| CTRI Number |
CTRI/2018/02/012061 [Registered on: 21/02/2018] Trial Registered Prospectively |
| Last Modified On: |
22/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of non invasive brain stimulation using direct current treatment on auditory hallucinations in schizophrenia |
|
Scientific Title of Study
|
Neuroimaging Correlates and Immediate Effects of High-Definition tDCS on persistent Auditory Verbal Hallucinations in Schizophrenia
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rujuta U Parlikar |
| Designation |
PhD scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Psychiatry, National Institute of Mental Health and Neurosciences
Bangalore,560029
Karnataka,
India
Bangalore
KARNATAKA
560029
India |
| Phone |
080-26995366 |
| Fax |
|
| Email |
rujuta@parlikar.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Venkatasubramanian |
| Designation |
Professor of Psychiatry |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Psychiatry, National Institute of Mental Health and Neurosciences
Bangalore,560029
Karnataka,
India
Bangalore
KARNATAKA
560029
India |
| Phone |
080-26995256 |
| Fax |
|
| Email |
venkat.nimhans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rujuta U Parlikar |
| Designation |
PhD scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Psychiatry, National Institute of Mental Health and Neurosciences
Bangalore,560029
Karnataka,
India
Bangalore
KARNATAKA
560029
India |
| Phone |
080-26995366 |
| Fax |
|
| Email |
rujuta@parlikar.com |
|
|
Source of Monetary or Material Support
|
| This is a PhD Thesis done in the Department of Psychiatry at the National Institute of Mental Health And Neurosciences, Bengaluru, INDIA
|
|
|
Primary Sponsor
|
| Name |
National Institute of Mental health and Neurosciences |
| Address |
Department of Psychiatry, National Institute of Mental Health and Neurosciences
Bangalore,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 Rujuta Parlikar |
National Institute of Mental Health And Neurosciences (NIMHANS) |
006, Translational Psychiatry Lab,
Neurobiology Research Center,
Department of Psychiatry,
NIMHANS
Bangalore
Bangalore
KARNATAKA |
08425881284
rujuta@parlikar.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS, Institute Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sham - High Definition trans-cranial Direct Current Stimulation(HD-tDCS) |
Sham - High Definition trans-cranial Direct Current Stimulation(HD-tDCS) |
| Intervention |
True High Definition trans-cranial Direct Current Stimulation (HD-tDCS) |
It is a non invasive neuromodulatory brain stimulation technique that delivers low intensity direct current, using scalp based electrodes facilitating or inhibiting spontaneous neuronal activity. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Diagnosis of schizophrenia / schizophreniform disorder as per DSM criteria (Diagnostic and Statistical Manual for Mental Disorders, American Psychiatric Association); 2) Persistent auditory hallucination despite adequate antipsychotic medication (atleast one antipsychotic trial) with unchanged dose at least for the past 4 weeks. 3) Clinically Significant Auditory Verbal Hallucinations as defined by a structured rating scale for assessing auditory hallucination; 4) Age range: 18 – 45 years; 5) Both sexes; 6) Right Handedness and 7) Having satisfactory capacity to consent. 8) Written informed consent. |
|
| ExclusionCriteria |
| Details |
1) Features suggestive of psychiatric emergency (for example: suicidal risk, aggression, excitement, catatonia, prolonged nutritional deprivation or any other status requiring intensive clinical care), 2) Any contraindication to HD-tDCS procedure – (i) metal in the head, (ii) implanted brain medical devices, (iii) local lesion or injury in the scalp / head, 3) Any concurrent co-morbid psychiatric diagnosis; 4) Pregnancy or post-partum status; 5) Any contraindication for MRI; and 6) Left Handedness.
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|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Severity of auditory hallucinations.
2. Change in the neural correlates involved in auditory hallucinations(Using brain imaging techniques like structural MRI, resting fMRI and DTI)
|
Twice. First day (Day 0), before the treatment with HD-tDCS is given. And second on the last day(day 5), after the second session of HD-tDCS treatment is over. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity of positive and negative symptoms |
Twice. First day (Day 0), before the treatment with HD-tDCS is given. And second on the last day(day 5), after the second session of HD-tDCS treatment is over. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2018 |
| Date of Study Completion (India) |
28/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
No publications yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized double blinded, placebo controlled trial which will explore auditory hallucination; one of the most fundamental symptoms of schizophrenia, occurring in majority of the total schizophrenia patients of which about 20 - 30% might be unresponsive to medications. This study seeks to understand the neural correlates of persistent auditory verbal hallucinations in schizophrenia patients in comparison with healthy controls and also the changes in neural activity, before and after brain stimulation using add-on HD-tDCS technique (wherein low intensity weak direct currents act on cortical areas, thus facilitating or inhibiting spontaneous neuronal activity). This study will also be able to comment on the usefulness and efficacy of add-on HD-tDCS as a treatment modality for patients suffering from persistent auditory verbal hallucinations in schizophrenia. |