Health Condition 1: F20- Schizophrenia
Conditions
Interventions
Intervention1: Prefrontal intermittent Theta Burst Stimulation (iTBS): Real iTBS is delivered to left dorsolateral prefrontal cortex (DLPFC) and sham iTBS to cerebellar vermis area 7B.
1800 pulses of
Sponsors
National Institute of Mental Health and Neurosciences NIMHANS
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with schizophrenia as per Diagnostic and Statistical Manual â?? 5 (DSM-5) (American Psychiatric Association, 2013) criteria, aged 18-60 years of either sex will be recruited from the outpatient and inpatient settings of the National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru, India. 2. At least one of the domains of negative symptoms should be at least of a moderate severity as indicated by Scale for Assessment of Negative Symptoms (SANS) global score of 3 or more on affective flattening OR alogia OR avolition-apathy OR anhedonia-asociality (Andreasen et al., 2005) 3. Stable dose of oral antipsychotics (defined as <25% change in dose) for the past 6 weeks and/or parenteral antipsychotics for the past 12 weeks
Exclusion criteria
Exclusion criteria: 1. Significant neurological or medical disorders that may produce cognitive impairment 2. Substance abuse or dependence (except nicotine) within the past 3 months 3. Persistent suicidal or homicidal behavior 4. Pregnant, lactating or in the postpartum state 5. Self-reported visual or auditory impairment that may interfere with study evaluations 6. Risk factors for TMS procedures and/or MRI as assessed by standard questionnaires (Ghadimi & Sapra, 2020; Rossi et al., 2011)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scale for the Assessment of Negative symptoms (SANS)Timepoint: Baseline, Week-3 (after 18 days of intervention), Week-12 (after 3 months of intervention) | — |
Secondary
| Measure | Time frame |
|---|---|
| Glu and GABA/Glu in Left DLPFC, right DLPFC and Anterior Cingulate Cortex (ACC) through magnetic resonance spectroscopy (MRS). In 45 subjects (15 in each arm) only.Timepoint: Baseline, Week-3 (after 18 days of intervention);Resting State Functional Connectivity (RSFC) between the target areas (vermis and left DPLFC) and different subdivisions of the prefrontal cortex.Timepoint: Baseline, Week-3 (after 18 days of intervention);Spectral power of TMS-evoked gamma band oscillations in the prefrontal cortex elicited through TMS-EEGTimepoint: Baseline, Week-3 (after 18 days of intervention);White matter integrity in the form of Fractional Anisotropy (FA) of the superior cerebellar peduncle, frontal lobar white matter, and corpus callosumTimepoint: Baseline, Week-3 (after 18 days of intervention) | — |
Countries
India
Contacts
Public ContactRakshathi Basavaraju
National Institute of Mental Health and Neurosciences (NIMHANS)
Outcome results
None listed