重复经颅磁刺激治疗新的每日持续性头痛患者:单臂开放标签研究

M.M. Bharath, Vimal Kumar Paliwal, Swansu Batra, Prabhakar Mishra, Naina Mishra, Romil Saini
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引用次数: 0

摘要

新的每日持续性头痛(NDPH)是一种从发病开始就持续不断的头痛,传统药物治疗效果不佳。重复经颅磁刺激(rTMS)已成为治疗偏头痛等其他头痛疾病的一种很有前景的非侵入性疗法,但神经调节疗法在新每日持续性头痛中的应用尚未得到充分研究。本研究的目的是评估经颅磁刺激疗法在降低 NDPH 患者头痛频率和严重程度以及相关焦虑和抑郁症状方面的疗效。这是一项开放标签的前瞻性单臂介入试验研究,于 2022 年 10 月至 2023 年 9 月期间进行。所有符合条件的参与者都接受了10赫兹经颅磁刺激(600个脉冲,10列),连续3天作用于左前额叶皮层。连续四周每周记录经颅磁刺激后的头痛严重程度,四周结束时记录无头痛天数/功能障碍、PHQ-9和GAD-7评分,并与经颅磁刺激前的参数进行比较。主要结果的定义是视觉模拟量表(VAS)评分中头痛严重程度降低≥50%,头痛天数比基线减少,次要结果是4周时HIT-6评分降低≥6分。50 名 NDPH 患者(平均 [SD] 年龄为 35.06 [13.91] 岁;31 名女性 [62%])参与了这项研究。35名患者(70%)的疼痛严重程度改善了≥50%(P值<0.001),平均每28天头痛天数比基线的28天头痛天数减少了10.84(4.88)天(P值<0.001)。38名患者(76%)在4周时HIT评分降低了≥6分。在慢性偏头痛的 NDPH 患者中,上述参数的改善幅度最大。两名患者报告对经颅磁刺激的声音不耐受。经颅磁刺激疗法的中位数(IQR)PHQ-9和GAD-7评分分别从11.5(3.75,20)分降至7(2,15)分(p值< 0.001)和10(3,14)分降至5.5(0,9)分(p值< 0.001)。CTRI/2023/05/053247.
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Repetitive transcranial magnetic stimulation in new daily persistent headache patients: a single arm open label study
New daily persistent headache (NDPH) is a continuous, unremitting headache from onset that yields suboptimal results with traditional medicines. Repetitive transcranial magnetic stimulation (rTMS) has emerged as a promising non-invasive treatment for other headache disorders, such as migraine, and neuromodulation has not been well-studied in NDPH. The objective of the study was to evaluate the efficacy of rTMS in reducing the frequency and severity of headaches, and associated anxiety and depressive symptoms in NDPH patients. This was an open label prospective, single arm, interventional pilot study conducted between October 2022 and September 2023. All eligible participants received 10 Hz rTMS (600 pulses, 10 trains), delivered to the left prefrontal cortex for three consecutive days. The post-rTMS headache severity was recorded weekly for four weeks and headache free days/functional disability, PHQ-9, and GAD-7 scores at the end of four weeks and compared with pre-rTMS parameters. The primary outcome was defined by ≥ 50% reduction in headache severity on Visual Analogue Scale (VAS) score, decrease in headache days from the baseline and secondary outcome was ≥ 6 point reduction in HIT-6 score at 4 weeks. Fifty NDPH patients (mean [SD] age, 35.06 [13.91] years; 31 females [62%]) participated in this study. Thirty-five patients (70%) reported ≥ 50% improvement in pain severity (p-value < 0.001), with a mean reduction of 10.84 (4.88) headache days per 28 days from a baseline of 28 headache days (p-value < 0.001). Thirty-eight patients (76%) reported a ≥ 6 point’s reduction in HIT score at 4 weeks. Maximum improvement in the above parameters was observed in NDPH patients with chronic migraine. Two patients reported intolerance to the sound of the rTMS. The median (IQR) PHQ-9 and GAD-7 scores reduced from 11.5(3.75,20) to 7(2,15) (p-value < 0.001) and 10(3,14) to 5.5(0,9) (p-value < 0.001) respectively. rTMS was well tolerated and effective in reducing pain severity, headache days and headache related disability, depressive and anxiety symptoms. CTRI/2023/05/053247.
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