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EFFECT OF ANODAL TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS) OF PRIMARY MOTOR CORTEX ON HEADACHE FREQUENCY IN PATIENTS WITH CHRONIC MIGRAINE

2026年7月29日 更新者：Dr Ashish Kumar Duggal、Dr. Ram Manohar Lohia Hospital

Migraine is a common, heterogeneous neurological disorder affecting approximately 10-15% of the global population and is the third most prevalent disease worldwide. A wide range of pharmacological agents is available for migraine prophylaxis, with treatment selection generally guided by the patient's clinical profile, associated comorbidities, and individual tolerability. However, the effectiveness of preventive medications is often limited by adverse effects, leading to poor treatment adherence and discontinuation. Consequently, non-pharmacological interventions, particularly neuromodulation techniques, have gained increasing attention as potential therapeutic options for chronic migraine.

Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique that has demonstrated efficacy in modulating refractory pain in patients with chronic migraine, fibromyalgia, spinal cord injury, and trigeminal neuralgia. In addition, it has shown therapeutic benefits in several neurological and psychiatric disorders, including depression, stroke, epilepsy, and Parkinson's disease. The present study aims to evaluate the efficacy of anodal tDCS applied over the primary motor cortex as an adjunctive therapy for reducing headache frequency in patients with chronic migraine.

A total of 32 participants with chronic migraine will be enrolled and randomized using block randomization with a block size of four, stratified according to the presence or absence of medication-overuse headache (MOH), through an online randomization generator. Participants will be allocated to receive either active or sham tDCS. Before randomization, all eligible patients will maintain a baseline headache diary for four weeks while continuing their existing prophylactic medications. Thereafter, they will undergo three 20-minute stimulation sessions administered during weeks 1, 5, and 9. Treatment outcomes will be evaluated at weeks 5, 9, and 12 using headache diary records and predefined objective assessment tools.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

32

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 印度
      • New Delhi、印度、110001
        • Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital
        • 接触：
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Patients aged 18-60 years diagnosed with chronic migraine as per ICHD-3.
  2. Patients who were on a minimum of one concomitant preventive medication for not less than three months duration and a dose that was stable for at least one month prior to randomization.
  3. Willingness to provide informed consent and maintain a headache diary.

Exclusion Criteria:

  1. Patients with neurologic diseases such as tumours, seizures, dementia, meningitis, stroke, etc.
  2. Patients with barbiturate/opioid overuse or complications due to NSAID overuse.
  3. Patients failing to complete headache diary for more than 6 non-consecutive days during baseline.
  4. Illiterate patients without a caregiver to maintain the diary.
  5. Patients with pacemakers, cochlear implants.
  6. Pregnant women.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：卫生服务研究
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Anodal TDCS Arm (will receive true tDCS)
Will receive true Anodal tDCS
设备：Transcranial Direct Current stimulation
Patients in group A will receive true anodal stimulation
设备：Transcranial Direct Current stimulation
Patients in group B will receive Sham stimulation
假比较器：Sham tDCS Arm (will receive sham stimulation)
Will receive sham tDCS stimulation
设备：Transcranial Direct Current stimulation
Patients in group A will receive true anodal stimulation
设备：Transcranial Direct Current stimulation
Patients in group B will receive Sham stimulation

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in frequency of moderate-severe headache days (week 12 vs baseline).
大体时间：12 weeks
Change in the number of monthly moderate-to-severe headache days from baseline to Week 12, as recorded in the participant headache diary.
12 weeks

次要结果测量

结果测量
措施说明
大体时间
Change in migraine days (week 12 vs baseline).
大体时间：12 weeks
Change in the frequency of monthly migraine days from baseline to Week 12, as recorded in the participant headache diary.
12 weeks
50% responder rate
大体时间：12 weeks
The number of patients having a 50% reduction in migraine days per month in both groups was calculated at week 12
12 weeks
Change in headache severity (week 12 vs baseline).
大体时间：12 weeks
The change in headache severity will be assessed at week 12 from baseline in terms of visual analogue score (0-3)
12 weeks
Change in number of days with acute medication use (week 12 vs baseline)
大体时间：12 weeks
Change in the number of days requiring acute migraine medication use per month from baseline to Week 12, as recorded in the participant headache diary.
12 weeks
Change in PHQ-9 scores (week 12 vs baseline)
大体时间：12 weeks
Change in Patient Health Questionnaire-9 (PHQ-9) scores from baseline to Week 12
12 weeks
Change in MIDAS score (week 12 vs baseline)
大体时间：12 weeks
Change in Migraine Disability Assessment (MIDAS) scores from baseline to Week 12, assessing changes in migraine-related disability.
12 weeks
Change in HIT - 6 scores (week 12 vs baseline)
大体时间：12 weeks
Change in Headache Impact Test-6 (HIT-6) scores from baseline to Week 12, assessing the impact of headache on daily functioning and health-related quality of life.
12 weeks
Change in Migraine specific Quality of Life (week 12 vs baseline)
大体时间：12 weeks
Change in Migraine-Specific Quality of Life (MSQ) scores from baseline to Week 12, assessing changes in migraine-related quality of life.
12 weeks
Safety Outcome - Adverse events reported by the patients after each session of tDCS
大体时间：12 weeks
Incidence and severity of adverse events reported by participants following each transcranial direct current stimulation (tDCS) session, monitored throughout the study period.
12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Dr. Ram Manohar Lohia Hospital

调查人员

  • 首席研究员：Ashish K Duggal, DM Neurology、ABVIMS and Dr RML Hospital, New Delhi

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年1月31日

研究完成 (估计的)

2027年1月31日

研究注册日期

首次提交

2026年7月29日

首先提交符合 QC 标准的

2026年7月29日

首次发布 (实际的)

2026年8月4日

研究记录更新

最后更新发布 (实际的)

2026年8月4日

上次提交的符合 QC 标准的更新

2026年7月29日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IEC/ABVIMS/RMLH/394

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

IPD collected throughout the trial will be available from the Principle Investigator upon reasonable request.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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