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

29 juli 2026 uppdaterad av: Dr Ashish Kumar Duggal, Dr. Ram Manohar Lohia Hospital

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

32

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Indien
      • New Delhi, Indien, 110001
        • Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital
        • Kontakt:
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Anodal TDCS Arm (will receive true tDCS)
Will receive true Anodal tDCS
Enhet: Transcranial Direct Current stimulation
Patients in group A will receive true anodal stimulation
Enhet: Transcranial Direct Current stimulation
Patients in group B will receive Sham stimulation
Sham Comparator: Sham tDCS Arm (will receive sham stimulation)
Will receive sham tDCS stimulation
Enhet: Transcranial Direct Current stimulation
Patients in group A will receive true anodal stimulation
Enhet: Transcranial Direct Current stimulation
Patients in group B will receive Sham stimulation

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in frequency of moderate-severe headache days (week 12 vs baseline).
Tidsram: 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.
12 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in migraine days (week 12 vs baseline).
Tidsram: 12 weeks
Change in the frequency of monthly migraine days from baseline to Week 12, as recorded in the participant headache diary.
12 weeks
50% responder rate
Tidsram: 12 weeks
The number of patients having a 50% reduction in migraine days per month in both groups was calculated at week 12
12 weeks
Change in headache severity (week 12 vs baseline).
Tidsram: 12 weeks
The change in headache severity will be assessed at week 12 from baseline in terms of visual analogue score (0-3)
12 weeks
Change in number of days with acute medication use (week 12 vs baseline)
Tidsram: 12 weeks
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.
12 weeks
Change in PHQ-9 scores (week 12 vs baseline)
Tidsram: 12 weeks
Change in Patient Health Questionnaire-9 (PHQ-9) scores from baseline to Week 12
12 weeks
Change in MIDAS score (week 12 vs baseline)
Tidsram: 12 weeks
Change in Migraine Disability Assessment (MIDAS) scores from baseline to Week 12, assessing changes in migraine-related disability.
12 weeks
Change in HIT - 6 scores (week 12 vs baseline)
Tidsram: 12 weeks
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.
12 weeks
Change in Migraine specific Quality of Life (week 12 vs baseline)
Tidsram: 12 weeks
Change in Migraine-Specific Quality of Life (MSQ) scores from baseline to Week 12, assessing changes in migraine-related quality of life.
12 weeks
Safety Outcome - Adverse events reported by the patients after each session of tDCS
Tidsram: 12 weeks
Incidence and severity of adverse events reported by participants following each transcranial direct current stimulation (tDCS) session, monitored throughout the study period.
12 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Dr. Ram Manohar Lohia Hospital

Utredare

  • Huvudutredare: Ashish K Duggal, DM Neurology, ABVIMS and Dr RML Hospital, New Delhi

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 augusti 2026

Primärt slutförande (Beräknad)

31 januari 2027

Avslutad studie (Beräknad)

31 januari 2027

Studieregistreringsdatum

Först inskickad

29 juli 2026

Först inskickad som uppfyllde QC-kriterierna

29 juli 2026

Första postat (Faktisk)

4 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IEC/ABVIMS/RMLH/394

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

IPD collected throughout the trial will be available from the Principle Investigator upon reasonable request.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF

Läkemedels- och apparatinformation, studiedokument

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Nej

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