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Alteration of nerve activity in schizophrenia patients with deficits in empathy by additional iTBS over treatment as seen on changes in EEG activity in response to observed biological motion

Neuromodulatory effects of adjuvant iTBS on EEG Mu wave suppression in response to observed biological motion in schizophrenia patients with deficits in empathy - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/054966
Enrollment
40
Registered
2023-07-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Health Condition 1: F20- Schizophrenia

Interventions

Intervention1: Intermittent theta burst stimulation: Intermittent theta burst stimulation will be been performed by using a double-cone coil placed at 1.5cm above the nasion thus, targeting the Medial

Sponsors

Central Institute of Psychiatry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis of Schizophrenia using Diagnostic Criteria for Research (DCR) of International Classification of Disease-10th edition (ICD-10, World Health Organization,1993). 2. Age between 18-60 years of either sex. 3. Right-handed. 4. On stable dose of any antipsychotic medication (Chlorpromazine equivalent dosage at least 600mg per day for past 2 weeks) 5. Patients giving written consent. 6. Calgary Depression Scale for Schizophrenia (CDSS) score less than 7. 7. The Positive and Negative Syndrome Scale for Schizophrenia (PANSS) has, negative symptoms score of more than 15 and a positive score of less than 11. 8. Patients with deficits in empathy defined as scores on Interpersonal Reactivity Index (more than the respective means) for the 4 domains, namely Fantasy, Perspective Taking, Empathic Concern, Personal Distress

Exclusion criteria

Exclusion criteria: 1. Presence of co-morbid neurological or other psychiatric disorder(s). 2. Patient with co-morbid substance dependence, except nicotine and caffeine. 3. Subjects who have received ECT in the past 6 months. 4. Not willing to give informed consent.

Design outcomes

Primary

MeasureTime frame
Reduction in scores of symptoms of schizophrenia as rated by Positive & Negative Syndrome Scale (PANSS) and increase in scores of Interpersonal Reactivity Index (IRI) Timepoint: After completion of iTBS sessions i.e. 10 days after initiation of treatment & 4 weeks thereafter.

Secondary

MeasureTime frame
Changes in EEG mu wave suppression in response to observed biological motion in schizophrenia patients with deficits in empathyTimepoint: At completion of iTBS sessions i.e. 10 days after initiation of treatment

Countries

India

Contacts

Public ContactDr Sanjay Kumar Munda

Central Institute of Psychiatry

drsanjaymunda@gmail.com8797641082

Outcome results

None listed

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