Background

Transcranial direct current stimulation (tDCS) of prefrontal cortex regions has been reported to exert antidepressant effects, though large scale multicenter trials in major depressive disorder (MDD) supporting this notion are still lacking. Application of tDCS in multicenter settings, however, requires measurement, storage and evaluation of technical parameters of tDCS sessions not only for safety reasons but also for quality control. To address this issue, we conducted an interim analysis of supervised technical data across study centers in order to monitor technical quality of tDCS in an ongoing multicenter RCT in MDD (DepressionDC trial).

Methods

Technical data of 818 active tDCS sessions were recorded, stored in a data cloud, and analysed without violating study blinding. Impedance, voltage and current were monitored continuously with one data point recorded every second of stimulation.

Results

Variability of impedance was considerable (1,42 kΩ, to 8,23 kΩ), inter-individually and even more intra-individually, but did not significantly differ between the study centre in Munich and all other sites.

Conclusion

Measurement, centralized data storage via data cloud and remote supervision of technical parameters of tDCS are feasible and proposed for future RCTs on therapeutic tDCS in multiple settings.

中文翻译：

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重度抑郁症的经颅直流电刺激 (tDCS) – 来自 DepressionDC 试验的云监督技术数据的中期分析

背景

据报道，前额叶皮层区域的经颅直流电刺激 (tDCS) 具有抗抑郁作用，但仍缺乏支持这一观点的重度抑郁症 (MDD) 的大规模多中心试验。然而，tDCS 在多中心环境中的应用需要测量、存储和评估 tDCS 会话的技术参数，这不仅是出于安全原因，也是为了质量控制。为了解决这个问题，我们对跨研究中心的监督技术数据进行了中期分析，以便在正在进行的 MDD 多中心 RCT（DepressionDC试验）中监测 tDCS 的技术质量。

方法

818 个活动 tDCS 会话的技术数据被记录、存储在数据云中，并在不违反研究盲法的情况下进行分析。阻抗、电压和电流被连续监测，刺激的每一秒记录一个数据点。

结果

阻抗的可变性是相当大的（1.42 kΩ 到 8.23 kΩ），个体间甚至个体内部，但在慕尼​​黑的研究中心和所有其他站点之间没有显着差异。

结论

测量、通过数据云的集中数据存储和 tDCS 技术参数的远程监控是可行的，并建议用于未来在多种环境下治疗 tDCS 的 RCT。