Effectiveness of Navigated Transcranial Magnetic Stimulation (nTMS) of Left Supramarginal Gyrus for Negative Symptoms : A Double-blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Positive and Negative Symptom Scale (PANSS) score
研究概览
简要总结
This research aims to test the effectiveness of Navigated transcranial magnetic stimulation (nTMS) of left Supramarginal Gyrus for negative symptoms. In this double-blind, randomized controlled trial, patients will be assigned to active iTBS experimental group or sham iTBS group. Treatment will last for 10 days, and data will be collected at baseline, 1 day and 1 month after treatment.
详细描述
This research aims to test the effectiveness of Navigated transcranial magnetic stimulation (nTMS) for negative symptoms in patients with schizophrenia. In this double-blind, randomized controlled trial, patients will be assigned to active iTBS experimental group or sham iTBS group. By using the TMS Navigation System, the iTBS will be targeted at the left Supramarginal Gyrus, and parameters are set to triplet 50Hz bursts, repeat at 5Hz, 2s seconds on and 8 seconds off, 1800 pulses per session, intensity of 90% resting motor threshold(RMT), total duration of 10 minutes.Both group will receive nTMS 5 times a day, total treatment for 10 days. Measurements included a pretreatment measurement session, 10 days of nTMS treatment, a post-treatment measurement, and a follow-up measurement 1 month after treatment. At baseline, data of demographic variables (such as sex, age, years of education, occupational status, social support) and disease characteristics (such as duration of illness, antipsychotic daily dose in chlorpromazine equivalents, family psychiatric history) will be collected.At baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7) , data of outcomes (such as Positive and Negative Symptom Scale (PANSS) score,Negative Symptoms(SANS) score and other secondary outcomes) will be collected in order to test the effectiveness of nTMS. After completing the 1 month follow-up, patients may choose whether to continue follow-up , in order to observe the long-term effects of the treatment. However, they will not receive any further experimental interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Clinical diagnosis of schizophrenia according to ICD-
- •2.Confirmation of the diagnosis of schizophrenia using the SCID-5-RV (DSM-5 Structured Clinical Interview for DSM-5 Disorders - Research Version).
- •3.Score more than 4 points on either item of negative symptoms (N1-N7).
- •4.Aged less than 60 years.
排除标准
- •1.Clinical diagnosis or SCID-5-RV assessment confirming neurodevelopmental disorders, bipolar and related disorders, substance use disorders (excluding alcohol and tobacco).
- •2.Presence of severe or acute physical illnesses, including traumatic brain injury, intracranial space-occupying or infectious diseases, acute cardiovascular diseases, acute respiratory system diseases, acute hematological disorders, etc.
- •3.Presence of clearly defined genetic diseases, including tuberous sclerosis, multiple sclerosis, Kleefstra syndrome, 22q11.2 deletion syndrome, Prader-Willi syndrome, Klinefelter syndrome (47,XXY), etc.
- •4.Contraindication for MRI examination or rTMS, such as metal implantation in the body, epilepsy, cochlear implants, etc.
- •5.Severe risk of self-injury or suicide
- •6.Other conditions where the researchers find unsuitable for the treatment
研究组 & 干预措施
control group: sham iTBS
Patients assigned to control group would receive treatment of sham iTBS. The iTBS mode in sham iTBS is as the same as the active iTBS, but would be delivered with the sham coil, which provides the sensation of TBS without enough magnetic energy to reach the cortex.
干预措施: Sham stimulation (Device)
experimental group: active iTBS
Patients assigned to experimental group would receive treatment of active iTBS. 50 iTBS sessions (1,800 pulses per session, 50-minute intersession interval) were delivered 10 days at 90% resting motor threshold.
干预措施: Intermittent theta burst stimulation(iTBS) (Device)
结局指标
主要结局
Change in Positive and Negative Symptom Scale (PANSS) score
时间窗: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
The PANSS measures positive symptoms, negative symptoms and general psychopathology. It contains 30 items, each item is scored from 1 to 7, higher score indicates more severe psychopathology in the dimension. Here the investigators use the Chinese version of the PANSS to evaluate the severity of symptoms in schizophrenia in different participant and different treatment phase. The investigators mainly focus on change in the total score of the negative symptoms.
Change in Scale for Assessment of Negative Symptoms(SANS) score
时间窗: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
The SANS measures the severity of negative symptoms in schizophrenia. It contains 24 items, each item is scored from 0 to 5, higher score indicates more severe symptom. The SANS evaluates five dimensions of the negative symptoms, which are apathy, poverty of thought, abulia, social withdrawal and disorders of attention.
Change in Positive and Negative Symptom Scale (PANSS) score
时间窗: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
The PANSS measures positive symptoms, negative symptoms and general psychopathology. It contains 30 items, each item is scored from 1 to 7, higher score indicates more severe psychopathology in the dimension. Here the investigators use the Chinese version of the PANSS to evaluate the severity of symptoms in schizophrenia in different participant and different treatment phase. The investigators mainly focus on change in the total score of the negative symptoms.
Change in Scale for Assessment of Negative Symptoms(SANS) score
时间窗: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
The SANS measures the severity of negative symptoms in schizophrenia. It contains 24 items, each item is scored from 0 to 5, higher score indicates more severe symptom. The SANS evaluates five dimensions of the negative symptoms, which are apathy, poverty of thought, abulia, social withdrawal and disorders of attention.
次要结局
- The data of head resting-state functional magnetic resonance imaging(Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7))
- Change in Personal and Social Performance Scale (PSP) score(Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7))
- Change of TMS-EEG (Transcranial Magnetic Stimulation Electroencephal(Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7))
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) score(Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7))
- Change in Calgary Depression Scale for Schizophrenia (CDSS) score(Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7))
- Change in Personal and Social Performance Scale (PSP) score(Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7))
- Change of TMS-EEG (Transcranial Magnetic Stimulation Electroencephal(Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7))
- The data of head resting-state functional magnetic resonance imaging(Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7))
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) score(Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7))
- Change in MATRICS Consensus Cognitive Battery (MCCB) score(Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7))
- Change in Global Assessment Function (GAF) score(Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7))
- Change of electroencephalogram(Baseline, first day of treatment (day 1), the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7))
- Change in Calgary Depression Scale for Schizophrenia (CDSS) score(Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7))
研究者
Renrong Wu
professor
Central South University