Health Condition 1: G- Mental Health
Conditions
Interventions
Intervention1: Transcranial Magnetic Stimulation: Intermittent theta burst stimulation, a type of patterned TMS, will be administered to the cerebellar vermis. A MagPro X100 device will be used to del
three pulses per burst at 50 Hz
with 120% resting motor threshold using an active-placebo double cone coil (MagVenture, Farum, Denmark). The double-cone coil will be centered over the posterior midline cerebellum. The precise locati
Sponsors
Narmadanagar Rural Development Society (NARDES), the CSR arm of GNFC, Gujarat
Eligibility
Inclusion criteria
Inclusion criteria: - Patients meeting the diagnostic criteria for schizophrenia (using the Diagnostic Criteria for Research (DCR) of International Classification of Diseases – tenth edition (ICD10) will be approached SELECTION CRITERIA - Illness duration - Those patients who (a) have been diagnosed with schizophrenia for the first time and initiated on treatment with first-line antipsychotic medications or (b) have had a relapse of symptoms following drug default of > 2months and are being restarted on antipsychotic medications - Marked or higher symptom severity as defined by the clinical global impression (schizophrenia) score of 5 or more - Age: 18 to 55 years - Any gender - Having the capacity to provide consent as assessed using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA- - Prior history of seizure - Patients with severe agitation, catatonia, and suicidal risk who may require emergency treatment with rescue medications and/or electroconvulsive therapy (ECT) - Patients with a documented history of resistance or non-response to an adequate antipsychotic trial - Clinical diagnosis of a comorbid neurological disorder - Clinical diagnosis of comorbid substance dependence, except nicotine, in the past 6 months from recruitment - Currently pregnant or postpartum - Contraindications for going through TMS (e.g., intracranial implants) or MRI (e.g., metallic implants) as assessed using TMS adult safety screen and MRI checklist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of symptom improvementTimepoint: At the end of treatment (6d) and at 4-8w | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of symptom improvementTimepoint: At 12-16w and 20-24w from recruitment;safety and tolerabilityTimepoint: After each TMS treatment session;Speed of treatment response - time to remission (CGI score 3 or less)Timepoint: At 4-8 weeks | — |
Countries
India
Contacts
Public ContactUrvakhsh Meherwan Mehta
National Institute of Mental Health and Neurosciences
Outcome results
None listed