Shiozawa Pedro, Duailibi Michel Silvio, da Silva Mailu Enokibara, Cordeiro Quirino
The Clinical Neuromodulation Laboratory, Santa Casa Medical School, São Paulo, Brazil.
The Clinical Neuromodulation Laboratory, Santa Casa Medical School, São Paulo, Brazil.
Epilepsy Behav. 2014 Oct;39:6-9. doi: 10.1016/j.yebeh.2014.07.021. Epub 2014 Aug 23.
Major depressive disorder (MDD) is an incapacitating mental disorder associated with significant personal, social, and economic impairment. Patients with MDD present lower quality of life and higher prevalence of medical conditions, including epilepsy. Noninvasive brain stimulation (NIBS) is a technique that might aid in overcoming some of the current challenges related to pharmacotherapy. Trigeminal nerve stimulation is an incipient, simple, low-cost interventional strategy based on the application of an electric current over a branch of the trigeminal nerve with further propagation of the stimuli toward brain areas related to mood symptoms.
We performed an open-label proof-of-concept trial using TNS for MDD. To the best of our knowledge, we present a TNS interventional protocol that has not been evaluated for MDD hitherto.
A total of 11 patients were studied, with a mean age of 50.36 years (sd: 11.8 from 30 to 60). Only one patient was male. Regarding the main outcome, there was a reduction of depressive symptoms with a mean score of 5.72 (sd: 2.24) (p<0.001) on the HDRS-17. Considering a categorical analysis, all patients presented clinical response defined as a reduction of scores of at least 50%. Only one patient did not reach a remission score (defined as an HDRS score lower than 8).
In the current neuromodulation scenario, clinical results have been working as truly hypothesis-driven forces, i.e., empirical observation and data analysis from different studies have been highlighting possible mechanisms related to the neurobiological functioning of neuromodulation strategies. The present results, however significant, need to be taken as hypothesis-driven given the study design. Data generalization is jeopardized due to the present study lacking a control group. Our results, therefore, may be overestimated due to intrinsic characteristics such as the placebo effect and Hawthorne effect.
We present a proof-of-concept trial evaluating a new TNS protocol for depression. Data analysis underscores a significant participation of TNS in ameliorating depressive symptoms of patients with moderate or severe depressive episode. Further controlled studies will contribute to establish the clinical relevance of this new strategy for MDD.
重度抑郁症（MDD）是一种使人丧失能力的精神障碍，会导致严重的个人、社会和经济损害。MDD患者的生活质量较低，且包括癫痫在内的躯体疾病患病率较高。无创脑刺激（NIBS）是一种可能有助于克服当前药物治疗相关挑战的技术。三叉神经刺激是一种基于在三叉神经分支上施加电流，并使刺激进一步传播至与情绪症状相关脑区的初期、简单且低成本的干预策略。
我们开展了一项使用三叉神经刺激治疗MDD的开放标签概念验证试验。据我们所知，我们提出了一种迄今尚未针对MDD进行评估的三叉神经刺激干预方案。
共研究了11名患者，平均年龄为50.36岁（标准差：11.8，年龄范围30至60岁）。仅1名男性患者。关于主要结局，汉密尔顿抑郁量表17项版（HDRS-17）评分显示抑郁症状减轻，平均得分5.72（标准差：2.24）（p<0.001）。进行分类分析时，所有患者均呈现临床反应，定义为得分至少降低50%。仅1名患者未达到缓解评分（定义为HDRS评分低于8分）。
在当前的神经调节背景下，临床结果一直是真正的假设驱动力量，即来自不同研究的实证观察和数据分析一直在突出与神经调节策略神经生物学功能相关的可能机制。然而，鉴于本研究设计，目前的结果虽具有显著性，但仍需视为假设驱动。由于本研究缺乏对照组，数据的普遍性受到影响。因此，我们的结果可能因安慰剂效应和霍桑效应等内在特征而被高估。
我们展示了一项评估用于抑郁症的新三叉神经刺激方案的概念验证试验。数据分析强调了三叉神经刺激在改善中度或重度抑郁发作患者抑郁症状方面的重要作用。进一步的对照研究将有助于确立这一针对MDD的新策略的临床相关性。
