| CTRI Number |
CTRI/2024/12/077652 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to evaluate tACS treatment to improve recovery in patients with schizophrenia |
|
Scientific Title of Study
|
Modulating self-referential and interoceptive processing using transcranial alternating current stimulation (tACS): An open-label study to enhance recovery 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 |
Dr. Sreeraj V S |
| Designation |
Associate professor of Psychiatry |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Department of Psychiatry,
NIMHANS, BENGALURU
Bangalore
KARNATAKA
560029
India |
| Phone |
09902597697 |
| Fax |
|
| Email |
vs8sreeraj@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sreeraj V S |
| Designation |
Associate professor of Psychiatry |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Department of Psychiatry,
NIMHANS, BENGALURU
Bangalore
KARNATAKA
560029
India |
| Phone |
09902597697 |
| Fax |
|
| Email |
vs8sreeraj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sreeraj V S |
| Designation |
Associate professor of Psychiatry |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Department of Psychiatry,
NIMHANS, BENGALURU
Bangalore
KARNATAKA
560029
India |
| Phone |
09902597697 |
| Fax |
|
| Email |
vs8sreeraj@yahoo.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road, Bengaluru, Karnataka State, India. PIN-560029 |
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health and Neurosciences |
| Address |
NIMHNAS, Hosur Road, Bengaluru-560029 |
| 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 Sreeraj V S |
National Institute of Mental Health and Neurosciences |
Department of Psychiatry
NIMHANS BENGALURU
Bangalore
KARNATAKA |
09902597697
vs8sreeraj@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS ETHICS COMMITTEE - BEHAVIOURAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy controls for cross-sectional evaluation |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transcranial alternating current stimulation |
A 4x1 montage will be used with 2 mA current being delivered at the central F3 location. The peripheral 4 electrodes will get 25% (0.5mA) current distributed among them. The stimulus will be given based on the individual theta-frequency estimated from the EEG. If for any pragmatic reason, individual theta cannot be estimated, 5Hz will be used for stimulation. All electrodes will be keeping in-phase with no offset current. Five stimulus sessions will be delivered each day at hourly intervals, each session lasting 20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of psychotic disorder as per International Classification of Diseases 10
at least as minimal sociooccupational dysfunction SOFAS more than 20.
On a stable medication for the last 6 weeks with no major functionality in this 6 week period
Providing written informed consent only patients with intact capacity to consent will be approached |
|
| ExclusionCriteria |
| Details |
Features suggestive of risk of harm to self (for example: suicidal risk, catatonia, prolonged nutritional deprivation) or others (for example: aggression or excitement)
Need for Electroconvulsive therapy
Recent history of antibiotic usage within the past 6 weeks
Co-existing inflammatory bowel disease
Co-morbid substance dependence (except caffeine and nicotine)
Any significant medical or neurological disorder or condition affecting auditory, visual or any sensory modalities which remain uncorrected
Any local skin lesion near the site of stimulation or any other contraindication to tACS. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Social and occupational functioning |
6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
heart rate variability markers
electrogastrography markers
Electroencephalography markers
self-referential processing
Psychopathology rating scores |
change from before tACS to 2 days and 6 weeks after tACS |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/12/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
|
The study aims to modulate the intrinsic neural oscillations at a crucial
hierarchical region, left dorsolateral prefrontal cortex (left DLPFC), using
individualised accelerated high-definition theta-tACS and evaluate its impact
on overall recovery as measured by the functioning at the 6th week
of stimulation. We plan to evaluate the functioning as the primary outcome as
the ultimate aim of management in schizophrenia and functional impairment does
not always correlate with any single symptom domain. Moreover, subtle
manifestations such as basic symptoms of self and cognitive deficits, among
others, are not always comprehensively captured by the symptom rating scales
but contributes to dysfunction. We hypothesize that the functional recovery
using theta-tACS would be mediated through changes in interoception (heart rate
variability, electrogastrography), self-referential processing and
psychopathology. |