Fineberg Naomi A, Cinosi Eduardo, Smith Megan V A, Busby Amanda D, Wellsted David, Huneke Nathan T M, Garg Kabir, Aslan Ibrahim H, Enara Arun, Garner Matthew, Gordon Robert, Hall Natalie, Meron Daniel, Robbins Trevor W, Wyatt Solange, Pellegrini Luca, Baldwin David S
Hertfordshire Partnership NHS University Foundation Trust, Highly Specialised OCD and BDD Service, Rosanne House, Parkway, Welwyn Garden City, Hertfordshire, UK; School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Hertfordshire, UK; Clinical Medical School, University of Cambridge, UK.
Hertfordshire Partnership NHS University Foundation Trust, Highly Specialised OCD and BDD Service, Rosanne House, Parkway, Welwyn Garden City, Hertfordshire, UK; School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Hertfordshire, UK.
Compr Psychiatry. 2023 Apr;122:152371. doi: 10.1016/j.comppsych.2023.152371. Epub 2023 Jan 26.
Transcranial direct current stimulation (tDCS) is a non-invasive form of neurostimulation with potential for development as a self-administered intervention. It has shown promise as a safe and effective treatment for obsessive compulsive disorder (OCD) in a small number of studies. The two most favourable stimulation targets appear to be the left orbitofrontal cortex (L-OFC) and the supplementary motor area (SMA). We report the first study to test these targets head-to-head within a randomised sham-controlled trial. Our aim was to inform the design of future clinical research studies, by focussing on the acceptability and safety of the intervention, feasibility of recruitment, adherence to and tolerability of tDCS, and the size of any treatment-effect.
FEATSOCS was a randomised, double-blind, sham-controlled, cross-over, multicentre study. Twenty adults with DSM-5-defined OCD were randomised to treatment, comprising three courses of clinic-based tDCS (SMA, L-OFC, Sham), randomly allocated and delivered in counterbalanced order. Each course comprised four 20-min 2 mA stimulations, delivered over two consecutive days, separated by a 'washout' period of at least four weeks. Assessments were carried out by raters who were blind to stimulation-type. Clinical outcomes were assessed before, during, and up to four weeks after stimulation. Patient representatives with lived experience of OCD were actively involved at all stages.
Clinicians showed willingness to recruit participants and recruitment to target was achieved. Adherence to treatment and study interventions was generally good, with only two dropouts. There were no serious adverse events, and adverse effects which did occur were transient and mostly mild in intensity. Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores were numerically improved from baseline to 24 h after the final stimulation across all intervention groups but tended to worsen thereafter. The greatest effect size was seen in the L-OFC arm, (Cohen's d = -0.5 [95% CI -1.2 to 0.2] versus Sham), suggesting this stimulation site should be pursued in further studies. Additional significant sham referenced improvements in secondary outcomes occurred in the L-OFC arm, and to a lesser extent with SMA stimulation.
tDCS was acceptable, practicable to apply, well-tolerated and appears a promising potential treatment for OCD. The L-OFC represents the most promising target based on clinical changes, though the effects on OCD symptoms were not statistically significant compared to sham. SMA stimulation showed lesser signs of promise. Further investigation of tDCS in OCD is warranted, to determine the optimal stimulation protocol (current, frequency, duration), longer-term effectiveness and brain-based mechanisms of effect. If efficacy is substantiated, consideration of home-based approaches represents a rational next step.
ISRCTN17937049. https://doi.org/10.1186/ISRCTN17937049.
经颅直流电刺激（tDCS）是一种非侵入性神经刺激形式，有发展成为自我管理干预措施的潜力。在少数研究中，它已显示出作为强迫症（OCD）安全有效治疗方法的前景。两个最有利的刺激靶点似乎是左侧眶额皮质（L-OFC）和辅助运动区（SMA）。我们报告了第一项在随机假对照试验中对这些靶点进行直接对比测试的研究。我们的目的是通过关注干预措施的可接受性和安全性、招募的可行性、tDCS的依从性和耐受性以及任何治疗效果的大小，为未来的临床研究设计提供信息。
FEATSOCS是一项随机、双盲、假对照、交叉、多中心研究。20名符合DSM-5定义的强迫症成年患者被随机分配接受治疗，包括三个疗程的基于诊所的tDCS（SMA、L-OFC、假刺激），随机分配并以平衡顺序进行。每个疗程包括四次20分钟、2毫安的刺激，连续两天进行，中间间隔至少四周的“洗脱期”。评估由对刺激类型不知情的评估者进行。在刺激前、刺激期间以及刺激后长达四周的时间内评估临床结果。有强迫症生活经历的患者代表积极参与了所有阶段。
临床医生愿意招募参与者并实现了目标招募人数。对治疗和研究干预措施的依从性总体良好，只有两名患者退出。没有严重不良事件，确实发生的不良反应是短暂的，强度大多为轻度。所有干预组从基线到最后一次刺激后24小时，耶鲁-布朗强迫症量表（Y-BOCS）评分在数值上有所改善，但此后趋于恶化。在L-OFC组观察到最大的效应量（Cohen's d = -0.5 [95% CI -1.2至0.2] 对比假刺激），表明该刺激部位应在进一步研究中探索。L-OFC组在次要结果方面还出现了额外的显著假对照改善，SMA刺激在较小程度上也有改善。
tDCS是可接受的，应用可行，耐受性良好，似乎是一种有前景的强迫症潜在治疗方法。基于临床变化，L-OFC是最有前景的靶点，尽管与假刺激相比，对强迫症症状的影响在统计学上不显著。SMA刺激显示出的前景迹象较少。有必要对tDCS在强迫症中的应用进行进一步研究，以确定最佳刺激方案（电流、频率、持续时间）、长期有效性以及基于大脑的作用机制。如果疗效得到证实，考虑采用家庭治疗方法是合理的下一步。
ISRCTN17937049。https://doi.org/10.1186/ISRCTN17937049。
