Effect of Accelerated Repetitive Transcranial Magnetic Stimulation on Depression Symptoms in Patients With Subacute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Hamilton Depression Rating Scale (HAMD)
研究概览
简要总结
The FDA approved repetitive transcranial magnetic stimulation (rTMS) for patients with Major Depressive Disorder (MDD) in 2008. The conventional rTMS protocol that has been used effectively for major depression is 5 days per week for 4-6 weeks. The accelerated rTMS protocol involves conducting more than one session per day. In the treatment of post-stroke depression (PSD); although the effectiveness of conventional rTMS procedure has been shown in many studies, there is limited data on accelerated rTMS protocol in which the number of daily sessions is increased. In this study, we aimed to evaluate the efficacy of accelerated rTMS treatment on depression symptoms in patients diagnosed with PSD and whose depressive symptoms persist despite medical treatment, by comparing it with sham stimulation.
Question 1: Is accelerated rTMS an effective and reliable method in the treatment of post-stroke depression? Question 2: Is accelerated rTMS effective on quality of life, functional assessment and motor recovery in patients with post-stroke depression?
详细描述
Objective
Depression is a complication that negatively affects the quality of life and functional recovery of stroke patients and is associated with increased physical disability, cognitive and social impairment. In addition to being resistant to pharmacotherapy, the side-effect profile of the drugs used in the treatment and the increase in stroke recurrence, increase the need for new alternatives in the treatment of post-stroke depression (PSD). Repetitive transcranial magnetic stimulation (rTMS) is one of the treatment of interest in this field. In the treatment of PSD; although the effectiveness of conventional rTMS procedure has been shown in many studies, there is limited data on accelerated rTMS protocol in which the number of daily sessions is increased. In this study, we aimed to evaluate the efficacy of accelerated rTMS treatment on depression symptoms in patients diagnosed with PSD and whose depressive symptoms persist despite medical treatment, by comparing it with sham stimulation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic stroke in only one hemisphere is diagnosed by MRI,
- •Ischemic stroke within 1-6 months,
- •Diagnosis of major depression according to DSM-5 diagnostic criteria by a psychiatrist during post-stroke evaluations,
- •Hamilton Depression Rating Scale (HAMD) score of ≥8 as assessed by a clinical psychologist, despite receiving at least one antidepressant treatment,
- •Drug use should be stable for at least 2 weeks before accelerated rTMS treatment for depression treatment and no change in drug dose should be made for 6 weeks following treatment,
- •Mini mental test score ≥ 24
排除标准
- •Known history of epilepsy, dementia, cognitive impairment, neurodegenerative disease,
- •İntracranial metallic implant (cochlear implant, brain pacemaker, drug pump, etc.),
- •Lesions in the brain due to vascular, traumatic, tumoral or infectious reasons,
- •Recurrent strokes,
- •Alcoholism,
- •Pregnancy,
- •Cardiac pacemaker,
- •Patients diagnosed with psychiatric diseases other than depression
结局指标
主要结局
Hamilton Depression Rating Scale (HAMD)
时间窗: The depression severity of the patients was recorded by the clinical psychologist before the treatment, at the end of the treatment and 4 weeks after the end of the treatment.
The HAMD is the most widely used clinician-administered depression assessment scale. The original version contains 17 items pertaining to symptoms of depression experienced over the past week. By adding up the ratings, 0-53 points are obtained. 0-7 points indicate no depression, 8-15 points indicate mild depression, 16-28 indicates moderate depression, and 29 and above indicates severe depression. The version consisting of 17 items was used in our study, and the patients' response to treatment was evaluated based on these scale scores. At the end of the 2-week rTMS application period; A HAMD score of '7' or below is considered 'Remission', a 50% or more decrease in the HAMD score is considered 'There is a response to treatment', and a decrease of less than 50% in the HAMD score is considered 'No response to treatment'.
次要结局
- Brunnstrom Stages(Brunnstrom Stages was evaluated by the experimenter applying rTMS before treatment, at the end of treatment and 4 weeks after the end of treatment.)
- Functional Independence Measure (FIM)(Functional Independence Measure was evaluated by the experimenter applying rTMS before treatment, at the end of treatment and 4 weeks after the end of treatment.)
- Stroke Impact Scale 3.0 (SIS)(Stroke Impact Scale 3.0 was evaluated by the experimenter applying rTMS before the treatment, at the end of treatment and 4 weeks after the end of treatment.)
研究者
Hande Yakar
medical doctor
Ankara City Hospital Bilkent