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CTRI Number  CTRI/2025/04/085745 [Registered on: 28/04/2025] Trial Registered Prospectively
Last Modified On: 25/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Examine the applicability of games for cognitive assessment 
Scientific Title of Study   Virtual Reality Games for Cognitive Assessment (VR-GCA) in MCI Subjects: A cross-sectional observational study.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ECR/238/Inst/KA/2013/RR-24  DCGI 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Veeky Baths 
Designation  Professor 
Affiliation  Cognitive Neuroscience Lab, Department of Biological Sciences 
Address  C-213, Department of Biological Sciences, C-302, Birla Institute of Technology and Sciences Pilani K. K. Birla Goa Campus, NH 17B, Bypass, Road, Zuarinagar, Sancoale, Goa 403726

South Goa
GOA
403726
India 
Phone  9823764987  
Fax    
Email  veeky@goa.bits-pilani.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Veeky Baths 
Designation  Professor 
Affiliation  Cognitive Neuroscience Lab, Department of Biological Sciences 
Address  Department of Biological Sciences, C-302, Birla Institute of Technology and Sciences Pilani K. K. Birla Goa Campus, NH 17B, Bypass, Road, Zuarinagar, Sancoale, Goa 403726

South Goa
GOA
403726
India 
Phone  9823764987  
Fax    
Email  veeky@goa.bits-pilani.ac.in  
 
Details of Contact Person
Public Query
 
Name  Veeky Baths 
Designation  Professor 
Affiliation  Cognitive Neuroscience Lab, Department of Biological Sciences 
Address  C-213, Department of Biological Sciences, C-302, Birla Institute of Technology and Sciences Pilani K. K. Birla Goa Campus, NH 17B, Bypass, Road, Zuarinagar, Sancoale, Goa 403726


GOA
403726
India 
Phone  9823764987  
Fax    
Email  veeky@goa.bits-pilani.ac.in  
 
Source of Monetary or Material Support  
Evoreality Private Limited, C/o Paresh Navnitlal Mehta, 2nd Floor, Vimco Towers, Amravati - 444601 Maharashtra India 
 
Primary Sponsor  
Name  EvoReality Pvt. Limited 
Address  2nd Floor, Vimco Towers, Amravati – 444601 Maharashtra 
Type of Sponsor  Other [Private Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ananya Rakesh Sharma  St. Johns Medical College Hospital  Room 42/66, Ground floor, Unit of Neurology/Neurosurgery Physiotherapy,Department of Physiotherapy, St. John’s Medical College Hospital, Sarjapur Road, Bangalore - 560034 , Karnataka, India.
Bangalore
KARNATAKA 
6363542916

ananya.sharma@stjohns.in  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee , St Johns Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G318||Other specified degenerative diseases of nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age 60 years and above.
2. Diagnosed with MCI.
3. Able to understand written and verbal English/Hindi/Kannada/Tamil.
4. Willing to complete the questionnaires that form the part of the study.
 
 
ExclusionCriteria 
Details  1. Disability that hinders participation in the study.
2. Medically unstable
3. Motor or non-motor neurological deficits that hinder participation in the study.
4. Diagnosed with a contagious condition
5. History of epilepsy.
6. History of vertigo or diagnosed with vestibular disorders.
7. Prone to motion sickness.
8. Other severe psychiatric disturbances.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. ACE, Trail Making, DSST, Verbal Learning, Visuospatial, IADL-E, Lifestyle questionnaire, IQ CODE
2. VR Games scores
3. Tablet game scores
4. Game feedback
 
All outcomes are measured at baseline.  
 
Secondary Outcome  
Outcome  TimePoints 
Perception & experience of MCI patients on game-based assessments.   Baseline 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   14/05/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

  Introduction

Proposed research aims to test novel tools of cognitive assessment based on Virtual Reality and Tablet/Laptop on people with mild cognitive impairment (MCI). Given the limitations of the traditional neuropsychological assessment tools in estimating the real-world abilities, and lack of power for capturing early-stage cognitive deterioration, novel tools based on VR/Tablet can provide deeper insights. Research on these tools is at a preliminary stage globally and no large-scale studies in India currently exist. Given the wide population of India and the lack of adequate neurologists, there is a need for technology-based tools for efficient decision making into the cognitive health of the people, especially elderly group.

  Justification / need for the study

There are currently no large-scale studies in India on the clinical population (MCI) using VR games for cognitive assessment. The study provides an opportunity to experiment on novel and emerging tools like VR for cognitive assessment. Given the limitations of the traditional neuropsychological tests (Chaytor & Schmitter-Edgecombe, 2003; Sbordone & Long, 1996; Spooner & Pachana, 2006), VR based games for cognitive assessment provide greater opportunities to assess cognitive abilities in real-world type environments.

 

Furthermore, due to the 3D immersive nature of the Virtual Reality (VR), the games can mimic the real-world cognitive load, thereby provide more realistic assessment of functional cognitive abilities of the participants. Potentially, this ability to provide ecologically valid assessment can lead to early detection of non-symptomatic cognitive decline.


Project Aim 

The aim of this project is to pilot, and evaluate the Virtual Reality based goal-oriented games in the MCI people and to obtain feedback from the primary stakeholders in the clinical settings, such as caregivers, physicians, nurses, neurologist and allied specialists. Through the results of these, we also aim to arrive at a definitive understanding of the efficacy of the VR-based cognitive assessment and rehabilitation in the Indian scenario.

-       Objectives

1.     Pilot the 2 VR-based Games and 2 Tablet based games in MCI patients and compare their scores against the ACE-III and MoCA Scores of the patients.

2.     Based on the results of Objective (1) analyse the findings in context of simultaneous ACE-III administration among the MCI patients.

3. Conduct qualitative interviews with the caregivers, medical personnel and patients about the use of VR games for cognitive assessment and document the feedback of each stakeholder in detail. 
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