Photobiomodulation on Core Symptoms of Autism

NCT07542899 | Not Yet Recruiting

• 1 other identifier: photobiomodulation on autism
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autism

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Photobiomodulation Group

EXPERIMENTAL

Device: Photobiomodulation

control group

NO INTERVENTION

Interventions

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

Photobiomodulation Group

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suez University: lead

MeSH Terms

Conditions

Autistic Disorder

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Alaa Mohammed Naguib, Lecturer

  Cairo University

  STUDY DIRECTOR

• Mahmoud Usama Mahmoud, Lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

• Ahmed Mamdouh Tawfik, Lecturer

  Cairo University

  STUDY CHAIR

Central Study Contacts

Aya Salah Rostom, Lecturer

CONTACT

+201065461772; aya.rostom@the.suezuni.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy for general surgery, Burn and skin, Suez university, Suez ,Egypt

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 21, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): August 10, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04