“Effect of Neuromodulation on Ipseity Encoding in Schizophrenia Patients withPersistent Auditory Hallucinations: Neurocognitive, Neurophysiological & NeuroimagingStudiesâ€
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- To assess the neuromodulatory effect of cTBS and tDCS (Neuromodulation) on ipseity encoding(measured by DIFFERENCE OF N100 amplitude between talk and listen condition) and source monitoring deficit(P300 amplitude measured during source monitoring task) in patients with persistent auditory hallucination with schizophrenia via specific event related potential(ERP) parameters
研究概览
简要总结
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The trial is a part of PhD work jointly conducted at the Central Institute of Psychiatry (CIP), Ranchi and NIMHANS, Bengaluru.
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The PhD has been registered at NIMHANS. The data collection would happen at CIP and training and guidance will be provided by the mentors from both NIMHANS and CIP.
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The funding for the work has been provided by DBT-Wellcome trust, India Alliance.
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The patients recruited under the trial "Clinical Research Centre for Neuromodulation in Psychiatry" study2 (CTRI registration number - CTRI/2021/05/033783) will be exposed to additional ERP experiments to collect the requisite data.
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No separate intervention would be provided to the study sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Schizophrenia Diagnosis according to the DSM-5
- •Age 18-45 years;
- •Right-Handedness using Edinburgh Handedness Inventory
- •Persistence of auditory hallucinations without remission despite treatment with at least one antipsychotic medication at an adequate dose for a minimum duration of six weeks.
- •(Non-remission is defined as a score of moderate or high (>2) on the Global Rating of Hallucinations in the scale for the assessment of positive symptoms (SAPS)
- •Ability to provide written informed consent.
排除标准
- •Psychiatric emergency necessitating electroconvulsive therapy;
- •Suicidal risk / any psychiatric emergency;
- •Score of > 6 on Calgary Depression Rating Scale (Addington et al.,1994);
- •Pregnancy / Post-Partum;
- •substance use disorder in last six months (except caffeine ornicotine);
- •Co-morbid neurological / medical disease that can affect the brain structure / function.
- •Any Contraindication for Magnetic Resonance Imaging;
- •Any Contraindication for Transcranial Magnetic Stimulation.
- •Any Contraindication for Transcranial Direct Current Stimulation.
- •Hearing impairment
- •History of significant head injury (loss of consciousness more than30 minutes or any permanent sequelae).
结局指标
主要结局
To assess the neuromodulatory effect of cTBS and tDCS (Neuromodulation) on ipseity encoding(measured by DIFFERENCE OF N100 amplitude between talk and listen condition) and source monitoring deficit(P300 amplitude measured during source monitoring task) in patients with persistent auditory hallucination with schizophrenia via specific event related potential(ERP) parameters
时间窗: The effect will be determined by assessing the ERP parameters at 2 time points: before neuromodulation treatment and after 15 days of neuromodulation treatment.
次要结局
- 1.To compare the ipseity monitoring ERPs in schizophrenia patients with medicationresistant persistent auditory hallucination with that of matched healthy control.(2. To compare the relative improvement of ipseity monitoring ERPs in schizophrenia patients with medication-resistant persistent auditory hallucination after cTBS TMS and tDCS intervention.)