The Study of Effectiveness of Unilateral and Bilateral Repetitive Transcranial Magnetic Stimulation (rTMS) on Rumination and Anhedonia in Patients With Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- changes in default mode network
研究概览
简要总结
Rumination is significantly frequent in major depressive disorder. However, not a lot of studies have investigated the effects of repetitive transcranial magnetic stimulation on rumination and its electrophysiological correlates. This study recruited 61 participants who were randomly assigned to sham, bilateral, or unilateral stimulation groups to investigate the potential differences between these stimulation protocols and changes in the behavioral and electrophysiological outcomes after treatment.
详细描述
This study aims to compare the effect of unilateral and bilateral rTMS on the reduction of rumination and anhedonia and their associated neural networks. In a randomized double-blind trial, 65 patients with depressive disorder in Atieh Clinical Neuroscience Center are assigned to three groups. The first group receives bilateral rTMS for 20 sessions on right and left DLPFC; the second group receives unilateral rTMS for 20 sessions on LDLPFC; third group receives sham rTMS for 10 sessions. In this group, the stimulation parameters are similar to that in the actual rTMS group, except that the coil angel is 90° and perpendicular to the head. Rumination and anhedonia symptoms will be measured by the Ruminative Responses Scale (RRS) and Snaith-Hamilton Pleasure Scale (SHAPS) in the baseline and after the 20th session. In order to investigate the neural networks associated with rumination and anhedonia, EEG of patients will be recorded at the first session and at the end of the treatment.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients male and female with the range of 18-65 years of age
- •The diagnosis of Major depressive disorder according to DSM-V
- •Having BDI>18
- •Having stable symptoms as defined by not requiring a change in medication for at least 4 weeks
- •Completion of consent form
- •Being under supervision of a psychiatrist
排除标准
- •The history of rTMS treatment for any reason
- •Cardiac pacemaker
- •The risk of seizure with any reasons
- •Pregnancy
- •High risk of suicide
- •Intracranial implant and other ferromagnetic materials close to the head
研究组 & 干预措施
bilateral rTMS
sequential bilateral repetitive Transcranial Magnetic Stimulation (rTMS)
干预措施: Bilateral rTMS (Device)
Sham rTMS
Sham Transcranial Magnetic Stimulation (rTMS)
干预措施: Sham rTMS (Device)
Unilateral rTMS
Unilateral (High frequency) repetitive Transcranial Magnetic Stimulation (rTMS)
干预措施: Unilateral rTMS (High frequency) (Device)
结局指标
主要结局
changes in default mode network
时间窗: baseline before start of treatment and immediately after the last treatment session.
EEG
Rumination Symptoms
时间窗: baseline before start of treatment and immediately after the last treatment session.
The Ruminative Responses Scale (RRS) is a measure of depressive rumination which has two subscales: Both subscales are composed of five items. Brooding and Reflection. Higher score indicate a higher level of ruminative responses (range: 22-88).
Anhedonia Symptoms
时间窗: baseline before start of treatment and immediately after the last treatment session.
Snaith-Hamilton Pleasure Scale (SHAPS), a measure of anhedonia
次要结局
- Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale(baseline before start of treatment and immediately after the last treatment session.)
- Depressive symptoms measured by the 21-item Beck Depression Inventory-II(baseline before start of treatment and immediately after the last treatment session.)
研究者
reza kazemi
Researcher
University of Tehran