EFFECT OF ANODAL TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS) OF PRIMARY MOTOR CORTEX ON HEADACHE FREQUENCY IN PATIENTS WITH CHRONIC MIGRAINE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial Direct Current stimulation, Transcranial Direct Current stimulation.
- Who it may be relevant to
- Registry conditions: Chronic Migraine Headache, Chronic Migraine, Headache. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Transcranial Direct Current stimulation
Patients in group A will receive true anodal stimulation - Device Transcranial Direct Current stimulation
Patients in group B will receive Sham stimulation
Primary outcome measures
- Change in frequency of moderate-severe headache days (week 12 vs baseline). [Time frame: 12 weeks]
Secondary outcome measures (9)
- Change in migraine days (week 12 vs baseline). [Time frame: 12 weeks]
- 50% responder rate [Time frame: 12 weeks]
- Change in headache severity (week 12 vs baseline). [Time frame: 12 weeks]
- Change in number of days with acute medication use (week 12 vs baseline) [Time frame: 12 weeks]
- Change in PHQ-9 scores (week 12 vs baseline) [Time frame: 12 weeks]
- Change in MIDAS score (week 12 vs baseline) [Time frame: 12 weeks]
- Change in HIT - 6 scores (week 12 vs baseline) [Time frame: 12 weeks]
- Change in Migraine specific Quality of Life (week 12 vs baseline) [Time frame: 12 weeks]
- Safety Outcome - Adverse events reported by the patients after each session of tDCS [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- Patients aged 18-60 years diagnosed with chronic migraine as per ICHD-3.
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Health services research
Study locations
India · 1 center
- Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital — New Delhi
Identifiers
NCT: NCT07743814 · IEC/ABVIMS/RMLH/394