Effect of brainâ??s ability to change itself with brain stimulation (tDCS) treatment among Schizophrenia patients who hear voices
Not Applicable
- Conditions
- Health Condition 1: F20- Schizophrenia
- Registration Number
- CTRI/2020/12/029667
- Lead Sponsor
- Department of Psychiatry National Institute of Mental Health And Neuro Sciences NIMHANS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) NEUROPHYSIOLOGICAL MEASURES: Change in N100 amplitude assessed by event-related potential (ERP) paradigms <br/ ><br>2) NEURO-CHEMICAL MEASURE: Change in glutamate-glutamine (Glx) levels in frontal and temporal areas of the brain <br/ ><br>3) NEURO-HAEMODYNAMIC MEASURE: Increase in resting state functional connectivity of left temporo-parietal junction with left pre-frontal cortex <br/ ><br>4) CLINICAL MEASURE: Reduction in Auditory Hallucination Rating Scale (AHRS) ScoreTimepoint: Pre RCT <br/ ><br>Post Single-session tDCS (Neurophysiological measure only) <br/ ><br>Post RCT
- Secondary Outcome Measures
Name Time Method 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. <br/ ><br>Timepoint: 1-month follow-up <br/ ><br>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 <br/ ><br>Post RCT;Identifying biographic and disorder-related features that influence neuroplasticity modulation using machine learning approaches.Timepoint: Post RCT <br/ ><br>One-month follow-up