Effects and Mechanism of Accelerated Intermittent Theta Burst Stimulation on Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Visual analogue scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
AiTBS group
Eligible patients were receive 5 days of AiTBS on left M1 within 10 days. Clinical and neurophysiological assessments were performed at baseline and after the last sessions.
干预措施: Repetitive transcranial magnetic stimulation (Device)
10Hz rTMS
Patients were assigned to receive 10 consecutive days of classic 10Hz rTMS intervention on left M1. Clinical and neurophysiological assessments were performed at baseline and after the last sessions.
干预措施: Repetitive transcranial magnetic stimulation (Device)
结局指标
主要结局
Visual analogue scale
时间窗: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention
It typically consists of a 10-centimeter straight line, with two endpoints representing extreme states of the measured experience. For example, when assessing pain, one end is labeled "0 (no pain at all)" and the other end "10 (worst pain imaginable, unbearable)". The individual being evaluated marks a point on the line that corresponds to their current experience. The score is determined by measuring the distance from this mark to the "0" end, converted into a numerical value ranging from 0 to 10 (where each centimeter equals 1 point). Higher scores indicate a stronger intensity of the experience.
次要结局
- short-form McGill Pain Questionnaire (SF-MPQ)(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)(Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention)
- The Patient Global Impression of Change (PGIC)(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)(Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention)
- The Beck Depression Inventory-II (BDI-II)(Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention)
- TMS-EEG(Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group)
研究者
Min Yan
prof.
Second Affiliated Hospital, School of Medicine, Zhejiang University