensory profile	Assessment of a child's sensory processing patterns using the Sensory Profile 2. The Sensory Profile 2 is a standardized caregiver questionnaire that evaluates sensory processing across multiple domains. Scores are categorized into performance ranges (e.g., "Much Less Than Others", "Less Than Others," Just Like the Majority of Others," "More Than Others," "Much More Than Others") , with deviations from the typical range indicating greater sensory processing difficulties (worse outcome).	Baseline and after 3 months of intervention

Collaborators and Investigators

• Sponsor: Suez University
• Investigators: Study Director: Alaa Mohammed Naguib, Lecturer, Cairo University; Principal Investigator: Mahmoud Usama Mahmoud, Lecturer, Cairo University; Study Chair: Ahmed Mamdouh Tawfik, Lecturer, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2026
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): August 10, 2026

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Light therapy; Brain stimulation.; Non-invasive Therapy.
• Additional Relevant MeSH Terms: Autism Spectrum Disorder; Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Therapeutics; Laser Therapy; Phototherapy; Low-Level Light Therapy
• Other Study ID Numbers: photobiomodulation on autism

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No