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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 socialization

Intermittent Theta Burst Stimulation (iTBS) of Cerebellar Vermis in Schizophrenia: Impact on Negative Symptoms and Brain Connectivity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/09/009636
Enrollment
60
Registered
2017-09-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Schizophrenia

Interventions

Intervention1: Intermittent Theta Burst Stimulation: Two sessions per day spaced four hours apart Control Intervention1: Sham Transcranial Magnetic Stimulation: Simulation of Transcranial magnetic sti

Sponsors

Rakshathi Basavraju
Lead Sponsor
Dr Muralidharan K
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)—

Countries

India

Contacts

Public ContactRakshathi Basavaraju

NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES

rakshathi.b@gmail.com9900787730

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026