Идёт набор NCT05398003

Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)

Без фазы С лечением Pain, Intractable

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: Implantation of the WAVEWRITER ALPHA ™ device.
Кому может быть актуально: Состояния в реестре: Pain, Intractable. Базовые параметры: 18 лет — 85 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: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluation of Multimodal Medullary Stimulation in Refractory Neck and Upper Limb Pain

Обзор

Number of centres planned : 1 (CHU Nantes) Design : Randomized, Prospective Planning of the study : * Total duration: 34 months * Recruitment period: 24 months. * Follow-up time per patients : 7-10 months Expected number of cases : 12 Treatment, procedure, combination of procedures under consideration : During the study, patients will be implanted with the WAVEWRITER ALPHA™ system with the objective of decreasing patient pain with a spinal cord stimulation mode. There will be a random draw on the order of the stimulation program: * the tonic stimulation "LF": In tonic mode, the electrical stimulation of the sensory fibers of the posterior cords of the spinal cord induces local paresthesias * burst stimulation (or "burst") * high frequency" stimulation (1000 Hz) "High frequency: HF". * combined tonic + burst stimulation * combined tonic + high frequency stimulation

Вмешательства

Устройство Implantation of the WAVEWRITER ALPHA ™ device
The 12 patients will be implanted by the WAVEWRITER ALPHA ™ device. Then, the order of the three stimulation modes will be randomly selected and will be composed of 5 modalities: * tonic stimulation "LF": In tonic mode, the electrical stimulation of the sensory fibres of the posterior cords of the spinal cord induces local paresthesias * high frequency" stimulation (1000 Hz) "High Frequency". * stimulation in bursts (or "Burst")

Первичные конечные точки

Evaluating the non-inferiority of pain reduction with the combined mode compared to the low frequency reference mode. [Срок оценки: 6 Months]
Evaluating the overall satisfaction with the stimulation mode [Срок оценки: 6 Months]
Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode. [Срок оценки: 6 Months]

Вторичные конечные точки (12)

Evaluating the non-inferiority of patient pain with the combined mode compared to the low frequency reference mode [Срок оценки: 6 Months]
Evaluating the non-inferiority of patient satisfaction with their overall comfort [Срок оценки: 6 Months]
Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode. [Срок оценки: 6 Months]
Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + burst vs Low frequency [Срок оценки: 6 Months]
Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + high frequency vs Low frequency [Срок оценки: 6 Months]
Evaluating the superioty of pain reduction with the combined mode (low frequency + high frequency) compared to the tonic mode (low frequency) only [Срок оценки: 6 Months]
Evaluating the superioty of pain reduction with the combined mode (low frequency + Burst) compared to the tonic mode (low frequency) only [Срок оценки: 6 Months]
Evaluate the equality of the effectiveness of the new modes (Burst, high frequency, Tonic + Burst, Tonic + high frequency) compared to the tonic mode alone on the pain criteria [Срок оценки: 6 Months]
Evaluate the equality of the effectiveness of the new modes (Burst, high frequency, Tonic + Burst, Tonic + high frequency) compared to the tonic mode alone on the satisfaction [Срок оценки: 6 Months]
Comparison of the number of recharges of the device according to the stimulation modes [Срок оценки: 6 Months]
Evaluating the change in the quality of life of patients at 1 month [Срок оценки: 1 month]
Evaluating the change in the quality of life of patients at 1 month [Срок оценки: 1 month]

Критерии участия

Критерии включения

Patients aged 18 to 85 years
Patients with chronic neck and upper limb pain (according to HAS criteria for spinal cord stimulation)
Patients must be able to give informed consent and must have signed an informed consent
Affiliation to the health insurance
A negative pregnancy test for women of childbearing potential
Women of childbearing potential must use an appropriate contraceptive method(s) during the clinical trial

Non-inclusion criteria:

Drug or alcohol abuse
Any medical or psychological problem that may interfere with the proper conduct of the study protocol (e.g., cancer with limited life expectancy)
Difficulty with follow-up
Pregnant or breastfeeding women
Women of childbearing potential who are not using contraception
Adults under legal protection (guardianship, curatorship, "sauvegarde de justice") or deprived of liberty
Exclusion period for another study
Participation in another interventional study whose primary objective is based on pain.