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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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