Меню
Набор скоро начнётся NCT07743814

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

Фаза III С лечением Chronic Migraine Headache Chronic Migraine, Headache

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transcranial Direct Current stimulation, Transcranial Direct Current stimulation.
Кому может быть актуально
Состояния в реестре: Chronic Migraine Headache, Chronic Migraine, Headache. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Индия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

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.

Вмешательства

  • Устройство Transcranial Direct Current stimulation
    Patients in group A will receive true anodal stimulation
  • Устройство Transcranial Direct Current stimulation
    Patients in group B will receive Sham stimulation

Первичные конечные точки

  • Change in frequency of moderate-severe headache days (week 12 vs baseline). [Срок оценки: 12 weeks]
Вторичные конечные точки (9)
  • Change in migraine days (week 12 vs baseline). [Срок оценки: 12 weeks]
  • 50% responder rate [Срок оценки: 12 weeks]
  • Change in headache severity (week 12 vs baseline). [Срок оценки: 12 weeks]
  • Change in number of days with acute medication use (week 12 vs baseline) [Срок оценки: 12 weeks]
  • Change in PHQ-9 scores (week 12 vs baseline) [Срок оценки: 12 weeks]
  • Change in MIDAS score (week 12 vs baseline) [Срок оценки: 12 weeks]
  • Change in HIT - 6 scores (week 12 vs baseline) [Срок оценки: 12 weeks]
  • Change in Migraine specific Quality of Life (week 12 vs baseline) [Срок оценки: 12 weeks]
  • Safety Outcome - Adverse events reported by the patients after each session of tDCS [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Организация здравоохранения

Центры проведения

Индия · 1 центр
  • Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital — New Delhi

Идентификаторы

NCT: NCT07743814 · IEC/ABVIMS/RMLH/394

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗