Background

Noninvasive neurostimulation with transcranial Pulsed Electromagnetic Fields (tPEMF) may be a promising method for treatment resistant depression (TRD). Studies shown substantial improvement of depressive symptoms in patients with TRD, but there is no information on long-term antidepressant effects. The aim of this study was to investigate the short- and long-term efficacy of tPEMF in participants with TRD.

Methods

Eligible participants with TRD in this sham-controlled double-blind multicenter trial were randomly assigned to five weeks either daily active or sham tPEMF. Severity of depression and anxiety was assessed pre- and directly post-treatment and five and fifteen weeks post-treatment. Primary outcome was change on the 17-item Hamilton depression rating scale directly post-treatment. Secondary outcome was change on the Hamilton-17 during follow-up and change on the Inventory of Depressive Symptomatology Self-Report and the Beck Anxiety Index.

Results

Of the 55 included participants, 50 completed the treatment protocol. Depressive symptoms improved over time in both groups. The improvement continued until the last follow-up measure. There was no difference in outcome between the active and the sham group on change in depression post-treatment or on any secondary measure.

Conclusion

Treatment with this type of active tPEMF was not superior to sham in patients with TRD. This is in contrast to a previous study using a similar design and power calculation, but a higher magnetic field strength, that reported improvement of depression after treatment with tPEMF compared to sham. An important limitation of our study was the fact that no different dosing regimens were tried.

中文翻译：

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低强度经颅脉冲电磁场​​治疗抵抗性抑郁症无抗抑郁作用

背景

使用经颅脉冲电磁场​​ (tPEMF) 进行无创神经刺激可能是治疗抵抗性抑郁症 (TRD) 的一种很有前景的方法。研究表明，TRD 患者的抑郁症状得到显着改善，但没有关于长期抗抑郁作用的信息。本研究的目的是调查 tPEMF 对 TRD 参与者的短期和长期疗效。

方法

在这项假对照双盲多中心试验中，符合条件的 TRD 参与者被随机分配到 5 周，每日活动或假 tPEMF。抑郁和焦虑的严重程度在治疗前和治疗后以及治疗后 5 周和 15 周进行评估。主要结果是直接治疗后 17 项汉密尔顿抑郁量表的变化。次要结果是随访期间 Hamilton-17 的变化以及抑郁症状自我报告清单和贝克焦虑指数的变化。

结果

在 55 名参与者中，50 人完成了治疗方案。随着时间的推移，两组的抑郁症状都有所改善。这种改善一直持续到最后一次后续措施。在治疗后抑郁症的变化或任何次要措施方面，活动组和假手术组之间的结果没有差异。

结论

在 TRD 患者中，用这种类型的活性 tPEMF 治疗并不优于假手术。这与之前使用类似设计和功率计算但磁场强度更高的研究形成对比，该研究报告与假手术相比，tPEMF 治疗后抑郁症有所改善。我们研究的一个重要限制是没有尝试不同的给药方案。