Neurolief Depression Therapy

神经性抑郁症治疗

This study marks a historic milestone as the first ever Randomized Controlled Trial (RCT) to demonstrate success in a non-pharmacological home therapy for Treatment Resistant Major Depression.TAMPA, Fla., June 25, 2024 /PRNewswire/ -- Neurolief, a leading developer of innovative brain neuromodulation technologies, announces the groundbreaking topline results from its pivotal clinical trial evaluating the efficacy and safety of its revolutionary brain neuromodulation therapy for patients suffering from Treatment Resistant Depression (TRD).

这项研究标志着一个历史性的里程碑，是有史以来第一个证明非药物家庭治疗难治性抑郁症成功的随机对照试验（RCT）。佛罗里达州坦帕，2024年6月25日/PRNewswire/-Neurolief，创新脑神经调节技术的领先开发人员，宣布了其关键临床试验的开创性结果，该试验评估了其革命性脑神经调节疗法对患有难治性抑郁症（TRD）的患者的疗效和安全性。

Neurolief's non-invasive medical technology, designed for clinic and at-home treatment, marks a significant advancement in the management of TRD, offering new hope for millions of patients worldwide who have previously not responded, or not sufficiently responded, to pharmaceutical treatments..

Neurolief的非侵入性医疗技术专为临床和家庭治疗而设计，标志着TRD管理的重大进步，为全球数百万以前对药物治疗没有反应或反应不足的患者提供了新的希望。。

The double-blind, randomized, placebo-controlled, multi-center clinical trial enrolled 124 participants across leading medical centers in the United States and Israel. The study's primary endpoint was a reduction in depression severity as measured by the Hamilton Depression Rating Scale (HDRS17). Key findings from the trial include:.

这项双盲、随机、安慰剂对照、多中心临床试验在美国和以色列的主要医疗中心招募了124名参与者。该研究的主要终点是汉密尔顿抑郁量表（HDRS17）测量的抑郁严重程度降低。试验的主要发现包括：。

Significant Reduction in Depression Symptoms: Patients receiving Neurolief's brain neuromodulation therapy showed a statistically significant reduction in HDRS17 scores compared to the control group.

抑郁症状显着减少：与对照组相比，接受Neurolief脑神经调节治疗的患者HDRS17评分在统计学上显着降低。

High Remission Rate: A substantial proportion of patients achieved full remission from depression symptoms (HDRS17 score ≤7), demonstrating the therapy's profound impact.

高缓解率：相当一部分患者的抑郁症状完全缓解（HDRS17评分≤7），证明了该疗法的深远影响。

Favorable Safety Profile: The therapy was well-tolerated, with no serious adverse events related to the treatment, underscoring its safety.

良好的安全性：该疗法耐受性良好，没有与治疗相关的严重不良事件，强调了其安全性。

High Adherence to the Treatment Protocol: Approximately 95% of patients fully complied with the daily treatment regimen throughout the 16-week treatment period.

高度遵守治疗方案：在整个16周的治疗期间，大约95%的患者完全遵守每日治疗方案。

Dr. Linda Carpenter, Professor of Psychiatry and Human Behavior at the Warren Alpert Medical School at Brown University and the principal investigator of the trial, stated,'So many of my patients do not get relief from their antidepressant medications and struggle to find effective treatment options for their depression.

布朗大学沃伦·阿尔伯特医学院（WarrenAlpert Medical School）精神病学和人类行为学教授、该试验的首席研究员琳达·卡彭特（LindaCarpenter）博士表示，“我的许多患者都没有从抗抑郁药物中得到缓解，因此很难找到有效的抑郁症治疗方案。

I want them to get better without adding more medications to their regimen, but many of them simply cannot manage daily trips to the clinic for other offered treatments. I am thrilled that I will soon be able to prescribe Neurolief's therapy for my patients to treat at home!The results of this clinical trial not only show this technology is safe and effective for relieving depression symptoms, but also that patients can self-administer their therapy in a time and place when it is convenient for them and get better! This will have a tremendous impact on the approach for treating major depressive disorder.'Dr.

我希望他们在不增加更多药物的情况下病情好转，但他们中的许多人根本无法每天前往诊所接受其他提供的治疗。我很兴奋，我很快就能为我的病人开Neurolief的治疗处方，让他们在家里治疗！这项临床试验的结果不仅表明该技术对于缓解抑郁症状是安全有效的，而且患者可以在方便的时间和地点自行治疗并得到改善！这将对治疗重度抑郁症的方法产生巨大影响。”博士。

Mark George, Distinguished Professor of Psychiatry, Radiology, and Neuroscience and Director of the Medical University of South Carolina (MUSC) Brain Stimulation Division, who was an investigator in the study, commented, 'This is such an important study as it shows that patients with depression can effectively treat their depression using Neurolief's brain stimulation technology at home, under a doctor's supervision.

该研究的研究员、精神病学、放射学和神经科学杰出教授、南卡罗来纳医科大学（MUSC）脑刺激部主任马克·乔治（Mark George）评论道：“这是一项非常重要的研究，因为它表明抑郁症患者可以在医生的监督下，在家中使用Neurolief的脑刺激技术有效治疗抑郁症。

This will greatly expand access to therapy for people who live far away from medical centers, who are working, have children or cannot travel long distances to the clinic. This non-medication medical technology has no drug-drug interactions or other side effects common with medications. This is a great day for patients with depression!'Scott Drees, CEO of Neurolief, added, 'We are dedicated to addressing the unmet needs of patients and .

这将大大扩大居住在远离医疗中心、正在工作、有孩子或无法长途前往诊所的人获得治疗的机会。这种非药物治疗的医疗技术没有药物相互作用或药物常见的其他副作用。对于抑郁症患者来说，这是一个伟大的日子Neurolief首席执行官斯科特·德雷斯（ScottDrees）补充道，“我们致力于解决患者和患者未满足的需求。