CTRI/2025/10/096632
尚未招募
2/3 期
Efficacy of accelerated intermittent theta burst stimulation (iTBS) on negative symptoms among individuals with Schizophrenia: A randomised sham controlled study
Sir Sunderlal Hospital1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年11月15日最近更新:
概览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- Sir Sunderlal Hospital
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- 1.To assess the efficacy of accelerated intermittent theta burst stimulation in negative symptoms of patients with schizophrenia
概览
简要总结
Study design - Randomized controlled trial, with study topic of EFFICACY OF ACCELERATED INTERMITTENT THETA BURST STIMULATION (iTBS) ON NEGATIVE SYMPTOMS AMONG INDIVIDUALS WITH SCHIZOPHRENIA: A RANDOMISED SHAM CONTROLLED STUDY, being carried out in department of Psychiatry, IMS BHU Varanasi with sample size of 82 cases including accelerated iTBS protocol for 2 weeks with pre and post interventional assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Diagnosis of schizophrenia using diagnostic criteria of international classification of disease- 11th edition (ICD-11) 2.Male or female of age between 18 years to 60 years 3.Schizophrenia patients who haven’t received rTMS or ECT in the past 6 months 4.The Positive and negative syndrome scale for schizophrenia- negative symptoms score of more than 15 5.Scale for assessment of negative symptoms score more than 20 6.Willingness to give informed consent.
排除标准
- •1.Presence of comorbid neurological, medical or other psychiatric disorder that are interfering with the study or patient being unmanageable due to acute illness or severity of the existing disorder 2.Patients with comorbid substance dependence, except nicotine and caffeine 3.Having any metallic implants/parts in body 4.Patients having a history of head trauma with loss of consciousness 5.Patients with a history of seizure/convulsion or having epilepsy or family history of same.
- •6.Patients with raised intracranial tension 7.Patients with a history of neurosurgery of any type ( brain or spinal cord).
结局指标
主要结局
1.To assess the efficacy of accelerated intermittent theta burst stimulation in negative symptoms of patients with schizophrenia
时间窗: Baseline and 2 weeks
2.To compare the efficacy of accelerated intermittent theta burst stimulation in negative symptoms of schizophrenia patients with that of the control group
时间窗: Baseline and 2 weeks
次要结局
- To assess the efficacy of accelerated intermittent theta burst stimulation in positive symptoms of patients with schizophrenia(To compare the efficacy of accelerated intermittent theta burst stimulation in positive symptoms of schizophrenia patients with that of the control group)
- To assess the efficacy of accelerated intermittent theta burst stimulation in cognitive functions of patients with schizophrenia(To compare the efficacy of accelerated intermittent theta burst stimulation in cognitive functions of schizophrenia patients with that of the control group)
- To assess the safety and tolerance of accelerated iTBS in patients with schizophrenia(Baseline, 1 week and 2 weeks)
研究者
Dr Vaishnavi Raj
Institute of medical sciences, BHU
研究点 (1)
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