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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Enrollment
32
Patients in group A will receive true anodal stimulation
Patients in group B will receive Sham stimulation
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital
New Delhi, India
Change in frequency of moderate-severe headache days (week 12 vs baseline).
Change in the number of monthly moderate-to-severe headache days from baseline to Week 12, as recorded in the participant headache diary.
Time frame: 12 weeks
Change in migraine days (week 12 vs baseline).
Change in the frequency of monthly migraine days from baseline to Week 12, as recorded in the participant headache diary.
Time frame: 12 weeks
50% responder rate
The number of patients having a 50% reduction in migraine days per month in both groups was calculated at week 12
Time frame: 12 weeks
Change in headache severity (week 12 vs baseline).
The change in headache severity will be assessed at week 12 from baseline in terms of visual analogue score (0-3)
Time frame: 12 weeks
Change in number of days with acute medication use (week 12 vs baseline)
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.
Time frame: 12 weeks
Change in PHQ-9 scores (week 12 vs baseline)
Change in Patient Health Questionnaire-9 (PHQ-9) scores from baseline to Week 12
Time frame: 12 weeks
Change in MIDAS score (week 12 vs baseline)
Change in Migraine Disability Assessment (MIDAS) scores from baseline to Week 12, assessing changes in migraine-related disability.
Time frame: 12 weeks
Change in HIT - 6 scores (week 12 vs baseline)
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.
Time frame: 12 weeks
Change in Migraine specific Quality of Life (week 12 vs baseline)
Change in Migraine-Specific Quality of Life (MSQ) scores from baseline to Week 12, assessing changes in migraine-related quality of life.
Time frame: 12 weeks
Safety Outcome - Adverse events reported by the patients after each session of tDCS
Incidence and severity of adverse events reported by participants following each transcranial direct current stimulation (tDCS) session, monitored throughout the study period.
Time frame: 12 weeks
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