Department of Neurology, SGPGIMS, Rae bareli road, Lucknow, UP, 226014, India.
Department of Biostatistics and Health Informatics, SGPGIMS, Lucknow, India.
J Headache Pain. 2024 Sep 18;25(1):155. doi: 10.1186/s10194-024-01866-4.
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: rTMS was well tolerated and effective in reducing pain severity, headache days and headache related disability, depressive and anxiety symptoms. TRIAL REGISTRATION: CTRI/2023/05/053247.
背景：新的每日持续性头痛（NDPH）是一种从发病开始持续不断、无法缓解的头痛，传统药物对此的疗效并不理想。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途的非侵入性治疗方法，而神经调节在 NDPH 中的研究还不够充分。本研究的目的是评估 rTMS 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的疗效。
方法：这是一项于 2022 年 10 月至 2023 年 9 月期间进行的开放标签前瞻性单臂干预性试点研究。所有符合条件的参与者均接受了为期三天的左前额皮质 10 Hz rTMS（600 个脉冲，10 个疗程）治疗。在四周内每周记录一次治疗后的头痛严重程度，并与治疗前的参数进行比较。主要结局定义为视觉模拟量表（VAS）评分的头痛严重程度至少降低 50%，从基线开始头痛天数减少，次要结局为 4 周时 HIT-6 评分至少降低 6 分。
结果：共有 50 名 NDPH 患者（平均[标准差]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%）报告疼痛严重程度至少改善了 50%（p 值<0.001），与基线时 28 天的 28 天头痛天数相比，平均减少了 10.84（4.88）个头痛日（p 值<0.001）。38 名患者（76%）报告 4 周时 HIT 评分至少降低了 6 分。慢性偏头痛的 NDPH 患者观察到上述参数的最大改善。两名患者报告对 rTMS 的声音不耐受。PHQ-9 和 GAD-7 的中位数（IQR）评分分别从 11.5（3.75，20）降至 7（2，15）（p 值<0.001）和 10（3，14）降至 5.5（0，9）（p 值<0.001）。
结论：rTMS 耐受性良好，能有效降低疼痛严重程度、头痛天数和头痛相关残疾、抑郁和焦虑症状。
试验注册：CTRI/2023/05/053247。
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