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NCT Number: NCT07542899

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.

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Key information

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Children having epileptogenic seizures.
  • Mentally retarded children.
  • Children with genetic syndromes.

Treatment and study plan

Photobiomodulation

Device

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

Primary outcomes

  1. Improvement in core symptoms of autism

    Time frame: Baseline and after 3 months of intervention

    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).

  2. Improvement in sensory profile

    Time frame: Baseline and after 3 months of intervention

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Aya Salah Rostom, Lecturer

CONTACT

[email protected]

+201065461772

Sponsors and collaborators

Lead sponsor

Suez University

Other

Registry information

Official study title

Efficacy of Photobiomodulation on Core Symptoms of Autism

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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