Efficacy of Non-Invasive Neuromodulation on Pain in Migraine

Обзор

This is a prospective clinical study evaluating the analgesic efficacy of a non-medicated treatment: repeated transcranial magnetic stimulation (rTMS) of the primary motor cortex in chronic migraine (\> 7 headache days per month and failure of at least 3 drug treatments). To this end, the study involves a double-blind, randomized, comparative experimental protocol against a sham control condition via 2 parallel groups comprising 60 patients each (N= 120 in total). Randomized block design with stratification by center and type of migraine (episodic or chronic). 5 rTMS sessions will be performed, with one stimulation session every 2 weeks. One group will receive active stimulation at each session (high-frequency stimulation of the left primary motor cortex, 2000 pulses per session, 80% of resting motor threshold) and the other group placebo stimulation (sham). Depending on the randomization group, rTMS sessions will be carried out by trained experimenters in the investigating center where the patient has been included. The study is multicentric, with five centers, four of which are in the Auvergne-Rhône-Alpes region. Data will be centralized at the Clermont-Ferrand University Hospital, and statistical analysis will be carried out by the Clermont-Ferrand University Hospital's Clinical Research and Innovation Department. Principal difference analysis (active vs sham) performed in ITT; missing data processed by multiple imputation.

Вмешательства

• Устройство repetitive Transcranial Magnetic Stimulation (rTMS)
  robot-guided high-frequency rTMS treatment (10hz - 5 sessions) of the primary motor cortex
• Устройство sham repetitive Magnetic Transcranial Stimulation (rTMS)
  sham robot-guided high-frequency rTMS treatment (10hz - 5 sessions) of the primary motor cortex

Первичные конечные точки

• Variation of headaches days number per month [Срок оценки: difference between the 4 weeks prior to initiation of treatment and the last 4 weeks post-treatment]

Вторичные конечные точки (3)

• variation in the number of headache (days per month) of at least 50% [Срок оценки: between the 4 weeks prior to initiation of treatment and the last 4 weeks post-treatment]
• variation in the number of headache (days per month) of at least 30%. [Срок оценки: between the 4 weeks prior to initiation of treatment and the last 4 weeks post-treatment]
• Patient Global Impression of Change (PGIC) [Срок оценки: at week 12]

Критерии участия

Критерии включения

• Age greater than or equal to 18 years ;
• Frequent episodic or chronic migraine: migraine more than 8 days per month for more than 3 months;
• Maximum 26 headache days / 28 ;
• Failure (ineffectiveness, intolerance or contraindication) to at least 3 background drug treatments;
• Analgesic treatment stable for at least one month and will not need to be modified for the duration of the study;
• Patient can be followed throughout the study;
• Information letter read and understood;
• Signed informed consent;
• Affiliation with a social security scheme.

Критерии исключения

• Contraindication to rTMS (patient with conductive/sensitive material to magnetic fields implanted in the skull or less than 30 cm from the coil, implanted material controlled by physiological signals, history of epilepsy or unexplained seizures, drug treatment lowering the epileptic threshold, brain lesions in relation to the stimulation zone \[of vascular, traumatic, tumoral, infectious or metabolic origin\], sleep deprivation, alcoholism, treatment with electroconvulsive therapy in the previous month, uncontrolled intracranial hypertension,
• Contraindication to MRI (ferromagnetic material not compatible with MRI including: intracerebral metal clip, pacemaker, insulin pump, intrathecal pump, metal prosthesis; severe claustrophobia)§ drug or psychoactive substance abuse
• Presence of other pain more severe than that justifying inclusion
• Patients under guardianship or deprived of liberty.
• Pregnant or breast-feeding women
• Patients participating in another research protocol involving a drug in the 30 days prior to inclusion.
• Subject having already benefited from rTMS sessions in the past (to maintain the blind)

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

Лечение

Центры проведения

Франция · 1 центр

• CHU Clermont-Ferrand — Clermont-Ferrand

Идентификаторы

NCT: NCT07081685 · PHRC I 2023 MOISSET · 2024-A01985-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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