| 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
|
|
|
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
|
|
|
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. |