Harika-Germaneau Ghina, Heit Damien, Drapier Dominique, Sauvaget Anne, Bation Remy, Chatard Armand, Doolub Damien, Wassouf Issa, Langbour Nicolas, Jaafari Nematollah
Unité de Recherché Clinique Intersectorielle en Psychiatrie à vocation régionale du Centre Hospitalier Henri Laborit, Poitiers, France.
Université de Poitiers, Poitiers, France.
Front Psychiatry. 2024 May 17;15:1338594. doi: 10.3389/fpsyt.2024.1338594. eCollection 2024.
The present study evaluated the therapeutic efficacy and tolerability of 10 transcranial direct current stimulation (tDCS) sessions in treatment-resistance obsessive-compulsive disorder (OCD) patients using a multisite double-blind sham-controlled design.
Eighty treatment-resistance outpatients suffering from obsessive-compulsive disorder were randomized to receive either active or sham transcranial direct current stimulation. The cathode was positioned over the supplementary motor area and the anode over the right supraorbital area. Patients were evaluated at baseline, end of treatment (day 14), one-month follow-up (day 45), and three-month follow-up (day 105) on the Yale-Brown Obsessive Compulsive Scale.
Although a significant interaction between time and treatment was observed, the primary endpoint-measuring the change in Yale-Brown obsessive compulsive scale scores after two weeks-was not achieved. Conversely, the secondary endpoint, which concerned the change in Yale-Brown obsessive compulsive scale scores after three months, was successfully met. It is important to note, however, that there were no significant differences in the percentage of responders and remitters at any of the post-treatment assessments. This suggests that the treatment may not have had a clinically relevant impact. Patients well received the transcranial direct current stimulation treatment, indicating its good tolerability.
This is the largest controlled trial using transcranial direct current stimulation in treatment-resistance obsessive-compulsive disorder patients. Our results indicate the importance of studying the placebo effect in transcranial direct current stimulation and the necessity to consider a long follow-up time to best evaluate the effects of the intervention.
ClinicalTrials.gov, identifier NCT03304600.
本研究采用多部位双盲假刺激对照设计，评估了10次经颅直流电刺激（tDCS）治疗难治性强迫症（OCD）患者的疗效和耐受性。
80名患有强迫症的难治性门诊患者被随机分配接受主动或假经颅直流电刺激。阴极置于辅助运动区上方，阳极置于右侧眶上区上方。在基线、治疗结束时（第14天）、1个月随访（第45天）和3个月随访（第105天）时，使用耶鲁-布朗强迫症量表对患者进行评估。
虽然观察到时间和治疗之间存在显著交互作用，但未达到主要终点——测量两周后耶鲁-布朗强迫症量表评分的变化。相反，涉及三个月后耶鲁-布朗强迫症量表评分变化的次要终点成功达成。然而，需要注意的是，在任何治疗后评估中，反应者和缓解者的百分比均无显著差异。这表明该治疗可能没有产生临床相关影响。患者对经颅直流电刺激治疗接受良好，表明其耐受性良好。
这是在难治性强迫症患者中使用经颅直流电刺激的最大规模对照试验。我们的结果表明了研究经颅直流电刺激中安慰剂效应的重要性，以及考虑较长随访时间以最佳评估干预效果的必要性。
ClinicalTrials.gov，标识符NCT03304600。
