| CTRI Number |
CTRI/2025/11/097930 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
23/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the Neural Process of Memory and the Ability to Discriminate Between Self and Non-self Aspects in Schizophrenia |
|
Scientific Title of Study
|
Neurobiological Correlates of Self-Other Discrimination and Declarative Memory in
Schizophrenia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Vyoma Shah |
| Designation |
PhD Scholar |
| Affiliation |
National institute of Mental Health and Neuro Sciences (NIMHANS) |
| Address |
Department of Psychiatry, National Institute of Mental Health and Neuro Sciences NIMHANS, Hosur Road
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995930 |
| Fax |
|
| Email |
vyomashah97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Venkatasubramanian |
| Designation |
Professor |
| Affiliation |
National institute of Mental Health and Neuro Sciences (NIMHANS) |
| Address |
Department of Psychiatry, National Institute of Mental Health and Neuro Sciences NIMHANS, Hosur Road
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995256 |
| Fax |
|
| Email |
venkat.nimhans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Venkatasubramanian |
| Designation |
Professor |
| Affiliation |
National institute of Mental Health and Neuro Sciences (NIMHANS) |
| Address |
Department of Psychiatry, National Institute of Mental Health and Neuro Sciences NIMHANS, Hosur Road
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995256 |
| Fax |
|
| Email |
venkat.nimhans@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neuro Sciences, Hosur Road, Lakkasandra, Wilson Garden, Bengaluru - 560029, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health and Neuro Sciences NIMHANS |
| Address |
National Institute of Mental Health and Neuro Sciences, Hosur Road, Lakkasandra, Wilson Garden, Bengaluru - 560029, Karnataka, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 G Venkatasubramanian |
Department of Psychiatry, National Institute of Mental Health and Neuro Sciences |
Hosur Rd, near Bangalore Milk Dairy, Hombegowda Nagar, Bengaluru, Karnataka 560029
Bangalore
KARNATAKA |
080 26995256
venkat.nimhans@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee (Behavioural Sciences Division) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers will be used for comparison |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Healthy control |
Nil |
| Intervention |
Transcranial Alternating Current Stimulation (tACS) |
Theta tACS(6 Hz) will be administered at AFz using a central electrode with surrounding four return electrodes at 1 mA.
The theta tACS will be true or sham and will be adjusted for the tolerability of the participant. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
FOR PATIENTS WITH SCHIZOPHRENIA:
Diagnosis of Schizophrenia as per the International Classification of Diseases, 11th Revision
Age 18 to 45 years
Any sex
Capacity to consent for research studies as per the assessment using the University of California, San Diego Brief Assessment of Capacity to Consent
Written Informed consent
Education level should be at least 10th standard
Scale for the Assessment of Positive Symptoms Global Delusional and or Hallucinations scores between 2 to 4
FOR HEALTHY VOLUNTEERS:
Age Range: 18-45 years
Any sex
Written Informed Consent
Education level should be at least 10th standard
Please note all the diagnoses made will be according to the International Classification of Diseases, 11th Revision and NOT the International Classification of Diseases, 10th Revision. |
|
| ExclusionCriteria |
| Details |
FOR PATIENTS WITH SCHIZOPHRENIA:
Psychiatric emergency necessitating electroconvulsive therapy
Suicidal risk or any psychiatric emergency
Pregnancy or Post-Partum
Substance use disorder in last six months except caffeine or nicotine
Hindi Mental status examination score less than 24
Co-morbid neurological or medical disease that can affect the brain structure or function
Clinically significant ophthalmological conditions
Any Contraindication for Magnetic Resonance Imaging
Any Contraindication for tACS
FOR HEALTHY VOLUNTEERS:
Diagnosis of a psychiatric disorder
Pregnancy or Post-Partum
Current psychoactive substance dependence, except caffeine and nicotine
Co-morbid neurological/medical diseases that can affect the brain structure/function
Hindi mental status examination score less than 24
Clinically significant ophthalmological conditions
Any contraindication for Magnetic Resonance Imaging
Any contraindication for tACS
Please note all the diagnoses made will be according to the International Classification of Diseases, 11th Revision and NOT the International Classification of Diseases, 10th Revision. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
tACS induced differential changes in the recognition
score and evoked electrophysiological responses in the self-referential memory task between patients with schizophrenia and healthy controls |
Baseline & After tACS (True or Sham) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
10/12/2025 |
| 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="2"
Months="4"
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
|
Background:
Self-referential memory, a subtype of declarative memory that involves the encoding and retrieval of self-related information, has been closely associated with theta-band oscillations (4–8 Hz). These oscillations facilitate communication between the hippocampus and the prefrontal cortex, regions critically involved in memory processing. Empirical evidence suggests that enhanced theta synchronisation is linked to improved memory performance. Transcranial alternating current stimulation (tACS) at theta frequency has been shown to modulate these endogenous oscillations, providing a non-invasive means to probe their causal role in memory function.
In schizophrenia, self-referential memory is often attenuated; however, the underlying oscillatory mechanisms contributing to this deficit remain poorly understood. Modulating theta activity through tACS may therefore offer valuable insights into the neural dynamics of both typical and impaired self-referential processing. Need for the study:
Therefore, investigating the effects of theta-frequency tACS on self-referential memory can enhance our understanding of the oscillatory dynamics supporting self-related cognition. This study may further inform the development of targeted neuromodulatory interventions aimed at ameliorating cognitive and self-processing deficits in schizophrenia. |