EFFECTIVENESS OF MAGNETIC STIMULATION OF BRAIN FOR TREATING HEARING OF VOICES IN SCHIZOPHRENIA

Not Applicable

Completed

• Conditions: Health Condition 1: F202- Catatonic schizophreniaHealth Condition 2: F201- Disorganized schizophreniaHealth Condition 3: F208- Other schizophreniaHealth Condition 4: F200- Paranoid schizophreniaHealth Condition 5: F205- Residual schizophreniaHealth Condition 6: F209- Schizophrenia, unspecifiedHealth Condition 7: F203- Undifferentiated schizophrenia

• Registration Number: CTRI/2020/12/029506
• Lead Sponsor: SRI GURU RAM RAI INSTITUTE OF MEDICAL AND SCEINCES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-09-25
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 59

Inclusion Criteria

1.) Patients must fulfill the diagnostic criteria of schizophrenia as per ICD-10 DCR (Diagnostic criteria for research).

2.) Age: between 18-59 years.

3.) Right-handed patients.

4.) Severity of AVH: score of 3 or more according to Positive and Negative Syndrome Scale (PANSS).

5.) Inadequate response (remission of AVH) to at least one antipsychotic drug at maximally tolerated dose, which is within the recommended therapeutic range, in trials lasting 6 weeks or more.

6.) Stable antipsychotic medication 4 weeks before and during the continuous theta burst transcranial magnetic stimulation treatment.

Exclusion Criteria

1.) History suggestive of brain injury or surgery.

2.) Any significant brain malformation/neoplasm.

3.) Neurodegenerative disorder or history of seizures.

4.) History of ECT within the past 6 months.

5.) Pacemakers of other metal parts in the body.

6.) Diagnosis of mental and behavioural disorder due to use of psychoactive substances harmful use or dependence (except nicotine and caffeine).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For assessing improvement in auditory verbal hallucinations and therapeutic response, following scales to be used-PANSS(positive and negative syndrome scale) <br/ ><br>AVHRS(auditory vocal hallucination rating scale) <br/ ><br>PSYRATS-AH(psychotic symptom rating scales- auditory hallucinations scale) <br/ ><br>CGI(clinical global impression) <br/ ><br>Timepoint: PANSS, AVHRS, PSYRATS-AH and CGI ratings will be applied at the beginning of TMS, end of TMS and post 2 weeks of TMS (i.e. baseline, 15th day and 30th day).

Secondary Outcome Measures

Name	Time	Method
CDSS(calgary depression scale for schizophrenia) for assessing level of depression in schizophrenia. <br/ ><br>SCoRS(schizophrenia cognition rating scale manual) for evaluation of cognitive deficits in schizophrenia. <br/ ><br>Timepoint: CDSS and SCoRS ratings will be applied at the beginning of TMS, end of TMS and post 2 weeks of TMS (i.e. baseline, 15th day and 30th day).