| CTRI Number |
CTRI/2025/10/096632 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of magnetic stimulation by accelerated iTBS in negative symptoms of schizophrenia |
|
Scientific Title of Study
|
Efficacy of accelerated intermittent theta burst stimulation (iTBS) on negative symptoms among individuals with Schizophrenia: A randomised sham controlled study |
| 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 Vaishnavi Raj |
| Designation |
Junior Resident, Psychiatry |
| Affiliation |
Institute of medical sciences, BHU |
| Address |
Plot no 105, Ramjaipal Nagar, Gola Road, Danapur Cantt, Patna
Department of Psychiatry, Institute of medical sciences, BHU
Patna
BIHAR
801503
India |
| Phone |
07518816580 |
| Fax |
|
| Email |
rajv1919@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Gupta |
| Designation |
Assistant Professor, Psychiatry |
| Affiliation |
Institute of medical sciences, BHU |
| Address |
Sir Sunderlal Hospital, Trauma Center Complex, Department of Psychiatry, BHU, Varanasi, Uttar Pradesh, 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9990556662 |
| Fax |
|
| Email |
pankajg0891@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishnavi Raj |
| Designation |
Junior Resident, Psychiatry |
| Affiliation |
Institute of medical sciences, BHU |
| Address |
Plot no 105, Ramjaipal Nagar, Gola Road, Danapur Cantt, Patna
Department of Psychiatry, Institute of medical sciences, BHU
BIHAR
801503
India |
| Phone |
07518816580 |
| Fax |
|
| Email |
rajv1919@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Hospital, Trauma Center Complex, Department of Psychiatry, BHU, Varanasi, Uttar Pradesh, 221005 |
|
|
Primary Sponsor
|
| Name |
Sir Sunderlal Hospital |
| Address |
Trauma center Complex, Department of psychiatry, BHU, Varanasi, Uttar Pradesh, 221005 |
| 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 Vaishnavi Raj |
Sir Sunderlal Hospital |
Trauma center complex, Department of Psychiatry, 4th floor, rTMS room
Varanasi
UTTAR PRADESH |
7518816580
rajv1919@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Accelerated iTBS |
Accelerated iTBS will be performed using NEURO-MS.NET - magnetic stimulator software (version 3.2.10.1). The left DLPFC region of the brain will be targeted using neural navigation by software- neural navigator. The coil will produce 3 pulses of 50 Hz burst, given for 1.8 seconds with 8 seconds of inter-train interval. Therefore, a total of 5 Hz train frequency will be given for treatment. A 3 minutes protocol which will deliver 600 pulses in one session will be delivered. Similar session will be provided thrice a day for 5 days/week for 2 weeks, thus delivering a total of 1800 pulses per day for 10 days. |
| Comparator Agent |
Sham iTBS |
Sham iTBS using sham coil of rTMS of same duration as of active intervention in similar settings. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosis of schizophrenia using diagnostic criteria of international classification of disease- 11th edition (ICD-11)
2.Male or female of age between 18 years to 60 years
3.Schizophrenia patients who haven’t received rTMS or ECT in the past 6 months
4.The Positive and negative syndrome scale for schizophrenia- negative symptoms score of more than 15
5.Scale for assessment of negative symptoms score more than 20
6.Willingness to give informed consent
|
|
| ExclusionCriteria |
| Details |
1.Presence of comorbid neurological, medical or other psychiatric disorder that are interfering with the study or patient being unmanageable due to acute illness or severity of the existing disorder
2.Patients with comorbid substance dependence, except nicotine and caffeine
3.Having any metallic implants/parts in body
4.Patients having a history of head trauma with loss of consciousness
5.Patients with a history of seizure/convulsion or having epilepsy or family history of same.
6.Patients with raised intracranial tension
7.Patients with a history of neurosurgery of any type ( brain or spinal cord) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the efficacy of accelerated intermittent theta burst stimulation in negative symptoms of patients with schizophrenia
2.To compare the efficacy of accelerated intermittent theta burst stimulation in negative symptoms of schizophrenia patients with that of the control group |
Baseline and 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of accelerated intermittent theta burst stimulation in positive symptoms of patients with schizophrenia
To compare the efficacy of accelerated intermittent theta burst stimulation in positive symptoms of schizophrenia patients with that of the control group |
Baseline and 2 weeks |
To assess the efficacy of accelerated intermittent theta burst stimulation in cognitive functions of patients with schizophrenia
To compare the efficacy of accelerated intermittent theta burst stimulation in cognitive functions of schizophrenia patients with that of the control group |
Baseline and 2 weeks |
| To assess the safety and tolerance of accelerated iTBS in patients with schizophrenia |
Baseline, 1 week and 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
15/11/2025 |
| 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="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
|
Study design - Randomized controlled trial, with study topic of EFFICACY OF ACCELERATED INTERMITTENT THETA BURST STIMULATION (iTBS) ON NEGATIVE SYMPTOMS AMONG INDIVIDUALS WITH SCHIZOPHRENIA: A RANDOMISED SHAM CONTROLLED STUDY, being carried out in department of Psychiatry, IMS BHU Varanasi with sample size of 82 cases including accelerated iTBS protocol for 2 weeks with pre and post interventional assessments. |