Идёт набор NCT07304401

Evaluation of Effectiveness of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy for Treatment of Chemotherapy Induced Peripheral Neuropathy

— Наблюдательное Chemotherapy Induced Peripheral Neuropathy (CIPN) Neuropathic Pain

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Chemotherapy Induced Peripheral Neuropathy (CIPN), Neuropathic Pain. Базовые параметры: от 18 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: Нидерланды
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

Assessment of Effectiveness of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy on Pain Reduction and Improvement of Quality of Life in Patients With Chemotherapy Induced Peripheral Neuropathy

Обзор

The goal of this observational study is to learn about the effectiveness of closed-loop spinal cord stimulation (CL-SCS) therapy for treatment of painful chemotherapy induced peripheral neuropathy. The closed-loop SCS (CL-SCS) system stimulates the nerves in the spinal cord, measures their responses and automatically adjust the stimulation level accordingly in real time for each delivered pulse.

Подробное описание

Chemotherapy induced peripheral neuropathy (CIPN) is a serious condition that is diagnosed in up to 40% of patients who require chemotherapy. Conventional treatments for painful CIPN include both pharmacological and non-pharmacological interventions, although the underlying evidence is scarce. Spinal cord stimulation is an established treatment for pain associated with painful peripheral neuropathies. Several studies demonstrate pain relief by open-loop spinal cord stimulation (SCS) in patients with painful CIPN, with a positive effect of SCS on pain and quality of life. In the Netherlands, CIPN is an accepted indication for SCS treatment and thus SCS is a regular treatment for patients with painful and refractory CIPN. The closed-loop SCS (CL-SCS) system stimulates the dorsal column in the spinal cord, measures the response through evoked compound action potentials (ECAPs), and automatically adjust the stimulation level accordingly in real time for each delivered pulse.

The current study aims to evaluate the effectiveness of closed-loop spinal cord stimulation (CL-SCS) therapy in patients with CIPN.

Первичные конечные точки

Overall pain intensity [Срок оценки: The difference between baseline and the evaluation at 1, 3, 6 and 12 months after SCS implantation.]

Вторичные конечные точки (9)

Pain intensity for the extremities (arms and/or legs) [Срок оценки: The difference between baseline and the evaluation at 1, 3, 6 and 12 months after SCS implantation.]
9-Item Patient-Reported Outcomes Measurement Information System (PROMIS-29) [Срок оценки: The difference between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.]
CIPN-related symptoms [Срок оценки: The change between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.]
Medication use [Срок оценки: The change between baseline and the evaluation 1, 3, 6 and 12 months after treatment with closed-loop SCS]
Patient Global Impression of Change (PGIC) [Срок оценки: The change between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.]
Stimulation coverage and patient stimulation awareness and satisfaction [Срок оценки: Evaluation at 1, 3, 6 and 12 months after SCS implantation]
SCS stimulation pulse width [Срок оценки: Evaluation at 1, 3, 6 and 12 months after SCS implantation.]
SCS stimulation frequency [Срок оценки: Evaluation at 1, 3, 6 and 12 months after SCS implantation.]
(Serious) adverse events [Срок оценки: Evaluation at 1, 3, 6 and 12 months after SCS implantation]

Критерии участия

Subject is deemed a suitable candidate for SCS implantation and has been routinely scheduled to undergo an SCS implantation with the Evoke SCS System.
Subject has a minimum of leg or arm pain intensity of 5/10 on the numeric rating scale (NRS) at baseline due to CIPN.
Patients with CIPN following chemotherapy and at least 6 months post-treatment
CIPN symptoms for a minimum duration of 3 months.
Patient deemed to be in remission per discretion of treating oncologist
No existing contraindications for SCS
Subject is ≥ 18 years old.
Subject is not pregnant or nursing.
Subject is willing and capable of giving informed consent.
No satisfactory treatment effect with anti-neuropathic medication or intolerable side-effects
No satisfactory treatment effect with minimal invasive pain treatments (including ketamine or lidocaine infusion therapy)