跳至主要内容
临床试验/CTRI/2021/07/035267
CTRI/2021/07/035267已完成不适用

Adjunctive Deep Transcranial Magnetic Stimulation (dTMS) for treatment of negative symptoms in schizophrenia A randomised sham controlled h-MRS study

Central Institute of Psychiatry1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年1月8日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Primary outcome of this study is the change in negative symptoms score as assessed at the end of 2 weeks

研究概览

简要总结

Negativesymptoms are important when it comes to prognosis and outcomes ofschizophrenia. Both typical and atypical antipsychotics have shown limitedeffectiveness in modifying the psychopathology of negative symptoms.Hypo-activation of the ACC are found in neuroimaging studies of schizophrenia.It could be that an abnormal ACC in schizophrenia is unable to activate furtherin response to increasing task demands (Adams and David, 2007; Bersani et al., 2014). Manoach (2003) has described this relationshipin the dorsolateral prefrontal cortex (DLPFC) in schizophrenia, and relatestask-related DLPFC hypoactivity to decreased task performance. Considering thehypoactivity in these parts in schizophrenia, particularly with negativesymptoms, activation of these structure can lead to the improvement in innegative symptoms, as reported by Dlabac-de Langeet al in 2010, where they reported a significant superiority of active rTMS(DLPFC) over sham to reduce negative symptoms of schizophrenia (Dlabac-de Langeet al., 2010). Moreover, negative symptoms are related to specificneuroanatomical changes specially to mPFC and ACC. Compared to conventionalmethod of TMS, dTMS have an advantage of stimulating deeper structures. Resultsof studies using dTMS for the treatment of negative symptoms and cognitivedeficits have shown a positive therapeutic effect when used as an adjunct toantipsychotic agents. In a study seventy percent of patients who completedtreatment were responders, having achieved >20% improvement in negativesymptoms. (Levkovitz et al.,2011). To the best of our knowledge, there has beenno study assessing the effects of dTMS in negative symptoms of schizophrenia asmeasured by H-MRS findings of mPFC and ACC.

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

  • Diagnosis of Schizophrenia using Diagnostic Criteria for Research (DCR) of International Classification of Disease-10th edition (ICD-10, World Health Organization, 1992).
  • Age between 18- 60 years of either sex.
  • Illness duration of equal to or more than 2 years.
  • The Positive and Negative Syndrome Scale for Schizophrenia (PANSS) negative symptoms score of more than
  • Scale for Assessment of Negative Symptoms (SANS) score more than
  • Right-handed.
  • Patients giving written informed consent.

排除标准

  • Presence of co-morbid neurological or other psychiatric disorder(s).
  • Patient with co morbid substance dependence, except nicotine and caffeine.
  • Having any metallic implants/parts in body.8
  • Subjects who have received ECT in past 6 months.

结局指标

主要结局

Primary outcome of this study is the change in negative symptoms score as assessed at the end of 2 weeks

时间窗: Primary outcome of this study is the change in negative symptoms score as assessed at the end of 2 weeks | of dTMS treatment.

of dTMS treatment.

时间窗: Primary outcome of this study is the change in negative symptoms score as assessed at the end of 2 weeks | of dTMS treatment.

次要结局

  • Secondary outcomes are changes in the levels of GABA, Glutamate, Glutamine, N-Acetyl Aspartate & N-Acetyl Aspartyl Glutamate in Medial Prefrontal Cortex and Anterior Cingulate Cortex using Proton MR Spectroscopic imaging and overall severity scores on CGI.(Secondary outcomes are changes in the levels of GABA, Glutamate, Glutamine, N-Acetyl Aspartate & N-Acetyl Aspartyl Glutamate in Medial Prefrontal Cortex and Anterior Cingulate Cortex using Proton MR Spectroscopic imaging and overall severity scores on CGI, will be assessed at end of 2 weeks of dTMS treatment.)

研究者

申办方类型
Government medical college

研究点 (1)

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