| CTRI Number |
CTRI/2025/08/092160 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How Konkani-Kannada readers hear words in their minds while reading |
|
Scientific Title of Study
|
An Investigation on the Phonological Mapping Negativity in Konkani-Kannada Bilingual Readers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashel Melita Fernandes |
| Designation |
Postgraduate student pursuing M.Sc. in Speech- Language Pathology |
| Affiliation |
Manipal College of Health Professions (MCHP) |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8073226501 |
| Fax |
|
| Email |
ashel.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Gopee Krishnan |
| Designation |
Additional Professor |
| Affiliation |
Manipal College of Health Professions (MCHP) |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9036459815 |
| Fax |
|
| Email |
krishnan.g@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ashel Melita Fernandes |
| Designation |
Postgraduate student pursuing M.Sc. in Speech- Language Pathology |
| Affiliation |
Manipal College of Health Professions (MCHP) |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8073226501 |
| Fax |
|
| Email |
ashel.mchpmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions(MCHP), Madhav Nagar,
Manipal – 576104, Udupi District, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Ashel Melita Fernandes |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal- 576104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gopee Krishnan |
Department of Speech and Hearing, MCHP, Manipal |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal- 576104
Udupi
KARNATAKA |
9036459815
krishnan.g@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 - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ICD-10: Z00.0 (Encounter for general examination without complaint, suspected or reported diagnosis) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Group 1 :Fluent in reading both Kannada and Mangalorean Catholic Konkani
Group 2 :Fluent in reading Kannada and No reading proficiency in Mangalorean Catholic Konkani
|
|
| ExclusionCriteria |
| Details |
Individuals with cognitive impairments, reading difficulties, vision loss, or hearing impairments |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Negative peak latency (ms) typically ranging around 250 - 350 ms.
2) Behavioural response which includes reaction time and accurate production of words |
At baseline (during a single testing session) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/08/2025 |
| 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="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
|
Phonological Mapping Negativity (PMN) reflects pre-lexical phonological processing and is sensitive to phonological violations. Research shows that any violations in expected phonological patterns often trigger a negative peak in event related potential (ERP) activity around 250–350 milliseconds. Although Konkani (Mangalorean Catholic Konkani dialect) and Kannada have distinct phonological systems, both languages use the Kannada script in the Udupi district. The primary purpose of this protocol is to investigate PMN in Konkani-Kannada bilingual readers specifically focusing on differences between two groups: Mangalorean Catholic Konkani-Kannada (KK) readers Mangalorean Non-Catholic Konkani-Kannada (NKK) readers
The study hypothesizes that there will be measurable differences in ERP amplitudes around 250–350 ms and behavioral outcomes (reaction time and accuracy) between KK and NKK bilingual readers during nonword reading tasks in Kannada script. The study will involve 40 participants aged 18 to 40. It includes 20 KK readers and 20 NKK readers based on the inclusion and exclusion criteria. After giving informed consent each participant will attend a single session where they will undergo EEG setup using the NeuroScan ERP system. In the session they will complete a brief practice task and participate in a reading task involving around 100 Kannada-script nonwords. Brain responses (PMN), reaction times, and reading accuracy will be recorded. This study aims to fill the gap in understanding phonological processing in bilinguals using a non-alphabetic script reading task, an area that is underexplored compared to monolinguals.
|