Intermittent Theta Burst Stimulation (iTBS) of Cerebellar Vermis in Schizophrenia: Impact on Negative Symptoms and Brain Connectivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in negative symptoms and cognitive status compared to baseline
研究概览
简要总结
Negative symptoms in schizophrenia are substantially disabling and difficult to treat necessitating novel treatment mechanisms. Theta Burst Stimulation (TBS) is a novel patterned repetitive transcranial magnetic stimulation (rTMS) technique whose safety and efficacy has been established in a small group of schizophrenia patients in an open label study, the target area being cerebellar vermis. The aims of our study is to examine the efficacy of iTBS (intermittent TBS) to the cerebellar vermis for negative symptoms in schizophrenia, to examine the resting state functional connectivity correlates of clinical improvement in negative symptoms and impact on cognitive deficits. The study will be conducted as a double-blind randomized controlled trial, where 60 patients of schizophrenia meeting inclusion and exclusion criteria will be randomized to intervention arm who will receive iTBS and control arm who will receive sham TMS (30 in each group). Assessments that will be carried out at baseline and periodically are positive and negative symptom severity, depressive symptoms, extrapyramidal symptoms, general cognition and social cognitive assessments, vital signs and cerebellar adverse effects. A resting state functional MRI as well as high resolution structural MRI will be obtained at baseline and at the end of the iTBS sessions. Patients will receive iTBS or sham-TMS for 5 days (two-sessions a day, four hours apart). The site of cerebellar stimulation will be guided by MRI guided Neuronavigation. Results will be analysed using mixed-model analysis of variance, correlational and regressional analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •DSM 5 diagnosis of schizophrenia as confirmed by two clinicians independently
- •Medications unchanged at least for the last 3 months and no ECT prescribed in the last 6 months
- •SANS (Scale for Assessment of Negative Symptoms) score of 3 or more on items of global ratings of Affective flattening, Alogia, Avolition-Apathy, Anhedonia-Asociality.
排除标准
- •To avoid confounders likely to affect cognition or treatment response, participants should meet the following criteria (i) Absence of significant neurological or medical disorders that may produce cognitive impairment (e.g., seizure disorder, traumatic brain injury) as assessed during clinical interview (ii) Absence of a recent (within the past 3 months) history of substance abuse or dependence (except nicotine) (iii) Absence of persistent suicidal or homicidal behavior (iv) Absence of pregnancy, lactation and postpartum state (vi) Absence of self reported visual or auditory impairment that can impede cognitive assessments.
- •To minimize TMS-related complications, subjects fulfilling any of the risk factors for TMS procedures as assessed using Transcranial Magnetic Stimulation Adult Safety Screen (Keel, Smith, and Wassermann 2001) will be excluded.
结局指标
主要结局
Improvement in negative symptoms and cognitive status compared to baseline
时间窗: Baseline, day 6 (5 days after treatment) and 6th week after initiation of treatment
次要结局
- Increased connectivity within the dorsal attention network (middle frontal gyrus and superior parietal lobule) as examined using resting state functional magnetic resonance imaging.(Baseline and day 6 (5 days after treatment))