A randomised control study on evaluating the effects of brain stimulation to the left temporoparietal region on social cognition in patients with schizophrenia having persistent auditory hallucinations
- Conditions
- Health Condition 1: F200- Paranoid schizophrenia
- Registration Number
- CTRI/2023/04/051938
- Lead Sponsor
- ational Institute of Mental Health And Neurosciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Schizophrenia Diagnosis (DSM-5);
2.Age 18-60 years; Kannada, Hindi, Tamil or English speaking
3.Any sex;
4.Right-Handedness [Edinburgh Handedness Inventory (24)];
5.Persistence of auditory hallucinations without remission despite treatment with at least one antipsychotic medication at an adequate dose for a minimum period of six weeks.
6.Non-remission as defined as a score of moderate or high ( >2) on the Global Rating of Hallucinations in the scale for the assessment of positive symptoms.
7.Capacity to consent for research studies as per the assessment using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)(26)
8.Written informed consent.
1.Psychiatric emergency necessitating electroconvulsive therapy;
2.Suicidal risk / any psychiatric emergency;
3.Pregnancy / Post-Partum;
4.Substance use disorder in last six months (except caffeine or nicotine);
5.Co-morbid neurological / medical disease that can affect the brain structure / function;
6.Any Contraindication for Magnetic Resonance Imaging;
7.Any Contraindication for Transcranial Magnetic Stimulation;
8.Any Contraindication for Transcranial Direct Current Stimulation
9.Vision or hearing impairment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome measures: <br/ ><br>a.Change in social cognitive deficit score: <br/ ><br>For self other differentiation- Signal detection theoretical analysis would be used evaluate the sensitivity in decision making using dee prime, criterion and JZS Bayes factor. <br/ ><br>Mean scores of ToM deficit variable (TDV) scores and HCP TOM tasks would be used for TOM and biological motion perception scores respectively <br/ ><br> <br/ ><br> <br/ ><br>Secondary outcome measures: <br/ ><br>Association between change in auditory hallucinations severity with change in social cognitive deficit <br/ ><br> <br/ ><br>score: <br/ ><br>Response to brain stimulation would be quantified as change in AHRS scores in two ways: <br/ ><br>â?¢As a continuous outcome- Pre-treatment score- Post-treatment score/ Pre-treatment score <br/ ><br>â?¢As a categorical outcome- Participants with 30% change in AHRS scores <br/ ><br>Timepoint: Time point 1: Baseline <br/ ><br>Time point 2: After 15 days of intervention
- Secondary Outcome Measures
Name Time Method Association between change in auditory hallucinations severity with change in social cognitive deficit <br/ ><br> <br/ ><br>score: <br/ ><br>Response to brain stimulation would be quantified as change in AHRS scores in two ways: <br/ ><br>â?¢As a continuous outcome- Pre-treatment score- Post-treatment score/ Pre-treatment score <br/ ><br>â?¢As a categorical outcome- Participants with 30% change in AHRS scores <br/ ><br>Timepoint: Time point 1: Baseline <br/ ><br>Time point 2: After 15 days of intervention