EFFECT OF ANODAL TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS) OF PRIMARY MOTOR CORTEX ON HEADACHE FREQUENCY IN PATIENTS WITH CHRONIC MIGRAINE
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in frequency of moderate-severe headache days (week 12 vs baseline).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-60 years diagnosed with chronic migraine as per ICHD-
- •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.
- •Willingness to provide informed consent and maintain a headache diary.
排除标准
- •Patients with neurologic diseases such as tumours, seizures, dementia, meningitis, stroke, etc.
- •Patients with barbiturate/opioid overuse or complications due to NSAID overuse.
- •Patients failing to complete headache diary for more than 6 non-consecutive days during baseline.
- •Illiterate patients without a caregiver to maintain the diary.
- •Patients with pacemakers, cochlear implants.
- •Pregnant women.
结局指标
主要结局
Change in frequency of moderate-severe headache days (week 12 vs baseline).
时间窗: 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.
次要结局
- Change in migraine days (week 12 vs baseline).(12 weeks)
- 50% responder rate(12 weeks)
- Change in headache severity (week 12 vs baseline).(12 weeks)
- Change in number of days with acute medication use (week 12 vs baseline)(12 weeks)
- Change in PHQ-9 scores (week 12 vs baseline)(12 weeks)
- Change in MIDAS score (week 12 vs baseline)(12 weeks)
- Change in HIT - 6 scores (week 12 vs baseline)(12 weeks)
- Change in Migraine specific Quality of Life (week 12 vs baseline)(12 weeks)
- Safety Outcome - Adverse events reported by the patients after each session of tDCS(12 weeks)
研究者
Dr Ashish Kumar Duggal
Professor, Department of Neurology, ABVIMS and Dr RML Hospital, New Delhi
Dr. Ram Manohar Lohia Hospital