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Clinical Trials in India / NCT07743814
Starting soon Phase 3

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

NCT07743814 · tracked via the Priya Life Science India tracker
Sponsor
Dr. Ram Manohar Lohia Hospital
Phase
Phase 3
Started
2026-08-01
Last updated
2026-08-04

Condition(s) studied

Chronic Migraine HeadacheChronic Migraine, Headache

Investigational drug(s) / intervention(s)

Transcranial Direct Current stimulationTranscranial Direct Current stimulation

Transcranial Direct Current stimulation: Patients in group A will receive true anodal stimulation

Transcranial Direct Current stimulation: Patients in group B will receive Sham stimulation

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in frequency of moderate-severe headache days (week 12 vs baseline). — 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.

Trial sites (1)

FacilityCityRegionStatus
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital New Delhi India

More Dr. Ram Manohar Lohia Hospital trials in India

EFFECT OF ANODAL TRANSCRANIAL DIRECT CURRENT STIMULATION ON NAMING IN APHASIC PATIENTS WITH ACUTE ISCHEMIC STROKE Starting soon
Effect of Repetitive Bihemispheric Anodal Transcranial Direct Current Stimulation on Motor Function of Patients With Parkinson's Disease Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07743814 on ClinicalTrials.gov ↗ ← All trials in India