Impact of a new kind of delivery of magnetic pulses to the brain called intermittent Theta Burst Stimulation for hind part of the human brain cerebellum for negative symptoms in schizophrenia which are reduced speech, drive for activities and pleasure, emotional expression and socializatio
- Conditions
- Health Condition 1: null- Schizophrenia
- Registration Number
- CTRI/2017/09/009636
- Lead Sponsor
- Rakshathi Basavraju
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1. DSM 5 diagnosis of schizophrenia as confirmed by two clinicians independently
2. Medications unchanged at least for the last 3 months and no ECT prescribed in the last 6 months
3. SANS (Scale for Assessment of Negative Symptoms) score of 3 or more on items of global ratings of Affective flattening, Alogia, Avolition-Apathy, Anhedonia-Asociality.
1. To avoid confounders likely to affect cognition or treatment response, participants should meet the following criteria
(i) Absence of significant neurological or medical disorders that may produce cognitive impairment (e.g., seizure disorder, traumatic brain injury) as assessed during clinical interview
(ii) Absence of a recent (within the past 3 months) history of substance abuse or dependence (except nicotine)
(iii) Absence of persistent suicidal or homicidal behavior
(iv) Absence of pregnancy, lactation and postpartum state
(vi) Absence of self reported visual or auditory impairment that can impede cognitive assessments.
2. To minimize TMS-related complications, subjects fulfilling any of the risk factors for TMS procedures as assessed using Transcranial Magnetic Stimulation Adult Safety Screen (Keel, Smith, and Wassermann 2001) will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in negative symptoms and cognitive status compared to baselineTimepoint: Baseline, day 6 (5 days after treatment) and 6th week after initiation of treatment
- Secondary Outcome Measures
Name Time Method Increased connectivity within the dorsal attention network (middle frontal gyrus and superior parietal lobule) as examined using resting state functional magnetic resonance imaging.Timepoint: Baseline and day 6 (5 days after treatment)