Health Condition 1: F20- Schizophrenia
Conditions
Interventions
Intervention1: Continuous Theta Burst Stimulation with sham transcranial direct current stimulation: Continuous Theta Burst Stimulation will be delivered to the left temporoparietal junction (TPJ) as
in a continuous train of 40 seconds, repeated thrice at intervals of 5 minutes for a total of 1800 pulses per session
at 120%RMT. Two such sessions will be delivered each day, spaced across at least 3 hours.
Sham tDCS (cathode: left-TPJ
anode: left-prefrontal
twice-daily, 20-minute sessions will be administered using 5x7 electrodes with 3 hours of intersession interval with stimulation using sham parameters
Intervention2: Cathodal transcranial direct curre
twice-daily, 20-minutes sessions will be administered using 5x7 electrodes at 2mA with 3 hours of intersesion interval. For sham TBS - intermediate theta-burst stimulation paradigm (im-TBS) ââ?¬â??
600 pulses.
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Department of Psychiatry National Institute of Mental Health and Neuro Sciences
Central Institute of Psychiatry
Kasturba Medical College
Eligibility
Inclusion criteria
Inclusion criteria: 1.Schizophrenia Diagnosis (DSM-5); 2.Right-Handedness [Edinburgh Handedness Inventory); 3.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. 4.Non-remission defined as a score of moderate or high ( >2) on the Global Rating of Hallucinations in the scale for the assessment of positive symptoms. 5.Capacity to consent for research studies as per the assessment using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) 6.Written informed consent.
Exclusion criteria
Exclusion criteria: 1.Psychiatric emergency necessitating electroconvulsive therapy; 2.Suicidal risk / any psychiatric emergency; 3.Score of > 6 on Calgary Depression Rating Scale 4.Pregnancy / Post-Partum; 5.Substance use disorder in last six months (except caffeine or nicotine); 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resting state functional brain connectivityTimepoint: Time Point-1 (T1): Baseline-1 (i.e before part-1 intervention) Time Point-2 (T2): After 15 days of part-1 intervention [true cTBS with sham tDCS (OR) true c-tDCS with sham cTBS] Time Point-3 (T3): Baseline-2 (i.e. before part-2 intervention) Time Point-4 (T4): After 15 days of part-2 intervention [true cTBS with sham tDCS (OR) true c-tDCS with sham cTBS] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Auditory Hallucination Rating Scale (AHRS) 2.Scale for the Assessment of Positive Symptoms (SAPS) 3.Scale for the Assessment of Negative Symptoms (SANS) 4.Calgary Depression Scale for Schizophrenia (CDSS) 5.Clinical Global Impressions (CGI) Scale 6.Structured assessment of DisabilityTimepoint: Time Point-1 (T1): Baseline-1 (i.e before part-1 intervention) Time Point-2 (T2): After 15 days of part-1 intervention [true cTBS with sham tDCS (OR) true c-tDCS with sham cTBS] Time Point-3 (T3): Baseline-2 (i.e. before part-2 intervention) Time Point-4 (T4): After 15 days of part-2 intervention [true cTBS with sham tDCS (OR) true c-tDCS with sham cTBS];1.Cognitive function as assessed using Brief Assessment of Cognition in Schizophrenia (BACS) 2. Brain magnetic imaging measures (diffusion tensor images, glutamate levels at left dorsolateral prefrontal cortex from MR spectroscopy) 3. Electroencephalography measures 4. TMS-tDCS perturbation study metrics 5. Heart Rate Variability measuresTimepoint: Time Point-1 (T1): Baseline-1 (i.e before part-1 intervention) Time Point-2 (T2): After 15 days of part-1 intervention [true cTBS with sham tDCS (OR) true c-tDCS with sham cTBS] Time Point-3 (T3): Baseline-2 (i.e. before part-2 intervention) Time Point-4 (T4): After 15 days of part-2 intervention [true cTBS with sham tDCS (OR) true c-tDCS with sham cTBS] | — |
Countries
India
Contacts
Public ContactVenkatasubramanian Ganesan
National Institute of Mental Health and Neurosciences
Outcome results
None listed