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Идёт набор NCT06726954

Repetitive Transcranial Magnetic Stimulation Therapy in Spinal Cord Injury Related Neuropathic Pain

Без фазы С лечением Spinal Cord Injuries 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
В протоколе указаны: High-frequency real-time rTMS DLPF cortex protocol, High-frequency real-time rTMS M1 motor cortex protocol, Sham rTMS Protocol.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injuries, Neuropathic Pain. Базовые параметры: 18 лет — 75 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Efficacy of Repetitive Transcranial Magnetic Stimulation Therapy in Neuropathic Pain Associated With Spinal Cord Injury; Randomized Controlled Trial

Обзор

The aim of our study is to investigate the effect of different protocols of high-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) therapy added to the rehabilitation program on neuropathic pain,depression, quality of life and quality of sleep compared to each other and placebo group in participants with spinal cord injury.

Подробное описание

Spinal cord injury is a disability that causes the loss of many functions for example motor,sensory and autonomic functions in the body. Neuropathic pain is a common problem in participants with spinal cord injury. Many treatment options have been offered for a debilitating condition that has major negative effects on participant's quality of life but provides limited effects and many secondary effects. There is evidence for neuromodulation techniques to improve many pain conditions, such as neuropathic pain. One innovative method for neuropathic pain management, rTMS, is a non-invasive neuromodulation intervention with a low risk of side effects that works by altering brain activity. While most studies to date have mainly targeted the primary motor cortex (M1), fewer studies have reported analgesic effects after stimulation of other cortical areas such as the dorsolateral prefrontal cortex (DLPFC).

The initial assessment will include answering questionnaires: Brief Pain Inventory, Neuropathic Pain Symptom Inventory(NPSI), International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version, Patient Catastrophizing Scale(PCS), Beck Depression Inventory,Quality of Life Index Spinal Cord Injury v3 (QLI-SCI), Pain Catastrophizing Scale (PCS),Pittsburgh Sleep Quality Index and previous medication and treatment questionnaires.Participants will be asked to complete the above-mentioned questionnaires post-rTMS treatment and at 2 months after their last rTMS treatment.

TMS Protocol: Participants will undergo high frequency rTMS sessions 5 days a week for 4 weeks (20 treatments total). Daily rTMS sessions will include at a frequency of 10 Hz, treatment intensity will be applied at 120% of the participants resting motor threshold (RMT). A RMT is the minimal intensity required to evoke a motor evoked potential and will be obtained by administering single-pulse TMS to the left motor cortex participant a will be seated in a comfortable chair or their wheelchair for each rTMS session.

Participants with spinal cord injury receiving rTMS in DLPFC or M1 protocol in addition to neurological rehabilitation will be compared with the sham rTMS group in terms of neuropathic pain, sleep quality, depression and quality of life.

Вмешательства

  • Устройство High-frequency real-time rTMS DLPF cortex protocol
    It was planned to apply the dorsolateral prefrontal cortex daily for 20 sessions.Along with the daily rTMS session, participants will continue to use the medications in the medical treatment at the same effective dose and no dose changes will be made during the treatment.
  • Устройство High-frequency real-time rTMS M1 motor cortex protocol
    It was planned to apply the M1 motor cortex daily for 20 sessions.Along with the daily rTMS session, participants will continue to use the medications in the medical treatment at the same effective dose and no dose changes will be made during the treatment.
  • Устройство Sham rTMS Protocol
    It was planned to apply the daily for 20 sessions.Along with the daily rTMS session, participants will continue to use the medications in the medical treatment at the same effective dose and no dose changes will be made during the treatment.

Первичные конечные точки

  • Change from baseline Brief Pain Inventory-Short Form (BPI-SF) at 1. and 2 months. [Срок оценки: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.]
Вторичные конечные точки (8)
  • Change from baseline International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) self-report version at 1. and 2 months. [Срок оценки: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.]
  • Change from baseline Quality of Life Index Spinal Cord Injury version (QLI-SCI) at 1. and 2 months. [Срок оценки: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.]
  • Change from baseline Pain Catastrophizing Scale (PCS) at 1. and 2 months. [Срок оценки: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.]
  • Change from baseline Beck Depression Inventory (BDI) Scores at 1. and 2 months. [Срок оценки: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.]
  • Change in the Patient's Global Impression of Change (PGIC) observed at 1 month and 2 months. [Срок оценки: To be assessed after rTMS treatment (1-month) and 2-months after rTMS treatment.]
  • Change from baseline Neuropathic Pain Symptom Inventory (NPSI) at 1.and 2 months. [Срок оценки: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.]
  • Change from baseline Pittsburgh Sleep Quality Index (PSQI) at 1. and 2 months. [Срок оценки: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.]
  • Change from baseline Modified Ashworth Scale (MAS) at 1. and 2 months. [Срок оценки: To be assessed at baseline, after rTMS treatment (1-month) and 2-months after rTMS treatment.]

Критерии участия

Критерии включения

Aged 18-75 years Physician-diagnosed spinal cord injury for at least 3-months Neuropathic pain for at least 3-months Pain not attributable to any other conditions

Критерии исключения

  • Having an important comorbid disease such as severe heart disease (aortic stenosis, angina, hypertrophic cardiomyopathy, uncontrolled hypertension,arrhythmia, pacemaker)
  • Neurodegenerative disease
  • Epilepsy
  • History of antiepileptic drug use
  • Cognitive dysfunction
  • Lower extremity peripheral nerve injury
  • Increased intracranial pressure or uncontrolled migraine
  • Infection on the skin in the application area.
  • Having a brain lesion or a history of drug use that will affect the seizure threshold.

Any TMS-related contraindications, for example:

  • Pacemaker
  • Metallic implant
  • Previous seizure
  • Psychiatric disorders (excluding depression and anxiety)
  • Malignancy
  • Current pregnancy

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

Turkey (Türkiye) · 1 центр
  • Afyonkarahisar Health Sciences University — Afyonkarahisar

Публикации

  • Attal N, Poindessous-Jazat F, De Chauvigny E, Quesada C, Mhalla A, Ayache SS, Fermanian C, Nizard J, Peyron R, Lefaucheur JP, Bouhassira D. Repetitive transcranial magnetic stimulation for neuropathic pain: a randomized multicentre sham-controlled trial. Brain. 2021 Dec 16;144(11):3328-3339. doi: 10.1093/brain/awab208. PMID 34196698
  • Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on th PMID 31901449
  • Saleh C, Ilia TS, Jaszczuk P, Hund-Georgiadis M, Walter A. Is transcranial magnetic stimulation as treatment for neuropathic pain in patients with spinal cord injury efficient? A systematic review. Neurol Sci. 2022 May;43(5):3007-3018. doi: 10.1007/s10072-022-05978-0. Epub 2022 Mar 3. PMID 35239053

Идентификаторы

NCT: NCT06726954 · TMSSCINP

Первоисточники (государственные реестры)

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