Abstract：
BACKGROUND: About 30% of patients diagnosed with major depressive disorder fail with the mainstream pharmacological treatment. Patients who do not achieve clinical remission of symptoms, even with two different antidepressants, are classified with treatment-resistant depression (TDR). This condition imposes an additional burden with increased Disability Adjusted Life Years. Therefore, complementary treatments, such as neuromodulation, are necessary. The transcranial focused ultrasound (tFUS) has emerged in the past few years as a reliable method for non-invasive neuromodulation in humans and may help treat TRD. This study aims to propose a research protocol for a non-inferiority randomized clinical trial of TDR with tFUS.
METHODS: Patients with documented TRD will be screened upon entering the TRD outpatient clinic at UFMG (Brazil). One hundred patients without a clinical history of other psychiatric illness, anatomical abnormalities on magnetic resonance imaging (MRI), or treatment with electroconvulsive therapy will be invited to participate. Patients will be randomized (1:1) into two groups: 1) treatment with a previously established protocol of transcranial magnetic stimulation; and 2) treatment with a similar protocol using the stimulation. Besides regular consultations in the outpatient clinic, both groups will attend 7 protocolled spaced days of brain stimulation targeted at the left dorsolateral prefrontal cortex. They will also be submitted to 4 sessions of image studies (2 MRIs, 2 positron-emission tomography), 3 of neuropsychological assessments (at baseline, 1 week and 2 months after treatment), the Montgomery-Åsberg Depression Rating Scale to analyze the severity of depressive symptoms.
CONCLUSIONS: This clinical trial intends to verify the safety and clinical efficacy of tFUS stimulation of the dorsolateral prefrontal cortex of patients with TRD, compared with a previously established neuromodulation method.
METHODS: Patients with documented TRD will be screened upon entering the TRD outpatient clinic at UFMG (Brazil). One hundred patients without a clinical history of other psychiatric illness, anatomical abnormalities on magnetic resonance imaging (MRI), or treatment with electroconvulsive therapy will be invited to participate. Patients will be randomized (1:1) into two groups: 1) treatment with a previously established protocol of transcranial magnetic stimulation; and 2) treatment with a similar protocol using the stimulation. Besides regular consultations in the outpatient clinic, both groups will attend 7 protocolled spaced days of brain stimulation targeted at the left dorsolateral prefrontal cortex. They will also be submitted to 4 sessions of image studies (2 MRIs, 2 positron-emission tomography), 3 of neuropsychological assessments (at baseline, 1 week and 2 months after treatment), the Montgomery-Åsberg Depression Rating Scale to analyze the severity of depressive symptoms.
CONCLUSIONS: This clinical trial intends to verify the safety and clinical efficacy of tFUS stimulation of the dorsolateral prefrontal cortex of patients with TRD, compared with a previously established neuromodulation method.
摘要：
背景：约30%被诊断为重度抑郁症的患者在主流药物治疗中失败。没有达到临床症状缓解的患者，即使有两种不同的抗抑郁药，被归类为难治性抑郁症(TDR)。这种情况增加了残疾调整寿命年的额外负担。因此,补充治疗,比如神经调节，是必要的。在过去的几年中，经颅聚焦超声（tFUS）已成为人类非侵入性神经调节的可靠方法，并可能有助于治疗TRD。本研究旨在为使用tFUS的TDR的非劣效性随机临床试验提出研究方案。
方法：有记录的TRD患者将在进入UFMG（巴西）的TRD门诊时进行筛查。一百名没有其他精神病临床病史的患者，磁共振成像（MRI）的解剖异常，或电惊厥治疗将被邀请参加。患者将被随机(1:1)分为两组:1)用先前建立的经颅磁刺激方案治疗;和2)用类似方案使用刺激治疗。除了在门诊定期咨询外，两组将参加7天间隔的针对左背外侧前额叶皮层的脑刺激。他们还将提交4次图像研究(2MRI，2正电子发射断层扫描)，3神经心理学评估(在基线时，治疗后1周和2个月），蒙哥马利-奥斯贝格抑郁量表分析抑郁症状的严重程度。
结论：本临床试验旨在验证tFUS刺激TRD患者背外侧前额叶皮质的安全性和临床疗效。与以前建立的神经调节方法相比。
方法：有记录的TRD患者将在进入UFMG（巴西）的TRD门诊时进行筛查。一百名没有其他精神病临床病史的患者，磁共振成像（MRI）的解剖异常，或电惊厥治疗将被邀请参加。患者将被随机(1:1)分为两组:1)用先前建立的经颅磁刺激方案治疗;和2)用类似方案使用刺激治疗。除了在门诊定期咨询外，两组将参加7天间隔的针对左背外侧前额叶皮层的脑刺激。他们还将提交4次图像研究(2MRI，2正电子发射断层扫描)，3神经心理学评估(在基线时，治疗后1周和2个月），蒙哥马利-奥斯贝格抑郁量表分析抑郁症状的严重程度。
结论：本临床试验旨在验证tFUS刺激TRD患者背外侧前额叶皮质的安全性和临床疗效。与以前建立的神经调节方法相比。
