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Improving Apathy and Motivation in Schizophrenia Using a Novel Brain-Stimulation Method

Role Of Adjunctive Intermittent Theta Burst Stimulation Over Left Dorsolateral Prefrontal Cortex In Patients With Negative Symptoms Of Schizophrenia: A Randomized Double-Blind Sham Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099455
Enrollment
60
Registered
2025-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: F200- Paranoid schizophrenia

Interventions

Intervention1: Intermittent Theta Burst Stimulation, a form of repetitive transcranial magnetic stimulation: a) Stimulus intensity: 80% of Resting MT. b) Burst Frequency in train: 5 Hz c) Pulse Freq

Sponsors

IPGMER and SSKM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age between 18-65 years. Subjects meeting SCID-5-CV criteria which generates DSM 5 diagnosis for Schizophrenia and having at least 20 score on PANSS negative subscore scale with at least two items more than equal to 4, without showing a more than 20 percent response between pre-inclusion and inclusion visit. On antipsychotic medications at effective dosages for more than six weeks.

Exclusion criteria

Exclusion criteria: i. Current SCID-5-CV criteria which generates as per DSM 5- diagnosis of Severe depressive disorder, suicidal ideations, or any other psychotic disorder, or any other severe comorbid psychiatric illness, or substance use disorder. ii. Standard rTMS contraindications like history of epilepsy, metal implants near the head in any part of the body, history of neurosurgical operations , pacemaker implant, evaluated using TMS adult safety screen (TASS) questionnaire. iii. Concurrent use of medications or drugs that are known to reduce the seizure threshold. iv. Acute or chronic debilitating physical illness. v. Pregnancy or lactation. vi. Subjects with intellectual disabilities.

Design outcomes

Primary

MeasureTime frame
TO COMPARE AND ASCERTAIN THE ROLE OF ADJUNCTIVE INTERMITTENT THETA BURST STIMULATION OVER LEFT DORSOLATERAL PREFRONTAL CORTEX IN PATIENTS WITH NEGATIVE SYMPTOMS OF SCHIZOPHRENIATimepoint: baseline and 7,14,28 and 60 days from the end of intervention

Secondary

MeasureTime frame
to ascertain whether itbs is a safe & well tolerated regimen for patients with schizophreniaTimepoint: baseline & 7,14,28 & 60 days from the end of intervention

Countries

India

Contacts

Public ContactGourab Bhattacharya
sujitsarkhel@gmail.com9836074700

Outcome results

None listed

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