Health Condition 1: F20- Schizophrenia
Conditions
Interventions
Intervention1: Verum tDCS (Transcranial Direct Current Stimulation): Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulatory technique that delivers low-intensity direct curre
electrode size: 35cm2]. For Verum-tDCS condition, 2-mA of constant current will be delivered for 20-minutes with additional ramp-up and ramp-down of 20 seconds each.
Control Intervention1: Sham tDCS (
electrode size: 35cm2]. Duration will be 20 minutes. However, no current will be delivered beyond ramp-up and ramp-down time of 20 ms.
Sponsors
Department of Psychiatry National Institute of Mental Health And Neuro Sciences NIMHANS
Eligibility
Inclusion criteria
Inclusion criteria: 1) Diagnosis of schizophrenia DSM-5 (American Psychiatric Association, 2013) 2) Clinically Significant Auditory Verbal Hallucinations despite adequate antipsychotic treatment 3) Right Handedness 4) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Features suggestive of psychiatric emergency 2) Any contraindication to MRI or tDCS procedures 3) Any co-morbid psychiatric diagnosis 4) Pregnancy or post-partum status 5) Left/Mixed Handedness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) NEUROPHYSIOLOGICAL MEASURES: Change in N100 amplitude assessed by event-related potential (ERP) paradigms 2) NEURO-CHEMICAL MEASURE: Change in glutamate-glutamine (Glx) levels in frontal and temporal areas of the brain 3) NEURO-HAEMODYNAMIC MEASURE: Increase in resting state functional connectivity of left temporo-parietal junction with left pre-frontal cortex 4) CLINICAL MEASURE: Reduction in Auditory Hallucination Rating Scale (AHRS) ScoreTimepoint: Pre RCT Post Single-session tDCS (Neurophysiological measure only) Post RCT | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical follow-up in schizophrenia patients with â?¥25% reduction in auditory hallucination severity at post tDCS time point, at 1 month and 3 months after termination of tDCS. Timepoint: 1-month follow-up 3-month follow-up;Effect of illness duration on tDCS treatment response in early course (duration of illness â?¤2 years) and late course (duration of illness â?¥5 years) schizophrenia patients.Timepoint: Pre RCT Post RCT;Identifying biographic and disorder-related features that influence neuroplasticity modulation using machine learning approaches.Timepoint: Post RCT One-month follow-up | — |
Countries
India
Contacts
Public ContactAnushree Bose
NIMHANS
Outcome results
None listed