AutismNCT07542899
Photobiomodulation on Core Symptoms of Autism
A study testing Photobiomodulation in people with Autism, run by Suez University.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Autism
- What is being tested?
- Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2026to 10 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with autism spectrum disorders (ASD).
- Their age ranged from 2 to 6 years
Who cannot join
- Children having epileptogenic seizures.
- Mentally retarded children.
- Children with genetic syndromes.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism
- Being tested
- Photobiomodulation
- Keywords
- Light therapy, Brain stimulation., Non-invasive Therapy.
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation Group | Experimental | Not described Receives: Device: Photobiomodulation |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline and after 3 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion10 Jul 2026 (estimated)
- Study completion10 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya salah el din fouad rostom, Suez University
- Investigators
- Alaa Mohammed Naguib, Lecturer, Study director, Cairo UniversityMahmoud Usama Mahmoud, Lecturer, Principal investigator, Cairo UniversityAhmed Mamdouh Tawfik, Lecturer, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542899
- Sponsor's protocol ID
- photobiomodulation on autism
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Photobiomodulation on Core Symptoms of Autism
- ClinicalTrials.gov ID
- NCT07542899
- Acronym / sponsor ID
- photobiomodulation on autism
- Conditions
- Autism
- Keywords
- Light therapy, Brain stimulation., Non-invasive Therapy.
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Suez UniversityUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 10 Aug 2026 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation Group | Experimental | Device: Photobiomodulation |
| control group | No intervention | – |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with autism spectrum disorders (ASD).
- Their age ranged from 2 to 6 years
Key exclusion criteria (3 listed)
- Children having epileptogenic seizures.
- Mentally retarded children.
- Children with genetic syndromes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulationnon-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 | Device | Photobiomodulation Group |
Primary outcome
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alaa Mohammed Naguib, Lecturer study director
Cairo University
Mahmoud Usama Mahmoud, Lecturer principal investigator
Cairo University
Ahmed Mamdouh Tawfik, Lecturer study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Autism, run by Suez University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya Salah Rostom, Lecturer (+201065461772, aya.rostom@the.suezuni.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in core symptoms of autism (time frame: Baseline and after 3 months of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.