Giving Magnetic therapy a type of Brain Stimulation to Help People with Schizophrenia with Their Thinking and speech.

Phase 3

Conditions: Health Condition 1: F20- Schizophrenia

Registration Number: CTRI/2024/03/063549

Lead Sponsor: Dr Pratima Murthy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Patients with schizophrenia with capacity to consent.

2. Age range: 18 – 45 years

3. Patients with schizophrenia exhibiting cognitive deficits, defined as BACS scores (any domain) falling 1 or more standard deviations below the mean and standard deviation derived from a local healthy population cohort.

4. Right handed individuals assessed by Edinburgh Handedness scale.

5. Having moderate level of symptoms as measured by a score of 4 or more on Global rating on any domains in SAPS or SANS scale.

6. No contraindication for MRI and TMS (as assessed by TASS checklist)

7. No risk of harm to self or harm to others

8. No active substance use in the last 3 months (apart from nicotine).

Exclusion Criteria

1. Features suggestive of risk of harm to self (for example: suicidal risk, catatonia, prolonged nutritional deprivation) or others (for example: aggression or excitement)

2. Unstable medical condition

3. History of uncontrolled seizures

4. Co morbid medical or neurological disorder that can affect structure of the brain.

5. Pregnancy or postpartum state

6. Comorbid substance abuse or dependence

7. Significant neurologic disorder

8. Any contraindication for MRI & TMS

9. Left/mixed Handedness

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Verbal fluency Test scores.Timepoint: Time point 1 (T1)- Baseline <br/ ><br>Time point 2 (T2)- End of intervention of the study i.e End of 10th session (5DAYS) or termination of the trial for any predefined reasons)

Secondary Outcome Measures

Name	Time	Method
1. Scale for the Assessment of Positive Symptom (SAPS) <br/ ><br>2. Scale for the Assessment of Negative Symptom (SANS) <br/ ><br>3. Brief Psychiatric Rating Scale (BPRS). <br/ ><br>4. Clinical Global Impressions (CGI) Scale <br/ ><br>5. Brief Assessment of Cognition in Schizophrenia (BACS) <br/ ><br>6. Social and Occupational Functioning Assessment Scale (SOFAS) <br/ ><br>7. NLP (Natural Language Processing) metrics derived from recorded speech interview. <br/ ><br>8. Brain magnetic imaging measures <br/ ><br>(structural image, task based functional images, resting-state functional images, diffusion tensor images, glutamate levels at left anterior temporal cortex from MR spectroscopy) <br/ ><br>9. TMS- Electroencephalography measures at Baseline. <br/ ><br>Timepoint: Time point 1 (T1)- Baseline <br/ ><br>Time point 2 (T2)- End of intervention of the study i.e End of 10th session (5DAYS) or termination of the trial for <br/ ><br>any predefined reasons)