| CTRI Number |
CTRI/2024/09/074257 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Eye gaze screening tool for autism detection |
|
Scientific Title of Study
|
Validation of an eye gaze screening protocol for early identification of autism |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Tiwari |
| Designation |
Associate Professor |
| Affiliation |
MCHP ,MAHE Manipal |
| Address |
Department of Speech and Hearing , Manipal College of Health Professions, Manipal University,Manipal-576104, Karnataka,India
Udupi KARNATAKA 576104 India |
| Phone |
9986448718 |
| Fax |
|
| Email |
shivani.tiwari@manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Shivani Tiwari |
| Designation |
Associate Professor |
| Affiliation |
MCHP ,MAHE Manipal |
| Address |
Department of Speech and Hearing , Manipal College of Health Professions, Manipal University,Manipal-576104, Karnataka,India
KARNATAKA 576104 India |
| Phone |
9986448718 |
| Fax |
|
| Email |
shivani.tiwari@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Shivani Tiwari |
| Designation |
Associate Professor |
| Affiliation |
MCHP ,MAHE Manipal |
| Address |
Department of Speech and Hearing , Manipal College of Health Professions, Manipal University,Manipal-576104, Karnataka,India
KARNATAKA 576104 India |
| Phone |
9986448718 |
| Fax |
|
| Email |
shivani.tiwari@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O.Box No.4911 Ansari Nagar,New Delhi-110029,India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Self |
Dept. of Speech and Hearing, MCHP, MAHE, Manipal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivani Tiwari |
Kasturba Hospital Manipal |
Madhavnagar, Manipal Udupi KARNATAKA |
09986448718
shivani.tiwari@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
9.00 Month(s) |
| Age To |
30.00 Month(s) |
| Gender |
Both |
| Details |
1. Infants between 9 – 30 months of age
2. Siblings of children with ASD
3. Infants with high-risk factors
4. Normal vision and hearing |
|
| ExclusionCriteria |
| Details |
1. Uncorrected vision
2. Any other associated problems
3. Delayed motor milestones |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The validity of the eye gaze-based screening protocol will be measured by obtaining the proportion of
children who develop and do not develop ASD at the follow-up visit out of infants who were screened
(including those who passed and failed) to derive the sensitivity and specificity values. |
week 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/10/2024 |
| 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="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Early identification of ASD is, at present, a global challenge. Several factors like increased behavioral variability at a young age, heterogenic profiles of the ASD as well as the overlapping features of this condition with other developmental disorders complicate the early detection of children with ASD. While several biomarkers of ASD have been identified and proposed in the recent years, many of these face criticism because of time constraints, cost factors, and lack of replicability. Of late, the eye-tracking technology has provided the opportunity to detect even subtle aberrations in eye gaze during social interaction in young children with ASD. Being a non-invasive technique, the eye-tracking and gaze monitoring in young children are advantageous over several other methods like neuroimaging and biochemical investigations. In the recent years, several researchers have proposed eye-tracking paradigms and tasks to assess gaze monitoring in children with ASD using a range of stimuli. However, most of such evidence is drawn from only observational studies that compare children with ASD and typically-developing (TD) controls. That is, these tasks and paradigms are not validated across various settings and age ranges, thereby limiting their application in screening and early identification of children with ASD. Hence, it is necessary to examine various eye-tracking paradigms and tasks proposed for children with ASD to identify the valid paradigms and tasks for the early identification of ASD.
The proposed project is expected to validate an eye gaze based screening protocol for early detection of children with ASD that may provide an easy and quick screening test that can be used by health providers like pediatricians. This would help in early identification, monitoring, and intervention of children with ASD, thereby improving the outcome and quality of life of families and children with ASD. This study would be the first of its kind in the Indian context and would be relevant given the country population and rising incidence of ASD. |