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Photobiomodulation on Core Symptoms of Autism

Efficacy of Photobiomodulation on Core Symptoms of Autism

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07542899
Enrollment
30
Registered
2026-04-21
Start date
2026-04-10
Completion date
2026-08-10
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism

Keywords

Light therapy, Brain stimulation., Non-invasive Therapy.

Brief summary

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.

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.

Interventions

DEVICEPhotobiomodulation

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

Sponsors

Suez University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Improvement in core symptoms of autismBaseline and after 3 months of interventionAssessment 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).
Improvement in sensory profileBaseline and after 3 months of interventionAssessment 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).

Contacts

CONTACTAya Salah Rostom, Lecturer
aya.rostom@the.suezuni.edu.eg+201065461772
STUDY_DIRECTORAlaa Mohammed Naguib, Lecturer

Cairo University

PRINCIPAL_INVESTIGATORMahmoud Usama Mahmoud, Lecturer

Cairo University

STUDY_CHAIRAhmed Mamdouh Tawfik, Lecturer

Cairo University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026