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Adjunctive Intermittent Theta Burst Transcranial Magnetic Stimulation (iTBS) of Medial Prefrontal Cortex in Patients with Deficit Schizophrenia.

Adjunctive Intermittent Theta Burst Transcranial Magnetic Stimulation (iTBS) of Medial Prefrontal Cortex in Patients with Deficit Schizophrenia: A Sham Controlled fNIRS Study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052347
Enrollment
40
Registered
2023-05-08
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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(iTBS), active: For medial prefrontal cortex stimulation,the deep iTBS coil will be placed over the site of stimulation ,coil position would be deter

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.Aged between 18- 60 years, right-handed individuals of either sex. 3.An illness of duration more than 2 years & on stable dose of antipsychotics. 4.Patients with significant deficit syndrome [Based upon PANSS, one can assess deficit syndrome by using a formula [(blunted affect + emotional withdrawal) - (anxiety+ guilt feelings + depressive mood + hostility)]. A cut-off point of more than â?? 2 will be used to categorize the deficit group[Gard et al.,2006]. This method is also known as Proxy deficit syndrome (PDS) criteria] 5.Scale for Assessment of Negative Symptoms (SANS) score more than 20. 6.Calgary Depression Scale for Schizophrenia (CDSS) score less than 7. 7.Patients giving written informed consent.

Exclusion criteria

Exclusion criteria: 1.Presence of comorbid neurological or other psychiatric disorder(s). 2.Patients with comorbid substance dependence in the last 6 months, except nicotine and caffeine. 3.Subjects who have received ECT/ any other neuromodulation in the past one months. 4.Patients with contraindications to iTBS like pacemakers, metallic implants etc.

Design outcomes

Primary

MeasureTime frame
Changes in scores of PANSS,SANS,TEPS,RSAS,SCS,CGI-SCH.Timepoint: Baseline, 1 week, 3 week

Secondary

MeasureTime frame
Changes on fNIRS in specified brain areasTimepoint: Baseline, 1 week

Countries

India

Contacts

Public ContactDr Umesh S

Central Institute of Psychiatry

umesh.yes@hotmail.com9771702403

Outcome results

None listed

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