Chronic Migraine HeadachePhase 3NCT07743814
EFFECT OF ANODAL TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS) OF PRIMARY MOTOR CORTEX ON HEADACHE FREQUENCY IN PATIENTS WITH CHRONIC MIGRAINE
A Phase 3 study testing Transcranial Direct Current stimulation in people with Chronic Migraine Headache and Chronic Migraine, Headache, run by Dr. Ram Manohar Lohia Hospital at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Migraine Headache, Chronic Migraine, Headache
- What is being tested?
- Transcranial Direct Current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2026to 31 Jan 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital
New Delhi, 110001
Ashish Duggal, DM (Neurology), +919810523332, ashishduggal2005@gmail.com
Ketan Bhatnagar, Pursuing DM Neurology, +917062874305, Ketanbhatnagar2024@gmail.com
About this study
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.
- Being tested
- Transcranial Direct Current stimulation
- Keywords
- tDCS, Chronic Migraine, Neuromodulation, Chronic Headache, Primary motor cortex
- Medical subject headings
- Headache, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current stimulationDevice
Patients in group A will receive true anodal stimulation
Transcranial Direct Current stimulationDevice
Patients in group B will receive Sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| Anodal TDCS Arm (will receive true tDCS) | Experimental | Will receive true Anodal tDCS Receives: Device: Transcranial Direct Current stimulation |
| Sham tDCS Arm (will receive sham stimulation) | Sham comparator | Will receive sham tDCS stimulation Receives: Device: Transcranial Direct Current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (9)
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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Migraine HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Ram Manohar Lohia Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Ashish Kumar Duggal, Dr. Ram Manohar Lohia Hospital
- Investigators
- Ashish K Duggal, DM Neurology, Principal investigator, ABVIMS and Dr RML Hospital, New Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743814
- Sponsor's protocol ID
- IEC/ABVIMS/RMLH/394
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD collected throughout the trial will be available from the Principle Investigator upon reasonable request.