Transcranial Direct Current Stimulation (tDCS) in Treatment-resistant Depression - Effect on Clinical and Neurophysiological Parameters
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Hamilton Psychiatric Rating Scale for Depression (HRSD-24)
研究概览
简要总结
tDCS applies a small amount of direct electric current (DC) to the brain by means of two electrodes: the one is an active electrode, localized on the effective site, and the other is a reference electrode, localized on some "silent" part of the body. Anodal transcranial direct current stimulation (tDCS) of the left dorsolateral prefrontal cortex (DLPFC) has been associated with working memory enhancement and improvement of mood. This study will investigate the possible antidepressant effects of tDCS in patients with therapy resistant major depressive episodes.
详细描述
Transcranial direct current stimulation (tDCS) is a non-invasive method that shifts membrane potential towards hypo- or hyperpolarization and therefore leads to functional changes in a discrete area of the cerebral cortex.
Neurophysiological studies have shown that slow changes in cortical scalp potential reflect overall activity of cortical neuronal networks. These scalp potentials reflect shifts in membrane potentials of the cortical neurons. Over the past 7 years tDCS has evolved as an important tool to non-invasively manipulate specific neural circuits of the human brain.
The purpose of this study is an investigation of tDCS applied to 20 therapy-resistance major depressive patients. Our hypothesis is that tDCS may exert an antidepressant effect and/or enhances the medication effect. tDCS will be examined in the framework of a placebo-controlled clinical pilot-study investigating effectiveness, safety and influence on EEG parameters. Patients will receive anodal DC stimulation or sham stimulation (extra designed placebo-stimulator) in a double-blind design over 10 days for each condition. Outcomes will be evaluated using several clinical, psychiatric and neuropsychological rating scales.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •At least moderate major depressive episode (DSM IV criteria).
- •Stable total pre-treatment Hamilton Rating Scale for Depression score ≥18
- •Therapy-resistance during current depressive episode (according to ATHF).
- •The patient must be in the condition to understand the patient-information, as well as the necessary examinations. He/she must be able to give a written consent.
- •Stable antidepressant medication, that is retained during the study- duration, from at least three weeks before the begin of the study.
排除标准
- •Existence of a care/legal incapacity
- •Existing pregnancy
- •Severe psychiatric illness (with exception of affective disorder)
- •Acute suicidality
- •Drug-, medication- or alcohol dependence
- •Dementia according to DSM IV / ICD 10-criterions
- •Severe TBI in the anamnesis
- •Indications of structural damage of the basal ganglia or the brain stem
- •Severe neurological disorders (e.g. M. Parkinson, epilepsy, discus-prolapse, dementia, systemic neurological illnesses, normal pressure hydrocephalus, cerebrovascular diseases, elevated intracranial pressure, in the last 6 months, polyneuropathies).
- •Severe other medical conditions, like manifest arterial hypertonia, severe heart disease, pacemakers, respiratory failure, malignant illnesses all type, also in the history, active infectious diseases, skeletal disorders (like M. Paget, osteoporosis with spontaneous fractures, fresh fractures)
- •Other circumstances, that speaks against a participation of the patient pinion of MD at this study.
结局指标
主要结局
Hamilton Psychiatric Rating Scale for Depression (HRSD-24)
时间窗: 6
次要结局
- Beck depression Inventory (BDI) Clinical Global Impression (CGI) Mini-Mental-Status-Test (MMST) Verbal Learning and Memory Test (VLMT) Regensburger Word Fluency Test (RWT)(4)