A Phase 3 interventional study of Transcranial Direct Current stimulation and Transcranial Direct Current stimulation in Chronic Migraine Headache and Chronic Migraine, Headache, sponsored by Dr. Ram Manohar Lohia Hospital. Not yet recruiting at 1 site in India. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Dr. Ram Manohar Lohia Hospital · Phase 3, Interventional, and Health services research
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.
762 studies on the registry are indexed under Headache; 134 are open to participants now.
This study's planned enrollment of 32 is below the median of 65 across 560 interventional studies indexed under Headache.
Browse Headache studies →Dr. Ram Manohar Lohia Hospital is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Will receive true Anodal tDCS
Device: Transcranial Direct Current stimulation
Will receive sham tDCS stimulation
Device: Transcranial Direct Current stimulation
Patients in group A will receive true anodal stimulation
Patients in group B will receive Sham stimulation
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD collected throughout the trial will be available from the Principle Investigator upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Start is estimated for Aug 2026; primary completion for Jan 2027, 5 months later.
Of 30 phase 3 interventional studies under Headache, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Dr. Ram Manohar Lohia Hospital