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

IPGMER and SSKM Hospital1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2025年12月29日最近更新: 2025年12月18日

试验速览

阶段: 2 期
状态: 尚未招募
发起方
入组人数: 60
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

Our study provides evidence that left DLPFC stimulation can significantly reduce negative symptoms in schizophrenia, with statistically significant results. The results reinforce the role of neuromodulation as an adjunctive treatment in schziophrenia and highlight the need for further research to optimise stimulation parameters and patient selection criteria. These findings contribute to the growing body of literature supporting non- invasive brain stimulation techniques in psychiatric disorders and underscore the need for continued exploration of individualised neuromodulation strategies in schizophrenia treatment.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant and Outcome Assessor Blinded

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•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.

排除标准

•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.
•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.
•Concurrent use of medications or drugs that are known to reduce the seizure threshold.
•Acute or chronic debilitating physical illness.
•Pregnancy or lactation.
•Subjects with intellectual disabilities.

研究者

发起方

IPGMER and SSKM Hospital

申办方类型

Research institution and hospital

责任方

Principal Investigator

主要研究者

Gourab Bhattacharya

IPGMER and SSKM Hospital

研究点 (1)

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