Accelerated Intermittent Theta Burst Stimulation (AiTBS)on Neuropathic Pain

Официальное название

Effects and Mechanism of Accelerated Intermittent Theta Burst Stimulation on Neuropathic Pain

Обзор

The present study was designed to be the first to evaluate the efficacy of the AiTBS protocol to relieve neuropathic pain in a therapeutic setting, i.e. with repeated stimulation sessions. The investigator directly compared the analgesic efficacy of AiTBS versus conventional 10-Hz rTMS delivered to the left M1. In addition to pain experiences, The investigator examined the effects of intervention on corticospinal excitability that assessed by TMS-EEG. The working hypothesis was that AiTBS would result in larger analgesic and significant cortical excitability changes compared to 10-Hz rTMS. Eligible patients were randomly assigned to receive either 5 days of AiTBS within 10 days (6 sessions per day) or 10 consecutive days of classic 10Hz rTMS intervention. Clinical and neurophysiological assessments were performed at baseline and after the last sessions.

Вмешательства

• Устройство Repetitive transcranial magnetic stimulation
  Patients in the AiTBS group received 5 consecutive days of AiTBS treatment, with 6 sessions of iTBS interventions per day (1800 pulses per trial, with a 50-minute interval between trials). Patients in the 10Hz rTMS group received 10 consecutive days of 10Hz rTMS treatment within 10 days, with 1500 pulses per day, totaling 15 minutes.

Первичные конечные точки

• Visual analogue scale [Срок оценки: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention]

Вторичные конечные точки (6)

• short-form McGill Pain Questionnaire (SF-MPQ) [Срок оценки: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention]
• 7-item pain interference scale of the Brief Pain Inventory (BPI) [Срок оценки: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention]
• The Patient Global Impression of Change (PGIC) [Срок оценки: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention]
• The 17-item Hamilton Depression Rating Scale (HAMD-17) [Срок оценки: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention]
• The Beck Depression Inventory-II (BDI-II) [Срок оценки: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention]
• TMS-EEG [Срок оценки: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group]

Критерии участия

Критерии включения

• IASP diagnosis of peripheral neuropathic pain;
• At least three months after the onset of pain;
• At least moderate pain intensity (≥ 3 assessed by VAS or NRS);
• 18 years or older;
• Stable medical treatment from 2 weeks before allocation to the end of the trial;
• Willing to receive TMS treatment and capable of fulfilling clinical assessments.

Критерии исключения

• Contradictions to TMS treatment, such as metal implants or seizure;
• Serious psychiatric disorder (Hamilton Depression Rating Scale score ≥ 35 or Hamilton Anxiety Rating Scale score ≥ 29);
• Aphasia or cognitive disorders (Mini mental state examination ≤ 24);
• Severe clinical disorders caused by tumor or other conditions;
• Severe cardiopulmonary dysfunction or extreme weakness;
• History of substance abuse (alcohol, drugs).

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07148388 · 2024-0669

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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