| CTRI Number |
CTRI/2026/02/102678 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
31/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of integrating transcranial photobiomodulation with occupational therapy intervention in children with Autism spectrum disorder |
|
Scientific Title of Study
|
Effects of Integrating Transcranial photobiomodulation with Occupational Therapy Intervention on Executive Functions, Sensory Processing and Symptom Profile in Children with Autism Spectrum Disorder - A Randomized Controlled Trial |
| Trial Acronym |
ASD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anitha A |
| Designation |
Master of occupational therapy in paediatrics student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri ramachandra faculty of occupational therapy No:1 Ramachandra nagar porur chennai 600116 Tamil Nadu India
Sri ramachandra faculty of occupational therapy
No:1 Ramachandra nagar porur chennai 600116 Tamil Nadu India
Chennai
TAMIL NADU
600116
India |
| Phone |
9342796799 |
| Fax |
|
| Email |
anithaot2203@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raghuram P |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri ramachandra faculty of occupational therapy
no:1 ramachandra nagar , porur, chennai 600116, Tamil Nadu
Sri ramachandra faculty of occupational therapy
No:1, Ramachandra nagar, porur, chennai - 600116, Tamil Nadu, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
9677073853 |
| Fax |
|
| Email |
raghurammot@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Raghuram P |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri ramachandra faculty of occupational therapy
no: 1 ramachandra nagar , porur, chennai 600116, Tamil Nadu
Sri ramachandra faculty of occupational therapy
No:1, Ramachandra nagar, porur, chennai - 600116, Tamil Nadu, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
9677073853 |
| Fax |
|
| Email |
raghurammot@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| The device is sponsored by vielight - canadian company |
|
|
Primary Sponsor
|
| Name |
Anitha. A |
| Address |
No 1 sri ramachandra institute of higher education and research porur chennai 600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| EEG cost is supported by sri ramachandra institute of higher education and research |
No: 1 sri ramachandra institute of higher education and research porur chennai 600116 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anitha A |
Sri ramachandra hospital and vidhya sudha in porur |
sri ramachandra faculty of occupational therapy
No: 10 ramachandra nagar porur chennai 600116
Chennai
TAMIL NADU |
9342796799
anithaot2203@gmail.com |
| Anitha A |
Sri ramachandra hospital porur and vidhya sudha |
Sri ramachandra Institute of Higher Education and Research,
No:1 Ramachandra nagar porur chennai - 600116, Tamil Nadu, India
Chennai
TAMIL NADU |
9342796799
anithaot2203@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri ramachandra Institute of Higher Education and Research, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional occupational therapy intervention |
Activities for improving Executive function, regulating Sensory processing and reduce symptom severity in ASD children 18 session for each participants 9 weeks protocol weekly twice the session 45 minutes of conventional occupational therapy intervention the total study duration is 3 months |
| Intervention |
Transcranial photobiomodulation with occupational therapy intervention |
18 session for each participants 9 weeks protocol weekly twice the session transcranial photobiomodulation for 5 minutes and along with 40 minutes of conventional occupational therapy intervention the total study duration is 3 months |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Participants who scored moderate to severe (30- 60) autism severity based on CARS 2 score will be included for the study
Participants who have Sensory Processing issues will be included for the study
Participants who scored above 60 in Brown Executive Function Attention/Scale
Age range of the Participants between 3- 7 years
Parents must know either Tamil or English
|
|
| ExclusionCriteria |
| Details |
Participants with comorbid conditions (e.g. Epilepsy and Neurological conditions)
Children with Photosensitive or light-triggered medical conditions
Presence of metallic or electronic cranial implants
Participants with Open wounds or scalp infections
Participation in other interventional or neuromodulation studies in the past 3 months
Recent head injury or neurosurgery (within 6 months)
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes from baseline in executive function composite scores, sensory processing, symptom severity in asd |
After 9 weeks of intyervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EEG spectral analysis changes |
after 9 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This project investigates the efficacy of integrating transcranial photobiomodulation with occupational therapy versus occupational therapy alone in improving executive function sensory processing and symptom profile in children with ASD through a phase 2 prospective RCT |