Research study on brain stimulation for auditory hallucinations in schizophrenia.

Not Applicable

• Conditions: Health Condition 1: F20- Schizophrenia

• Registration Number: CTRI/2021/05/033783
• Lead Sponsor: Department of Psychiatry National Institute of Mental Health and Neuro Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Resting state functional brain connectivityTimepoint: Time Point-1 (T1): Baseline-1 (i.e before part-1 intervention) <br/ ><br>Time Point-2 (T2): After 15 days of part-1 intervention [true cTBS with sham tDCS (OR) true c-tDCS with sham cTBS] <br/ ><br>Time Point-3 (T3): Baseline-2 (i.e. before part-2 intervention) <br/ ><br>Time Point-4 (T4): After 15 days of part-2 intervention [true cTBS with sham tDCS (OR) true c-tDCS with sham cTBS]