Examining Neuroplasticity modulation as mechanistic basis of tDCS treatment effects on Auditory Verbal Hallucination in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 1) NEUROPHYSIOLOGICAL MEASURES: Change in N100 amplitude assessed by event-related potential (ERP) paradigms
研究概览
简要总结
20-30% schizophrenia (SCZ) patients struggle with auditory verbal hallucinations (AVH) minimally responsive to pharmaceutical treatments. Add-on fronto-temporoparietal transcranial direct current stimulation (tDCS) is suggested to address persistent AVH in SCZ patients. High heterogeneity among existing randomized control trials for AVH treatment in SCZ and lack of empirical studies investigating tDCS action mechanism warrants a systematic investigation into the mechanistic basis of tDCS action.
This study proposes and examines the brain’s neuroplasticity potential as biological phenomena driving treatment effects of tDCS. Using a randomized, double-blind, sham-controlled parallel-arm, pre-post design, changes in neuroplasticity potential with tDCS treatment for AVH in SCZ will be assessed. The four composite primary outcome measures of this study are:
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changes in N100-derived event-related-potential waveforms (neurophysiological),
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changes glutamine-glutamate levels (neurochemical),
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changes in resting-state functional connectivity (neuroimaging), and
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reduction in AVH severity (clinical).
Secondary objectives of this study are:
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exploring the correlation between neurobiological measures of neuroplasticity changes induced by tDCS and clinical improvement in AVH to indicate the nature and strength of the relationship between the two;
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exploring the effect of verum (active) tDCS on early course versus late course SCZ patients will uncover if illness chronicity is a potential barrier to tDCS responsivity; and
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utilizing disorder-related (age at illness onset, medication, the severity of the symptom, etc.) and biographic (age, sex, years of education, etc.) features of the study sample towards predicting neuroplasticity modulation in the study sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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
- •Diagnosis of schizophrenia DSM-5 (American Psychiatric Association, 2013) 2) Clinically Significant Auditory Verbal Hallucinations despite adequate antipsychotic treatment 3) Right Handedness 4) Written informed consent.
排除标准
- •Features suggestive of psychiatric emergency 2) Any contraindication to MRI or tDCS procedures 3) Any co-morbid psychiatric diagnosis 4) Pregnancy or post-partum status 5) Left/Mixed Handedness.
结局指标
主要结局
1) NEUROPHYSIOLOGICAL MEASURES: Change in N100 amplitude assessed by event-related potential (ERP) paradigms
时间窗: Pre RCT | Post Single-session tDCS (Neurophysiological measure only) | Post RCT
2) NEURO-CHEMICAL MEASURE: Change in glutamate-glutamine (Glx) levels in frontal and temporal areas of the brain
时间窗: Pre RCT | Post Single-session tDCS (Neurophysiological measure only) | Post RCT
3) NEURO-HAEMODYNAMIC MEASURE: Increase in resting state functional connectivity of left temporo-parietal junction with left pre-frontal cortex
时间窗: Pre RCT | Post Single-session tDCS (Neurophysiological measure only) | Post RCT
4) CLINICAL MEASURE: Reduction in Auditory Hallucination Rating Scale (AHRS) Score
时间窗: Pre RCT | Post Single-session tDCS (Neurophysiological measure only) | Post RCT
次要结局
- Clinical follow-up in schizophrenia patients with ≥25% reduction in auditory hallucination severity at post tDCS time point, at 1 month and 3 months after termination of tDCS.
- Effect of illness duration on tDCS treatment response in early course (duration of illness ≤2 years) and late course (duration of illness ≥5 years) schizophrenia patients.(Pre RCT)
- Identifying biographic and disorder-related features that influence neuroplasticity modulation using machine learning approaches.(Post RCT)