| CTRI Number |
CTRI/2023/03/050442 [Registered on: 07/03/2023] Trial Registered Prospectively |
| Last Modified On: |
06/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of brain stimulation on self related information processing in schizophrenia patients
hearing medication incurable voices: A study of brain cognition, physiology and imaging related to the disease |
|
Scientific Title of Study
|
“Effect of Neuromodulation on Ipseity Encoding in Schizophrenia Patients with
Persistent Auditory Hallucinations: Neurocognitive, Neurophysiological & Neuroimaging
Studies†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Muralidharan |
| Designation |
Professor of Psychiatry |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Medical Superintendent office
National Institute of Mental Health and Neurosciences
Bengaluru, Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
|
| Fax |
|
| Email |
drmuralidk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishant Goyal |
| Designation |
Professor of Psychiatry |
| Affiliation |
Central Institute of Psychiatry, Ranchi |
| Address |
Department office
K S Mani Centre for cognitive Neurosciences
Patratoli, Kanke, Jharkhand
Ranchi
JHARKHAND
834006
India |
| Phone |
9431171162 |
| Fax |
|
| Email |
psynishant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subham Samantaray |
| Designation |
Non-PG SeniorResident |
| Affiliation |
Central Institute of Psychiatry, Ranchi |
| Address |
Department office
K S Mani Centre for cognitive Neurosciences
Patratoli, Kanke, Jharkhand
Ranchi
JHARKHAND
834006
India |
| Phone |
8895615688 |
| Fax |
|
| Email |
samantasubham@gmail.com |
|
|
Source of Monetary or Material Support
|
| DBT/Wellcome Trust India Alliance (India Alliance)
ishant House, 8-2-351/N/1, 2nd floor, Road No. 2, Venkateshwara Hills, Banjara Hills, Hyderabad - 500034 |
|
|
Primary Sponsor
|
| Name |
DBT/Wellcome Trust India Alliance (India Alliance) |
| Address |
Nishant House, 8-2-351/N/1, 2nd floor, Road No. 2, Venkateshwara Hills, Banjara Hills, Hyderabad - 500034 |
| Type of Sponsor |
Government funding agency |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nishant Goyal |
K. S Mani Centre for Cognitive NeurosciencesCentral Institute of Psychiatry |
K. S Mani Centre for Cognitive Neurosciences
Central Institute of Psychiatry
Patratoli,
Kanke,
Jharkhand 834006
Ranchi
JHARKHAND |
9431171162
psynishant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, NIMHANS, BENGALURU and INSTITUTE ETHICS COMMITTEE, CENTRAL INSTITUTE OF PSYCHIATRY, RANCHI |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Healthy controls: No intervention will be provided. Only event related potentials will be acquired |
Healthy controls: No intervention will be provided. Only event related potentials will be acquired |
| Intervention |
Transcranial Magnetic Stimulation and transcranial direct current stimulation |
TMS INTERVENTION:
1. Continuous theta burst stimulation TMS OVER left TPJ at 120 percent of RMT. 600 pulses every 5 minute. Three cycles, making a total of 1800 pulses.
2. 2 sessions will be deliver 3 hours apart.
3. Corresponding sham stimulation for tDCS
t-DCS INTERVENTION:1. Conventional tDCS; cathode over left TPJ and anode over left DLPFC. 2mA of current with 20 seconds fade in fade out phase- will be delivered for 20 minutes.
2. 2 sessions will be delivered 3 hours apart.
3. Corresponding sham TMS will be delivered |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Schizophrenia Diagnosis according to the DSM-5 2. Age 18-45 years;
3. Any sex;
4. Right-Handedness using Edinburgh Handedness Inventory
5. Persistence of auditory hallucinations without remission despite treatment with at least one antipsychotic medication at an adequate dose for a minimum duration of six weeks. (Non-remission is defined as a score of moderate or high (>2) on the Global Rating of Hallucinations in the scale for the assessment of positive symptoms (SAPS)
6. Capacity to consent for research studies as per the assessment using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)
7. Ability to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Psychiatric emergency necessitating electroconvulsive therapy;
2. Suicidal risk / any psychiatric emergency;
3. Score of > 6 on Calgary Depression Rating Scale (Addington et al.,1994);
4. Pregnancy / Post-Partum;
5. substance use disorder in last six months (except caffeine ornicotine);
6. Co-morbid neurological / medical disease that can affect the brain structure / function.
7. Any Contraindication for Magnetic Resonance Imaging;
8. Any Contraindication for Transcranial Magnetic Stimulation.
9. Any Contraindication for Transcranial Direct Current Stimulation. 10. Hearing impairment
11. History of significant head injury (loss of consciousness more than30 minutes or any permanent sequelae) |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the neuromodulatory effect of cTBS and tDCS (Neuromodulation) on ipseity encoding(measured by DIFFERENCE OF N100 amplitude between talk and listen condition) and source monitoring deficit(P300 amplitude measured during source monitoring task) in patients with persistent auditory hallucination with schizophrenia via specific event related potential(ERP) parameters |
The effect will be determined by assessing the ERP parameters at 2 time points: before neuromodulation treatment and after 15 days of neuromodulation treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the ipseity monitoring ERPs in schizophrenia patients with medicationresistant persistent auditory hallucination with that of matched healthy control.
2. To compare the relative improvement of ipseity monitoring ERPs in schizophrenia patients with medication-resistant persistent auditory hallucination after cTBS TMS and tDCS intervention.
3.To evaluate the resting-state fMRI correlates of ipseity monitoring deficit and its change with NIBS intervention in patients of schizophrenia with medication-resistant persistent auditory hallucination.
4. To correlate the change in neurophysiological(ERPs) and neuroimaging (resting state fMRI) data evaluating ipseity monitoring deficit and itsimprovement with NIBS intervention with that of psychopathological variables assessing the severity of auditory hallucination in patients of schizophrenia with medication resistant persistent auditory hallucination.related potential studies. |
2 time points: before intervention and after intervention |
|
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Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
15/03/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
1. The trial is a part of PhD work jointly conducted at the Central Institute of Psychiatry (CIP), Ranchi and NIMHANS, Bengaluru. 2. The PhD has been registered at NIMHANS. The data collection would happen at CIP and training and guidance will be provided by the mentors from both NIMHANS and CIP. 3. The funding for the work has been provided by DBT-Wellcome trust, India Alliance. 4. The patients recruited under the trial "Clinical Research Centre for Neuromodulation in Psychiatry" study2 (CTRI registration number - CTRI/2021/05/033783) will be exposed to additional ERP experiments to collect the requisite data. 5. No separate intervention would be provided to the study sample. |