| CTRI Number |
CTRI/2025/07/091442 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Deep Learning Modeland Brain Data for Early Detection of Neurocognitive Decline |
|
Scientific Title of Study
|
A Novel Approach for the Early Diagnosis of Neurocognitive Disorders (NCDs): Integration of EEG Parameters, Clinical and Radiological Data with Advanced Deep Learning Models |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr. Arunav Garg |
| Designation |
Associate Consultant |
| Affiliation |
Max Super Speciality Hospital (West) |
| Address |
Room No. W6, Institute of Neurosciences, Ground Floor, Max
Super Speciality Hospital (West), (A
Unit of Max Healthcare Institute
Limited), 1, Press Enclave Road,
Saket 1, Press Enclave Road,
Saket South DELHI 110017 India |
| Phone |
9873789160 |
| Fax |
|
| Email |
arunav.garg@maxhealthcare.com |
|
Details of Contact Person Scientific Query
Modification(s)
|
| Name |
Dr. Arunav Garg |
| Designation |
Associate Consultant |
| Affiliation |
Max Super Speciality Hospital (West) |
| Address |
Room No. W6, Institute of Neurosciences, Ground Floor,Max
Super Speciality Hospital (West), (A
Unit of Max Healthcare Institute
Limited), 1, Press Enclave Road,
Saket 1, Press Enclave Road,
Saket South DELHI 110017 India |
| Phone |
9873789160 |
| Fax |
|
| Email |
arunav.garg@maxhealthcare.com |
|
Details of Contact Person Public Query
Modification(s)
|
| Name |
Dr. Arunav Garg |
| Designation |
Associate Consultant |
| Affiliation |
Max Super Speciality Hospital (West) |
| Address |
Room No. W6, Institute of Neurosciences, Ground Floor,Max
Super Speciality Hospital (West), (A
Unit of Max Healthcare Institute
Limited), 1, Press Enclave Road,
Saket 1, Press Enclave Road,
Saket South DELHI 110017 India |
| Phone |
9873789160 |
| Fax |
|
| Email |
arunav.garg@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
INTELLIHEALTH WORLD PVT LTD |
| Address |
1442, Basement, Sector 45
Gurgaon, Haryana – 122001
|
| Type of Sponsor |
Other [Heathcare-Startup] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arunav Garg |
Max Super Speciality Hospital |
Room No. W6, Institute of Neurosciences, Ground Floor,1, Press Enclave Road,
Saket South DELHI |
9873789160
arunav.garg@maxhealthcare.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max Healthcare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G309||Alzheimers disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of mild or major neurocognitive disorder
Cut-off scores for neuropsychological cognitive assessment tests. (MMSE, MoCA, ACE 3, FAB, LBCRS, Hanchinski ischemic score)
|
|
| ExclusionCriteria |
| Details |
1. Conditions mimicking NCD (moderate to severe depression, stroke, Parkinsonism, Epilepsy, endocrine disorders, metabolic disorders, HIV, Brain infections, Vitamin B12 and other nutritional deficiencies, NPH, SDH, paraneoplastic syndrome and autoimmune encephalitis, demyelinating disorders, CJD, Huntington’s disease, Spino-cerebellar ataxia)
2. Significant head injury
3. Current or past history of major psychiatric disorders (e.g severe depression, schizophrenia, bipolar disorder).
4. Substance abuse (including alcohol) or dependence within the past 5 years. Drug intoxication or abuse.
5. Visual/auditory impairments hindering cognitive tasks.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Identify early electrophysiological markers
Classify neurocognitive disorders
Improve early diagnosis
Enable personalized interventions |
Recruitment happens during Year 1 and Year 2.
Follow-up extends through Year 3 and Year 4.
Data analysis and manuscript writing align with Model Evaluation and Reporting phases. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="1036" Sample Size from India="1036"
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)
|
11/08/2025 |
| 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="4" Months="0" Days="0" |
|
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
|
Neurocognitive disorder represents a significant global health challenge, ranking as the seventh leading cause of death worldwide. It is estimated that the number of people with dementia will increase from 57.4 million cases globally in 2019 to 152.8 million cases by 2050. With the global population aging, the early and accurate diagnosis of neurocognitive disorders has become increasingly difficult. This challenge is driven by multiple factors, including the subtle and non-specific nature of early symptoms, limited public awareness of early dementia signs, and the high cost and limited accessibility of current diagnostic methods. As a result, there is a critical need for affordable, non-invasive, and widely accessible diagnostic tools that can facilitate early and accurate identification of neurocognitive disorders. In recent years, deep learning and artificial intelligence (AI) methods have gained attention for their potential in the early diagnosis of neurocognitive disorders. According to a growing body of literature, electroencephalography (EEG)—especially quantitative EEG (qEEG)—can detect brain changes associated with neurocognitive disorders, even in the very early (mild cognitive impairment) stages. In some cases, EEG has been found to be more sensitive than MRI or CT scans. However, current EEG data remains limited and carries its own challenges. Therefore, integrating EEG data with clinical tools and advanced deep learning algorithms holds great promise for improving the accuracy, efficiency, and accessibility of neurocognitive disorder diagnosis. This approach could also prove more cost-effective and scalable, making it suitable for widespread application. The purpose of this study is to develop and evaluate deep learning and AI models for diagnosing minor and major neurocognitive disorders (Alzheimer’s Disease, Vascular Dementia, Frontotemporal Dementia, and Dementia of Lewy body type) using quantitative EEG (qEEG) features, alongside clinical data and known risk factors of NCD. The objective is to leverage the power of deep learning and AI to uncover complex relationships between input variables (EEG and clinical features) and clinical outcomes. This includes identifying latent computational EEG biomarkers within high-dimensional datasets that are not easily discernible by traditional methods. The study aims to support more accurate clinical decision-making, particularly for the early diagnosis of NCD, and to differentiate affected individuals from healthy age-matched controls. Early diagnosis will allow timely treatment, potentially transforming patient outcomes and alleviating the rising burden of neurocognitive disorders on society. |