Health Condition 1: F200- Paranoid schizophrenia
Conditions
Interventions
Intervention1: Transcranial Magnetic stimulation- continuous theta burst with sham transcranial direct current stimulation: MRI guided continuous theta burst stimulation will be delivered to the Left
600 pulses.
Sponsors
National Institute of Mental Health And Neurosciences
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures: a.Change in social cognitive deficit score: 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. Mean scores of ToM deficit variable (TDV) scores and HCP TOM tasks would be used for TOM and biological motion perception scores respectively Secondary outcome measures: Association between change in auditory hallucinations severity with change in social cognitive deficit score: Response to brain stimulation would be quantified as change in AHRS scores in two ways: â?¢As a continuous outcome- Pre-treatment score- Post-treatment score/ Pre-treatment score â?¢As a categorical outcome- Participants with 30% change in AHRS scores Timepoint: Time point 1: Baseline Time point 2: After 15 days of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Association between change in auditory hallucinations severity with change in social cognitive deficit score: Response to brain stimulation would be quantified as change in AHRS scores in two ways: â?¢As a continuous outcome- Pre-treatment score- Post-treatment score/ Pre-treatment score â?¢As a categorical outcome- Participants with 30% change in AHRS scores Timepoint: Time point 1: Baseline Time point 2: After 15 days of intervention | — |
Countries
India
Contacts
Public ContactChithra Uppinkudru
National Institute of Mental Health and Neurosciences
Outcome results
None listed