Accelerated Transcranial Magnetic Stimulation in Treatment-Resistant Depressed Patients: Comparison Of The Effectiveness Of Bilateral Theta Bursts With Unilateral Theta Bursts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Depression severity
研究概览
简要总结
Depression is the leading cause of disability worldwide and around 800,000 suicides occur each year. According to the World Health Organization, major depressive disorder (MDD) is expected to be the leading cause of the global burden of disease by 2030. One third of MDD patients do not respond to first-line pharmacologic and psychotherapeutic antidepressant treatments. New antidepressant treatments that are safe, tolerable, fast-acting, durable and effective are needed. Transcranial magnetic stimulation (TMS) is a promising form of non-invasive brain stimulation with rapid antidepressant and suicide prevention effects in MDD. TMS applied to the left dorsolateral prefrontal cortex (DLPFC) is a non-invasive brain stimulation technique approved by the US Food and Drug Administration (FDA) for treatment-resistant depression. TMS involves passing an electric current through a magnetic coil placed on the surface of the scalp, producing a high-intensity magnetic field that travels through the scalp, skull and meninges, stimulating neuronal tissue. This in turn causes changes in functional connectivity. The mechanism of TMS on core depressive symptoms is hypothesized to be mediated in part through indirect inhibitory functional connectivity from the left DLPFC to the subgenual anterior cingulate cortex (sgACC).
详细描述
The aim of this study was to investigate whether recurrent TMS (rTMS) and theta burst stimulation (TBS) are superior to each other when applied unilaterally and bilaterally in treatment-resistant MDD. As stated in the reference articles, a similar study was conducted unilaterally at Stanford University and achieved 70% remission rates. Our goal is that bilateral administration will result in longer treatment compliance and duration of effect compared to unilateral administration. This study aims to monitor the change in neurocognitive functions of patients with moderate to severe depression diagnosed with major depression according to DSM 5 criteria, whose treatment is prescribed by their physician as transcranial magnetic stimulation (TMS) and whose current pharmacological treatment is continued concurrently with TMS treatment, at the controls to be performed before TMS treatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 14 weeks after the start of TMS treatment. For this purpose, structured neuropsychological tests with Turkish validity and reliability studies will be applied to the patients. In addition, the study aims to evaluate whether there will be a decrease in the severity of depression after TMS treatment and whether there is any change in depression severity and symptoms in the 1st week, 2nd week, 4th week, 6th week, 8th week, 10th week and 14th week controls through the scales measuring the severity of depression to be applied to the patients participating in the study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 65 years old
- •Patients diagnosed with Major Depressive Disorder according to DSM 5 and the severity of their illness
- •Scoring 7 points or more on the Maudsley staging method
- •Having depression unresponsive to 2 different antidepressants
- •No clinical mental retardation
- •Agree to participate in the study
- •Hamilton Depression Rating Scale-17 [HDRS] score of 20 or higher
- •Montgomery Asberg Depression Rating Scale [MADRS] score of 20 or above
- •Being right hand dominant
- •Having used the same antidepressant at the same dose for the last 4 weeks
排除标准
- •Diagnosed with a neurological or metabolic disease that affects cognitive functions (Systemic diseases such as diabetes mellitus, cardiovascular disease, cerebrovascular disease, chronic renal failure, Parkinson's disease, multiple sclerosis, polyneuropathy, inflammatory rheumatologic disease and malignancies)
- •Having a foreign body such as a pacemaker, intracranial implant that can magnetically interact
- •Hearing and visual impairments that prevent communication
- •Unstable or acute medical conditions
- •Pregnancy or breastfeeding
- •Having a primary psychiatric disorder other than major depressive disorder
- •Being diagnosed with severe MDD with psychotic features
研究组 & 干预措施
A group
iTBS with eight digit coils to the left dorsolateral prefrontal cortex and cTBS with a figure-of-eight coil to the right dorsolateral prefrontal cortex.
干预措施: Transcranial Magnetic Stimulation with figure-eight coil (Device)
B group
iTBS with eight digit coils to the left dorsolateral prefrontal cortex and sham Sham cTBS with a figure-of-eight coil to the right dorsolateral prefrontal cortex.
The sham cTBS treatment will be administered by placing the coil at a 45-degree angle to the application site.
干预措施: Transcranial Magnetic Stimulation with figure-eight coil (Device)
结局指标
主要结局
Depression severity
时间窗: pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks
The Montgomery-Asberg Depression Rating Scale. The minimum and maximum scores are 0-60. Higher scores mean a worse outcome.
次要结局
- Anxiety severity(pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks)
- Suicidal ideation score of The Hamilton Depression Rating Scale-17(pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks)
- Suicidal ideation score of The Montgomery-Asberg Depression Rating Scale(pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks)
- Insomnia Severity(pretreatment, 4 weeks, 10 weeks and 14 weeks)
- Cognitive Assessment(pretreatment, 4 weeks, 10 weeks and 14 weeks)
- Functionality Severity(pretreatment, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks)
- Insomnia Severity(pretreatment, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 14 weeks)
研究者
Omer Faruk Uygur
associate professor
Ataturk University